Literature Collection

Magnifying Glass
Collection Insights

12K+

References

11K+

Articles

1600+

Grey Literature

4800+

Opioids & SU

The Literature Collection contains over 11,000 references for published and grey literature on the integration of behavioral health and primary care. Learn More

Use the Search feature below to find references for your terms across the entire Literature Collection, or limit your searches by Authors, Keywords, or Titles and by Year, Type, or Topic. View your search results as displayed, or use the options to: Show more references per page; Sort references by Title or Date; and Refine your search criteria. Expand an individual reference to View Details. Full-text access to the literature may be available through a link to PubMed, a DOI, or a URL. References may also be exported for use in bibliographic software (e.g., EndNote, RefWorks, Zotero).

Enter Search Term(s)
Year
Sort by
Order
Show
101 Results
81
Retention strategies for medications for addiction treatment in adults with opioid use disorder: A rapid evidence review
Type: Government Report
Authors: B. Chan, E. Gean, I. Arkhipova-Jenkins, J. Gilbert, J. Hilgart, C. Fiordalisi, K. Hubbard, I. Brandt, E. Stoeger, R. Paynter, P. T. Korthuis, J. Guise
Year: 2020
Publication Place: Rockville, MD
Abstract:

AIMS: American deaths from opioid overdose now approach 50,000 annually. While evidence shows that medications for addiction treatment (MAT) save lives, retaining patients in MAT programs is challenging. The U.S. Agency for Healthcare Research and Quality, on behalf of the U.S. Department of Health and Human Services, commissioned a rapid evidence review on the effectiveness of interventions to promote a broader understanding of the published literature on MAT retention among adults with opioid use disorder (OUD). METHODS: We searched MEDLINE and the Cochrane Library from February 12, 2009, through June 16, 2019, for systematic reviews (SRs) and randomized controlled trials (RCTs). We summarized evidence for six retention intervention types: care settings/services/logistical support, contingency management, health information technology (IT), extended-release (XR) medication-based treatment, psychosocial support, and financial support. Our primary outcome was retention, defined as continued medication engagement for at least 3 months after MAT initiation. Secondary outcomes included mortality and harms. FINDINGS: Key findings from 2 SRs and 39 primary studies include: 1. Most studies of MAT for OUD do not focus on retention as the primary outcome, are small (e.g., one to two trials per intervention), and have design flaws. 2. Care setting interventions that initiated MAT in soon-to-be-released incarcerated patients improved retention following release. 3. Contingency management improved retention when combined with antagonist MAT, but not with agonist forms of MAT. Applicability, however, may be limited due to implementation challenges. 4. Preliminary trials suggest that retention in MAT supported with health IT approaches may be no worse than in-person approaches. 5. Early studies suggest no difference in retention with XR-buprenorphine in either injectable or implant formulations compared with daily buprenorphine. There were conflicting results with XR-naltrexone injection compared with daily buprenorphine. 6. The addition of psychosocial interventions did not improve retention; however, many studies included some form of counseling in the control groups, potentially obscuring evidence of effectiveness. Harms were infrequently reported across studies except in studies of XR formulations. Similarly, few studies reported whether participant characteristics influenced retention. CONCLUSIONS: While patients who receive longer-term treatment with MAT have improved outcomes, fewer than half of the identified studies measured treatment retention as a primary outcome. Limited evidence suggests criminal justice prerelease MAT initiation and the use of contingency management for patients on antagonist forms of MAT may aid retention. XR and daily buprenorphine formulations appear to be equivalent for treatment retention and comparisons of XR-naltrexone versus daily buprenorphine showed conflicting results. Integrating MAT treatment with medical and social services and the use of health IT did not change retention. Some studies were conducted outside of the United States, where policies and practices differ, focused on highly selected populations and/or conditions that are not fully representative of the spectrum of OUD, or were studied in situations that may not be easily implemented in real-world conditions. There is a critical need for studies that use standardized definitions of retention, include measures of harms as well as benefits, and reflect the full spectrum of real-life conditions.

Topic(s):
Grey Literature See topic collection
,
Healthcare Disparities See topic collection
,
Opioids & Substance Use See topic collection
Disclaimer:

This grey literature reference is included in the Academy's Literature Collection in keeping with our mission to gather all sources of information on integration. Grey literature is comprised of materials that are not made available through traditional publishing avenues. Often, the information from unpublished resources can be limited and the risk of bias cannot be determined.

