TY - JOUR
KW - Anxiety Disorders/diagnosis/therapy
KW - Cost-Benefit Analysis
KW - Depression/diagnosis/therapy
KW - Germany
KW - Humans
KW - Mental Health
KW - Primary Health Care
KW - Prospective Studies
KW - Specialization
KW - Telemedicine
KW - Treatment Outcome
KW - Anxiety
KW - Depression
KW - integrated care
KW - primary care
KW - Randomised controlled trial
KW - Telepsychiatry
KW - Videoconferencing
AU - M. W. Haun
AU - J. Tonnies
AU - R. Krisam
AU - D. Kronsteiner
AU - M. Wensing
AU - J. Szecsenyi
AU - M. Vomhof
AU - A. Icks
AU - B. Wild
AU - M. Hartmann
AU - H. C. Friederich
A1 - 
AB - BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. METHODS: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. DISCUSSION: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. TRIAL REGISTRATION: ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.
AD - Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany. markus.haun@med.uni-heidelberg.de.; Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.; Institute of Medical Biometry and Informatics (IMBI), Heidelberg University, Heidelberg, Germany.; Institute of Medical Biometry and Informatics (IMBI), Heidelberg University, Heidelberg, Germany.; Department of General Practice and Health Services Research, Heidelberg University, Heidelberg, Germany.; Department of General Practice and Health Services Research, Heidelberg University, Heidelberg, Germany.; Institute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine-University, Düsseldorf, Germany.; Institute for Health Services Research and Health Economics, German Diabetes Centre, Düsseldorf, Germany.; Institute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine-University, Düsseldorf, Germany.; Institute for Health Services Research and Health Economics, German Diabetes Centre, Düsseldorf, Germany.; Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.; Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.; Department of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.
BT - Trials
C5 - Financing & Sustainability; HIT & Telehealth; Measures
CP - 1
DO - 10.1186/s13063-021-05289-3
IS - 1
JF - Trials
LA - eng
M1 - Journal Article
N2 - BACKGROUND: Most people with mental disorders, including those with severe and chronic disorders, are treated solely by their general practitioner (GP). Nevertheless, specialised mental health care may be required for specific patients. Notably, the accessibility of mental health specialist care is mainly complicated by (a) long waiting times for an appointment with specialists, (b) long travel distances to specialists, particularly in rural and remote areas, and (c) patients' reservations about mental health specialist care (including fear of being stigmatised by seeking such care). To mitigate those barriers, technology-based integrated care models have been proposed. The purpose of this study is to examine the effectiveness and cost-effectiveness of a mental health specialist video consultations model versus treatment as usual in patients with depression or anxiety disorders in primary care. METHODS: In an individually randomised, prospective, two-arm superiority trial with parallel group design, N = 320 patients with anxiety and/or depressive disorder will be recruited in general practices in Germany. The intervention includes a newly developed treatment model based on video consultations with focus on diagnostics, treatment planning, and short-term intervention by mental health specialists. We will systematically compare the effectiveness, cost-effectiveness, and adverse effects of this new model with usual care by the GP: the primary outcome is the absolute change in the mean depressive and anxiety symptom severity measured on the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) from baseline to 6 months after baseline assessment. Follow-up in both groups will be conducted by blinded outcome assessors at 6 months and 12 months after baseline. The main analysis will be based on the intention-to-treat principle. We will optimise the likelihood of treatment effectiveness by strict inclusion criteria for patients, enhanced intervention integrity, and conducting a process evaluation. DISCUSSION: To the best of our knowledge, this is the first confirmatory study on a video-based, integrated care model for the treatment of anxiety and depressive disorders in GP patients in Germany. TRIAL REGISTRATION: ClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.
PY - 2021
SN - 1745-6215; 1745-6215
SP - 327
T1 - Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: Study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
T2 - Trials
TI - Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: Study protocol for an individually randomised superiority trial (the PROVIDE-C trial)
U1 - Financing & Sustainability; HIT & Telehealth; Measures
U2 - 33952313
U3 - 10.1186/s13063-021-05289-3
VL - 22
VO - 1745-6215; 1745-6215
Y1 - 2021
Y2 - May 5
ER -