Evidence map›Paper›PMID 33952313›Full record

ArticleTrials2021

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).

Markus W Haun, Justus Tönnies, Regina Krisam, Dorothea Kronsteiner, Michel Wensing, Joachim Szecsenyi, Markus Vomhof, Andrea Icks, Beate Wild, Mechthild Hartmann and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04316572 (ImPROving Cross-sectoral Collaboration Between Primary and Psychosocial Care), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04316572 nacompletednot on this map

ImPROving Cross-sectoral Collaboration Between Primary and Psychosocial Care: A Randomised Controlled Superiority Trial to Compare the Effectiveness of a Mental Health Specialist VIDEo Consultations Model Versus Treatment as Usual in Patients With Depression or Anxiety Disorders in Primary Care

TypeinterventionalSponsorHeidelberg UniversityRan2020 to 2022Enrolled376ConditionsDepression, Anxiety DisorderArmsmental health specialist video consultation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Markus W HaunDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany. markus.haun@med.uni-heidelberg.de.ORCID http://orcid.org/0000-0003-1851-3747
Justus TönniesDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.
Regina KrisamInstitute of Medical Biometry and Informatics (IMBI), Heidelberg University, Heidelberg, Germany.
Dorothea KronsteinerInstitute of Medical Biometry and Informatics (IMBI), Heidelberg University, Heidelberg, Germany.
Michel WensingDepartment of General Practice and Health Services Research, Heidelberg University, Heidelberg, Germany.
Joachim SzecsenyiDepartment of General Practice and Health Services Research, Heidelberg University, Heidelberg, Germany.
Markus VomhofInstitute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine-University, Düsseldorf, Germany.
Andrea IcksInstitute for Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich-Heine-University, Düsseldorf, Germany.
Beate WildDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.
Mechthild HartmannDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.
Hans-Christoph FriederichDepartment of General Internal Medicine and Psychosomatics, Heidelberg University, Im Neuenheimer Feld 410, D-69120, Heidelberg, Germany.
Heidelberg University · DEDeutsches Diabetes-Zentrum e.V. · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost 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.

methodsIn 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 registrationClinicalTrials.gov, United States National Institutes of Health NCT04316572 . Prospectively registered on 20 March 2020.

Indexed as

Anxiety DisordersDepressionMental HealthPrimary Health CareTelemedicineCost-Benefit AnalysisEquivalence Trials as TopicGermanyHumansProspective StudiesSpecializationTreatment OutcomeAnxietyDepressionIntegrated carePrimary careRandomised controlled trialTelepsychiatryVideoconferencing

Identifiers

PMID33952313
PMCPMC8097128
OpenAlexW3134442060

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.