82
Shared care across the interface between primary and specialty care in management of long term conditions
Type: Journal Article
Authors: S. M. Smith, G. Cousins, B. Clyne, S. Allwright, T. O'Dowd
Year: 2017
Publication Place: England
Abstract: BACKGROUND: Shared care has been used in the management of many chronic conditions with the assumption that it delivers better care than primary or specialty care alone; however, little is known about the effectiveness of shared care. OBJECTIVES: To determine the effectiveness of shared care health service interventions designed to improve the management of chronic disease across the primary/specialty care interface. This is an update of a previously published review.Secondary questions include the following:1. Which shared care interventions or portions of shared care interventions are most effective?2. What do the most effective systems have in common? SEARCH METHODS: We searched MEDLINE, Embase and the Cochrane Library to 12 October 2015. SELECTION CRITERIA: One review author performed the initial abstract screen; then two review authors independently screened and selected studies for inclusion. We considered randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after studies (CBAs) and interrupted time series analyses (ITS) evaluating the effectiveness of shared care interventions for people with chronic conditions in primary care and community settings. The intervention was compared with usual care in that setting. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included studies, evaluated study quality and judged the certainty of the evidence using the GRADE approach. We conducted a meta-analysis of results when possible and carried out a narrative synthesis of the remainder of the results. We presented the results in a 'Summary of findings' table, using a tabular format to show effect sizes for all outcome types. MAIN RESULTS: We identified 42 studies of shared care interventions for chronic disease management (N = 18,859), 39 of which were RCTs, two CBAs and one an NRCT. Of these 42 studies, 41 examined complex multi-faceted interventions and lasted from six to 24 months. Overall, our confidence in results regarding the effectiveness of interventions ranged from moderate to high certainty. Results showed probably few or no differences in clinical outcomes overall with a tendency towards improved blood pressure management in the small number of studies on shared care for hypertension, chronic kidney disease and stroke (mean difference (MD) 3.47, 95% confidence interval (CI) 1.68 to 5.25)(based on moderate-certainty evidence). Mental health outcomes improved, particularly in response to depression treatment (risk ratio (RR) 1.40, 95% confidence interval (CI) 1.22 to 1.62; six studies, N = 1708) and recovery from depression (RR 2.59, 95% CI 1.57 to 4.26; 10 studies, N = 4482) in studies examining the 'stepped care' design of shared care interventions (based on high-certainty evidence). Investigators noted modest effects on mean depression scores (standardised mean difference (SMD) -0.29, 95% CI -0.37 to -0.20; six studies, N = 3250). Differences in patient-reported outcome measures (PROMs), processes of care and participation and default rates in shared care services were probably limited (based on moderate-certainty evidence). Studies probably showed little or no difference in hospital admissions, service utilisation and patient health behaviours (with evidence of moderate certainty). AUTHORS' CONCLUSIONS: This review suggests that shared care improves depression outcomes and probably has mixed or limited effects on other outcomes. Methodological shortcomings, particularly inadequate length of follow-up, may account in part for these limited effects. Review findings support the growing evidence base for shared care in the management of depression, particularly stepped care models of shared care. Shared care interventions for other conditions should be developed within research settings, with account taken of the complexity of such interventions and awareness of the need to carry out longer studies to test effectiveness and sustainability over time.
Topic(s):
General Literature See topic collection
83
Six-month effects of integrative treatment, therapeutic acupuncture and conventional treatment in alleviating psychological distress in primary care patients--follow up from an open, pragmatic randomized controlled trial
Type: Journal Article
Authors: T. Arvidsdotter, B. Marklund, C. Taft
Year: 2014
Publication Place: England
Abstract: BACKGROUND: To evaluate and compare 6-month effects of 8 weeks of an integrative treatment (IT), therapeutic acupuncture (TA), and conventional treatment (CT) in reducing symptoms of anxiety, depression and in improving health-related quality of life (HRQL) and sense of coherence (SOC) in psychologically distressed primary care patients. METHODS: Patients who had participated in an open, pragmatic randomized controlled trial were followed up six months after treatment. The study sample consisted of 120 adults (40 per treatment arm) aged 20 to 55 years referred from four different primary health care centres in western Sweden for psychological distress. Assessments were made at baseline after eight weeks and after 24 weeks. Anxiety and depression were evaluated with the Hospital Anxiety and Depression scale (HADS), HRQL with the SF-36 Mental Component Summary scores (MCS) and SOC with the Sense of Coherence-13 questionnaire. RESULTS: No baseline differences were found between groups on any outcome variable. At 24 weeks, IT and TA had significantly better values than CT on all variables. All three groups showed significant improvements from baseline on all variables, except HAD depression in CT; however, improvements were significantly greater in IT and TA than in CT. IT and TA did not differ on any outcome variable. Effect sizes were large in IT and TA for all variables and small or moderate in CT. Improvements on all variables seen after 8-weeks of IT and TA remained stable at 24 weeks and the CT group improved on HAD anxiety. CONCLUSIONS: IT and TA seem to be more beneficial than CT in reducing anxiety, depression, and in improving quality of life and sense of coherence after 24 weeks of follow up in patients with psychological distress. More research is needed to confirm these results. TRIAL REGISTRATION: ISRCTN trial number NCT01631500.
Topic(s):
General Literature See topic collection
84
Slow-release oral morphine as maintenance therapy for opioid dependence
Type: Journal Article
Authors: M. Ferri, S. Minozzi, A. Bo, L. Amato
Year: 2013
Publication Place: England
Abstract: BACKGROUND: Opioid substitution treatments are effective in retaining people in treatment and suppressing heroin use. An open question remains whether slow-release oral morphine (SROM) could represent a possible alternative for opioid-dependent people who respond poorly to other available maintenance treatments. OBJECTIVES: To evaluate the efficacy of SROM as an alternative maintenance pharmacotherapy for the treatment of opioid dependence. SEARCH METHODS: We searched Cochrane Drugs and Alcohol Group's Register of Trials, Cochrane Central Register of Controlled Trials (CENTRAL - The Cochrane Library Issue 3, 2013), MEDLINE (January 1966 to April 2013), EMBASE (January 1980 to April 2013) and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-randomised trials assessing efficacy of SROM compared with other maintenance treatment or no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently selected articles for inclusion, extracted data and assessed risk of bias of included studies. MAIN RESULTS: Three studies with 195 participants were included in the review. Two were cross-over trials and one was a parallel group RCT. The retention in treatment appeared superior to 80% in all the three studies (without significant difference with controls). Nevertheless, it has to be underlined that the studies had different durations. One lasted six months, and the other two lasted six and seven weeks. The use of opioids during SROM provision varied from lower to non-statistically or clinically different from comparison interventions, whereas there were no differences as far as the use of other substances was concerned.SROM seemed to be equal to comparison interventions for severity of dependence, or mental health/social functioning, but there was a trend for less severe opiate withdrawal symptoms in comparison with methadone (withdrawal score 2.2 vs. 4.8, P value = 0.06). Morphine was generally well tolerated and was preferred by a proportion of participants (seven of nine people in one study). Morphine appeared to reduce cravings, depressive symptoms (measured using the Beck Depression Inventory; P value < 0.001), physical complaints (measured using the Beschwerde-Liste (BL); P value < 0.001) and anxiety symptoms (P value = 0.008). Quality of life in people treated with SROM resulted in no significant difference or a worst outcome than in those taking methadone and buprenorphine. Other social functioning measures, such as finances, family and overall satisfaction, scored better in people maintained with the comparison substances than in those maintained with SROM. In particular, people taking methadone showed more favourable values for leisure time (5.4 vs. 3.7, P value < 0.001), housing (6.1 vs. 4.7, P value < 0.023), partnerships (5.7 vs. 4.2, P value = 0.034), friend and acquaintances (5.6 vs. 4.4, P value = 0.003), mental health (5.0 vs. 3.4, P value = 0.002) and self esteem (8.2 vs. 5.7, P value = 0.002) compared to people taking SROM; while people taking buprenorphine obtained better scores for physical health.Medical adverse events were consistently higher in people in SROM than in the comparison groups. None of the studies included people with a documented poor response to other maintenance treatment. AUTHORS' CONCLUSIONS: The present review did not identify sufficient evidence to assess the effectiveness of SROM for opioid maintenance because only three studies meeting our inclusion criteria have been identified. Two studies suggested a possible reduction of opioid use in people taking SROM. In another study, the use of SROM was associated with fewer depressive symptoms. Retention in treatment was not significantly different among compared interventions while the adverse effects were more frequent with the people given SROM.
Topic(s):
Opioids & Substance Use See topic collection
85
Stimulant and Designer Drug Use: Primary Care Management
Type: Journal Article
Authors: A. E. Klega, J. T. Keehbauch
Year: 2018
Publication Place: United States
Abstract:

Approximately 10% of the U.S. population 12 years and older reported using illicit substances in 2015. This article reviews the clinical effects and treatment of persons who use cocaine, methamphetamines, 3,4-methylenedioxymethamphetamine (MDMA), synthetic cannabinoids, and synthetic cathinones ("bath salts"). Cocaine blocks the reuptake of the monoamine transporters dopamine, norepinephrine, and serotonin. Immediate clinical effects include increased energy and euphoria, as well as hypertension and arrhythmias. Acute myocardial infarction, seizures, hallucinations, hyperthermia, and movement disorders are among the possible adverse effects. Like cocaine, methamphetamine blocks reuptake of monoamine transporters, but also stimulates dopamine release and has a longer duration of action. Methamphetamine misuse is associated with severe dental problems. MDMA is a stimulant and psychedelic with a chemical structure similar to serotonin. Adverse effects include serotonin syndrome, hyponatremia, long-term memory impairment, and mood disorders. Synthetic cannabinoids can have a more intense and long-lasting effect than natural cannabis. Acute intoxication may cause severe cardiac and respiratory complications and seizures. Synthetic cathinones are marketed as cheap substitutes for other stimulants. Their effects are similar to those of other stimulants, and they are addictive. Psychosocial intervention is the main form of treatment for addiction to these substances. Promising therapies include disulfiram and substitution therapy for cocaine misuse disorders, and mirtazapine for methamphetamine use disorder.

Topic(s):
Opioids & Substance Use See topic collection
86
Supervised dosing with a long-acting opioid medication in the management of opioid dependence
Type: Journal Article
Authors: R. Saulle, S. Vecchi, L. Gowing
Year: 2017
Publication Place: England
Abstract: BACKGROUND: Opioid dependence (OD) is an increasing clinical and public health problem worldwide. International guidelines recommend opioid substitution treatment (OST), such as methadone and buprenorphine, as first-line medication treatment for OD. A negative aspect of OST is that the medication used can be diverted both through sale on the black market, and the unsanctioned use of medications. Daily supervised administration of medications used in OST has the advantage of reducing the risk of diversion, and may promote therapeutic engagement, potentially enhancing the psychosocial aspect of OST, but costs more and is more restrictive on the client than dispensing for off-site consumption. OBJECTIVES: The objective of this systematic review is to compare the effectiveness of OST with supervised dosing relative to dispensing of medication for off-site consumption. SEARCH METHODS: We searched in Cochrane Drugs and Alcohol Group Specialised Register and Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, Web of Science from inception up to April 2016. Ongoing and unpublished studies were searched via ClinicalTrials.gov (www.clinicaltrials.gov) and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/en/).All searches included non-English language literature. We handsearched references on topic-related systematic reviews. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled clinical trials (CCTs), and prospective controlled cohort studies, involving people who are receiving OST (methadone, buprenorphine) and comparing supervised dosing with dispensing of medication to be consumed away from the dispensing point, usually without supervision. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: Six studies (four RCTs and two prospective observational cohort studies), involving 7999 participants comparing supervised OST treatment with unsupervised treatment, met the inclusion criteria. The risk of bias was generally moderate across trials, but the results reported on outcomes that we planned to consider were limited. Overall, we judged the quality of the evidence from very low to low for all the outcomes.We found no difference in retention at any duration with supervised compared to unsupervised dosing (RR 0.99, 95% CI 0.88 to 1.12, 716 participants, four trials, low-quality evidence) or in retention in the shortest follow-up period, three months (RR 0.94; 95% CI 0.84 to 1.05; 472 participants, three trials, low-quality evidence). Additional data at 12 months from one observational study found no difference in retention between groups (RR 0.94, 95% CI 0.77 to 1.14; n = 300).There was no difference in abstinence at the end of treatment (self-reported drug use) (67% versus 60%, P = 0.33, 293 participants, one trial, very low-quality evidence); and in diversion of medication (5% versus 2%, 293 participants, one trial, very low-quality evidence).Regarding our secondary outcomes, we did not found a difference in the incidence of adverse effects in the supervised compared to unsupervised control group (RR 0.63; 96% CI 0.10 to 3.86; 363 participants, two trials, very low-quality evidence). Data on severity of dependence were very limited (244 participants, one trial) and showed no difference between the two approaches. Data on deaths were reported in two studies. One trial reported two deaths in the supervised group (low-quality evidence), while in the cohort study all-cause mortality was found lower in regular supervision group (crude mortality rate 0.60 versus 0.81 per 100 person-years), although after adjustment insufficient evidence existed to suggest that regular supervision was protective (mortality rate ratio = 1.23, 95% CI = 0.67 to 2.27).No studies reported pain symptoms, drug craving, aberrant opioid-related behaviours, days of unsanctioned opioid use and overdose. AUTHORS' CONCLUSIONS: Take-home medication strategies are attractive to treatment services due to lower costs, and place less restrictions on clients, but it is unknown whether they may be associated with increased risk of diversion and unsanctioned use of medication. There is uncertainty about the effects of supervised dosing compared with unsupervised medication due to the low and very low quality of the evidence for the primary outcomes of interest for this review. Data on defined secondary outcomes were similarly limited. More research comparing supervised and take-home medication strategies is needed to support decisions on the relative effectiveness of these strategies. The trials should be designed and conducted with high quality and over a longer follow-up period to support comparison of strategies at different stages of treatment. In particular, there is a need for studies assessing in more detail the risk of diversion and safety outcomes of using supervised OST to manage opioid dependence.
Topic(s):
Financing & Sustainability See topic collection
,
Opioids & Substance Use See topic collection
87
Systematic review and meta-analysis of combined cognitive-behavioral therapy and physical activity and exercise interventions for pediatric chronic disease
Type: Journal Article
Authors: W. R. Black, L. von Klinggraeff, D. A. White, B. Forseth, J. L. Jackson, C. R. Bates, C. D. Pfledderer, S. Dobbins, K. R. Hoskinson, A. Gehred, A. M. Davis
Year: 2024
Abstract:

OBJECTIVE: Cognitive-behavioral (CBT) interventions combined with either a physical activity (CBT+PA) or exercise intervention (CBT+Ex) are becoming more common in pediatric populations. Considering the independent effects of PA and exercise on health and psychological outcomes, it is unclear whether CBT alone differs from CBT+PA or CBT+Ex in efficacy. The main objective of this systematic review and meta-analysis of randomized clinical trials (RCTs) was to assess the efficacy of CBT+PA and CBT+Ex interventions in pediatric chronic disease. METHOD: This review included RCTs in children (≤18 years) with a chronic condition, a CBT+Ex or CBT+PA intervention, and an objective measure of PA&Ex. Seven databases were searched using MeSH terms and key terms and included studies published before July 1, 2023. Abstracts were reviewed for inclusion by two independent reviewers, data was extracted by three independent reviewers. Risk of bias (RoB 2) and study quality were coded. Random effect meta-analyses of differences in between-group change in PA&Ex were conducted. RESULTS: Eligible studies (k = 5) reported outcomes for a combined 446 children. A small, nonsignificant overall effect was found (d = 0.10, 95% CI -0.16, 0.35) indicating intervention groups (CBT+PA or CBT+Ex) increased engagement in PA&Ex more than comparator groups (CBT). Additional analyses were inconclusive due to the small number of eligible studies. DISCUSSION: Additional RCTs are needed with integrated PA&Ex interventions targeting pediatric chronic disease. Future trials should report more detailed PA&Ex data. The full protocol for this analysis was prospectively registered in Open Science Framework (project ID: osf.io/m4wtc).

Topic(s):
Healthcare Disparities See topic collection
88
Telephone counseling for physical activity and diet in primary care patients
Type: Journal Article
Authors: E. Eakin, M. Reeves, S. Lawler, N. Graves, B. Oldenburg, C. Del Mar, K. Wilke, E. Winkler, A. Barnett
Year: 2009
Publication Place: Netherlands
Abstract: BACKGROUND: The delivery of effective interventions to assist patients to improve their physical activity and dietary behaviors is a challenge in the busy primary care setting. DESIGN: Cluster RCT with practices randomized to telephone counseling intervention or usual care. Data collection took place from February 2005 to November 2007, with analysis from December 2007 to April 2008. SETTING/PARTICIPANTS: Four-hundred thirty-four adult patients with type 2 diabetes or hypertension (mean age=58.2 [SD=11.8]; 61% female; mean BMI=31.1 [SD=6.8]) from a disadvantaged community were recruited from ten primary care practices. INTERVENTION: Twelve-month telephone counseling intervention. MAIN OUTCOME MEASURES: Physical activity and dietary intake were assessed by self-report at baseline, 4, and 12 months. RESULTS: At 12 months, patients in both groups increased moderate-to-vigorous physical activity by a mean of 78 minutes per week (SE=10). Significant intervention effects (telephone counseling minus usual care) were observed for: calories from total fat (decrease of 1.17%; p<0.007), energy from saturated fat (decrease of 0.97%; p<0.007), vegetable intake (increase of 0.71 servings; p<0.039), fruit intake (increase of 0.30 servings; p<0.001), and grams of fiber (increase of 2.23 g; p<0.001). CONCLUSIONS: The study targeted a challenging primary care patient sample and, using a telephone-delivered intervention, demonstrated modest improvements in diet and in physical activity. Results suggest that telephone counseling is a feasible means of delivering lifestyle intervention to primary care patients with chronic conditions-patients whose need for ongoing support for lifestyle change is often beyond the capacity of primary healthcare practitioners.
Topic(s):
HIT & Telehealth See topic collection
89
Telephone delivered incentives for encouraging adherence to supervised methadone consumption (TIES): Study protocol for a feasibility study for an RCT of clinical and cost effectiveness
Type: Journal Article
Authors: N. Metrebian, T. Weaver, S. Pilling, K. Goldsmith, E. Carr, J. Shearer, K. Woolston-Thomas, B. Tas, C. A. Getty, C. Cooper, R. van der Waal, M. Kelleher, E. Finch, P. Bijral, D. Taylor, J. Scott, J. Strang
Year: 2019
Topic(s):
Education & Workforce See topic collection
,
Financing & Sustainability See topic collection
,
HIT & Telehealth See topic collection
,
Opioids & Substance Use See topic collection
90
The DIAMONDS intervention for type 2 diabetes for people with severe mental illness: findings from a single-group feasibility study
Type: Journal Article
Authors: J. V. E. Brown, C. Carswell, D. Podmore, I. Featherstone, S. Alderson, J. R. Böhnke, T. Doran, M. Hadjiconstantinou, C. E. Hewitt, R. I. G. Holt, R. Jacobs, V. Johnson, I. Kellar, J. Li, D. P. Osborn, G. Russell, J. Watson, N. Siddiqi, P. A. Coventry
Year: 2025
Abstract:

Diabetes self-management is critical for improving health outcomes, but people with severe mental illness (SMI) face additional barriers that complicate effective engagement with self-management behaviours and with existing diabetes services. This feasibility study assessed the acceptability and feasibility of the DIAMONDS intervention, a tailored type 2 diabetes (T2D) self-management programme designed for people with SMI and delivered by trained coaches over 16 weekly sessions, in preparation for a future randomised controlled trial (RCT). Thirty participants with both T2D and SMI were recruited, and 29 were included in the study. The thresholds for participant recruitment and retention for progression to the RCT were met. Twenty-three participants (66%) attended at least one intervention session. Consistent weekly participation proved challenging, with only 15 participants (52%) attending eight or more (50%+) sessions. However, the intervention was acceptable to both participants and coaches, as indicated by coach session logs. High completion rates were observed for self-reported measures, while physical health data and data from primary care records had some omissions, prompting refinements in data collection for the RCT. This study highlights the feasibility and acceptability of delivering an evaluation of a structured diabetes self-management intervention in people with SMI. Some modifications to study processes will be required before moving to the main RCT, including adjustments to intervention delivery (including more flexibility in the timing of intervention sessions and coach training to improve confidence in supporting the use of a mobile app), data collection processes, and intervention fidelity assessment for the RCT, to enhance adherence and accommodating the complex needs of this population. This study represents an important step towards the development and robust evaluation of a self-management intervention to improve diabetes outcomes for people with SMI, addressing a significant gap in health equity. CLINICAL TRIAL REGISTRATION: https://www.isrctn.com/ISRCTN15328700, ISRCTN 15328700.

Topic(s):
Healthcare Disparities See topic collection
91
The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials
Type: Journal Article
Authors: V. Patel, B. Weobong, A. Nadkarni, H. A. Weiss, A. Anand, S. Naik, B. Bhat, J. Pereira, R. Araya, S. Dimidjian, S. D. Hollon, M. King, J. McCambridge, D. McDaid, P. Murthy, R. Velleman, C. G. Fairburn, B. Kirkwood
Year: 2014
Publication Place: England
Abstract: BACKGROUND: The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India. METHODS/DESIGN: This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat. DISCUSSION: These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors. TRIAL REGISTRATION: Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238).
Topic(s):
Financing & Sustainability See topic collection
92
The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS) - A randomised control trial protocol
Type: Journal Article
Authors: S. Coulton, J. Watson, M. Bland, C. Drummond, E. Kaner, C. Godfrey, A. Hassey, V. Morton, S. Parrott, T. Phillips, D. Raistrick, D. Rumball, G. Tober
Year: 2008
Publication Place: England
Abstract: BACKGROUND: There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption. In older populations excessive alcohol consumption is associated with increased risk of coronary heart disease, hypertension, stroke and a range of cancers. Alcohol consumption is also associated with an increased risk of falls, early onset of dementia and other cognitive deficits. Physiological changes that occur as part of the ageing process mean that older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol consumption in populations identified opportunistically in primary care settings. Stepped care interventions involve the delivery of more intensive interventions only to those in the population who fail to respond to less intensive interventions and provide a potentially resource efficient means of meeting the needs of this population. METHODS/DESIGN: The study design is a pragmatic prospective multi-centre two arm randomised controlled trial. The primary hypothesis is that stepped care interventions for older hazardous alcohol users reduce alcohol consumption compared with a minimal intervention at 12 months post randomisation. Potential participants are identified using the AUDIT questionnaire. Eligible and consenting participants are randomised with equal probability to either a minimal intervention or a three step treatment approach. The step treatment approach incorporates as step 1 behavioural change counselling, step 2 three sessions of motivational enhancement therapy and step 3 referral to specialist services. The primary outcome is measured using average standard drinks per day and secondary outcome measures include the Drinking Problems Index, health related quality of life and health utility. The study incorporates a comprehensive economic analysis to assess the relative cost-effectiveness of the interventions. DISCUSSION: The paper presents a protocol for the first pragmatic randomised controlled trial evaluating the effectiveness and cost-effectiveness of stepped care interventions for older hazardous alcohol users in primary care. TRIAL REGISTRATION: ISRCTN52557360.
Topic(s):
Financing & Sustainability See topic collection
93
The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings
Type: Journal Article
Authors: T. A. Moore Simas, L. Brenckle, P. Sankaran, G. A. Masters, S. Person, L. Weinreb, J . Y. Ko, C. L. Robbins, J. Allison, N. Byatt
Year: 2019
Publication Place: England
Abstract:

BACKGROUND: Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support. METHODS: This study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm. DISCUSSION: This manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.

Topic(s):
Education & Workforce See topic collection
,
Healthcare Disparities See topic collection
94
The Substance Use Treatment and Recovery Team (START) study: Protocol for a multi-site RCT evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder
Type: Journal Article
Authors: Allison J. Ober, Cristina Murray-Krezan, Kimberly Page, Peter D. Friedmann, Karen Chan Osilla, Stephen Ryzewicz, Sergio Huerta, Mia W. Mazer, Isabel Leamon, Gabrielle Messineo, Katherine E. Watkins, Teryl Nuckols, Itai Danovitch
Year: 2022
Topic(s):
Healthcare Disparities See topic collection
95
There are no randomized controlled trials that support the United States Preventive Services Task Force Guideline on screening for depression in primary care: a systematic review
Type: Journal Article
Authors: B. D. Thombs, R. C. Ziegelstein, M. Roseman, L. A. Kloda, J. P. Ioannidis
Year: 2014
Publication Place: England
Abstract: BACKGROUND: The United States Preventive Services Task Force (USPSTF) recommends screening adults for depression in primary care settings when staff-assisted depression management programs are available. This recommendation, however, is based on evidence from depression management programs conducted with patients already identified as depressed, even though screening is intended to identify depressed patients not already recognized or treated. The objective of this systematic review was to evaluate whether there is evidence from randomized controlled trials (RCTs) that depression screening benefits patients in primary care, using an explicit definition of screening. METHODS: We re-evaluated RCTs included in the 2009 USPSTF evidence review on depression screening, including only trials that compared depression outcomes between screened and non-screened patients and met the following three criteria: determined patient eligibility and randomized prior to screening; excluded patients already diagnosed with a recent episode of depression or already being treated for depression; and provided the same level of depression treatment services to patients identified as depressed in the screening and non-screening trial arms. We also reviewed studies included in a recent Cochrane systematic review, but not the USPSTF review; conducted a focused search to update the USPSTF review; and reviewed trial registries. RESULTS: Of the nine RCTs included in the USPSTF review, four fulfilled none of three criteria for a test of depression screening, four fulfilled one of three criteria, and one fulfilled two of three criteria. There were two additional RCTs included only in the Cochrane review, and each fulfilled one of three criteria. No eligible RCTs were found via the updated review. CONCLUSIONS: The USPSTF recommendation to screen adults for depression in primary care settings when staff-assisted depression management programs are available is not supported by evidence from any RCTs that are directly relevant to the recommendation. The USPSTF should re-evaluate this recommendation. Please see related article: http://www.biomedcentral.com/1741-7015/12/14 REGISTRATION: PROSPERO (#CRD42013004276).
Topic(s):
Key & Foundational See topic collection
96
Training practitioners to deliver opportunistic multiple behaviour change counselling in primary care: a cluster randomised trial
Type: Journal Article
Authors: C. C. Butler, S. A. Simpson, K. Hood, D. Cohen, T. Pickles, C. Spanou, J. McCambridge, L. Moore, E. Randell, M. F. Alam, P. Kinnersley, A. Edwards, C. Smith, S. Rollnick
Year: 2013
Publication Place: England
Abstract: OBJECTIVES: To evaluate the effect of training primary care health professionals in behaviour change counselling on the proportion of patients self reporting change in four risk behaviours (smoking, alcohol use, exercise, and healthy eating). DESIGN: Cluster randomised trial with general practices as the unit of randomisation. SETTING: General practices in Wales. PARTICIPANTS: 53 general practitioners and practice nurses from 27 general practices (one each at all but one practice) recruited 1827 patients who screened positive for at least one risky behaviour. INTERVENTION: Behaviour change counselling was developed from motivational interviewing to enable clinicians to enhance patients' motivation to change health related behaviour. Clinicians were trained using a blended learning programme called Talking Lifestyles. MAIN OUTCOME MEASURES : Proportion of patients who reported making beneficial changes in at least one of the four risky behaviours at three months. RESULTS: 1308 patients from 13 intervention and 1496 from 14 control practices were approached: 76% and 72% respectively agreed to participate, with 831 (84%) and 996 (92%) respectively screening eligible for an intervention. There was no effect on the primary outcome (beneficial change in behaviour) at three months (362 (44%) v 404 (41%), odds ratio 1.12 (95% CI 0.90 to 1.39)) or on biochemical or biometric measures at 12 months. More patients who had consulted with trained clinicians recalled consultation discussion about a health behaviour (724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to 26.46)) and intended to change (599/831 (72%) v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More intervention practice patients reported making an attempt to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to 1.70)), a sustained behaviour change at three months (288 (35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and reported slightly greater improvements in healthy eating at three and 12 months, plus improved activity at 12 months. Training cost pound1597 per practice. DISCUSSION: Training primary care clinicians in behaviour change counselling using a brief blended learning programme did not increase patients reported beneficial behaviour change at three months or improve biometric and a biochemical measure at 12 months, but it did increase patients' recollection of discussing behaviour change with their clinicians, intentions to change, attempts to change, and perceptions of having made a lasting change at three months. Enduring behaviour change and improvements in biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling without additional intervention. TRIAL REGISTRATION: ISRCTN 22495456.
Topic(s):
Education & Workforce See topic collection
98
Understanding Supporting and Hindering Factors in Community-Based Psychotherapy for Refugees: A Realist-Informed Systematic Review
Type: Journal Article
Authors: D. Gruner, O. Magwood, L. Bair, L. Duff, S. Adel, K. Pottie
Year: 2020
Abstract:

Culture, tradition, structural violence, and mental health-related stigma play a major role in global mental health for refugees. Our aim was to understand what factors determine the success or failure of community-based psychotherapy for trauma-affected refugees and discuss implications for primary health care programs. Using a systematic realist-informed approach, we searched five databases from 2000 to 2018. Two reviewers independently selected RCTs for inclusion, and we contacted authors to obtain therapy training manuals. Fifteen articles and 11 training manuals met our inclusion criteria. Factors that improved symptoms of depression, anxiety, and PTSD included providing culturally adapted care in a migrant-sensitive setting, giving a role to other clinical staff (task-shifting), and intervention intensity. Precarious asylum status, constraining program monitoring requirements, and diverse socio-cultural and gender needs within a setting may reduce the effectiveness of the program. Primary care programs may enable community based mental health care and may reduce mental health-related stigma for refugees and other migrants. More research is needed on the cultural constructs of distress, programs delivered in primary care, and the role of cultural and language interpretation services in mental health care.

Topic(s):
Education & Workforce See topic collection
,
Healthcare Disparities See topic collection
99
Unhealthy alcohol use and risk of coronary heart disease among young and middle-aged adults
Type: Journal Article
Authors: J. S. Rana, F. W. Chi, I. Acquah, S. A. Sterling
Year: 2025
Abstract:

OBJECTIVE: To examine the associations between unhealthy alcohol use and risk of coronary heart disease (CHD) among women and men aged 18-65 years. METHODS: An observational study in an integrated healthcare system with systematic alcohol screening. We identified 432,265 primary care patients aged 18-65 years who, in 2014-2015, reported weekly alcohol intake levels. Weekly alcohol intake, categorized into below (≤14/week men; ≤7/week women) and above limits (≥15/week men; ≥ 8/week women) per U.S. guidelines, and heavy episodic drinking (HED, ≥5/≥4 drinks any day in past 3 months for men/women, respectively). Main outcome was CHD during 4-year follow-up, based on inpatient ICD diagnoses of myocardial infarction and CHD. Cox proportional hazards models adjusted for age, sex, race/ethnicity, body mass index, physical activity, smoking, hypertension, diabetes, and hyperlipidemia. RESULTS: The cohort comprised 44 % women, mean age (standard deviation) of 43.5 years (±13.1). Weekly alcohol intake above limits was associated with higher prevalence of cardiovascular risk factors, and a 26 %, 19 % and 43 % higher risk on the overall, men- and women-specific risk of CHD after adjusting for these risk factors (hazard ratio [95 % confidence interval] = 1.26[1.13 -1.40], 1.19[1.04-1.35] and 1.43[1.20-1.71], respectively). CONCLUSIONS: In a large, real-world, diverse population with a systematic alcohol screening program, having weekly alcohol intake above limits was associated with increased risk of CHD among young and middle-aged men and women. Increased CHD risk due to alcohol intake above limits warrants particular awareness and interventions.

Topic(s):
Opioids & Substance Use See topic collection
100
Using quantitative and qualitative data in health services research - what happens when mixed method findings conflict? [ISRCTN61522618]
Type: Journal Article
Authors: S. Moffatt, M. White, J. Mackintosh, D. Howel
Year: 2006
Publication Place: England
Abstract: BACKGROUND: In this methodological paper we document the interpretation of a mixed methods study and outline an approach to dealing with apparent discrepancies between qualitative and quantitative research data in a pilot study evaluating whether welfare rights advice has an impact on health and social outcomes among a population aged 60 and over. METHODS: Quantitative and qualitative data were collected contemporaneously. Quantitative data were collected from 126 men and women aged over 60 within a randomised controlled trial. Participants received a full welfare benefits assessment which successfully identified additional financial and non-financial resources for 60% of them. A range of demographic, health and social outcome measures were assessed at baseline, 6, 12 and 24 month follow up. Qualitative data were collected from a sub-sample of 25 participants purposively selected to take part in individual interviews to examine the perceived impact of welfare rights advice. RESULTS: Separate analysis of the quantitative and qualitative data revealed discrepant findings. The quantitative data showed little evidence of significant differences of a size that would be of practical or clinical interest, suggesting that the intervention had no impact on these outcome measures. The qualitative data suggested wide-ranging impacts, indicating that the intervention had a positive effect. Six ways of further exploring these data were considered: (i) treating the methods as fundamentally different; (ii) exploring the methodological rigour of each component; (iii) exploring dataset comparability; (iv) collecting further data and making further comparisons; (v) exploring the process of the intervention; and (vi) exploring whether the outcomes of the two components match. CONCLUSION: The study demonstrates how using mixed methods can lead to different and sometimes conflicting accounts and, using this six step approach, how such discrepancies can be harnessed to interrogate each dataset more fully. Not only does this enhance the robustness of the study, it may lead to different conclusions from those that would have been drawn through relying on one method alone and demonstrates the value of collecting both types of data within a single study. More widespread use of mixed methods in trials of complex interventions is likely to enhance the overall quality of the evidence base.
Topic(s):
HIT & Telehealth See topic collection