Evidence map›Paper›PMID 34717567›Full record

ArticleBMC psychiatry2021

Efficacy and cost-effectiveness of a Transdiagnostic group-based exercise intervention: study protocol for a pragmatic multi-site randomized controlled trial.

Sebastian Wolf, Britta Seiffer, Johanna-Marie Zeibig, Jana Welkerling, Leonie Louisa Bauer, Anna Katharina Frei, Thomas Studnitz, Stephanie Rosenstiel, David Victor Fiedler, Florian Helmhold and 14 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
2.0field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. [DNVF Memorandum: Objectives and Methods of Physical Activity-Related Health Services Research].Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) · 2024
    Article
  7. Article
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

24 authors at 6 institutions in 1 country.

Sebastian WolfFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany. sebastian.wolf@uni-tuebingen.de.ORCID 0000-0001-8238-5861
Britta SeifferFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Johanna-Marie ZeibigFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Jana WelkerlingFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Leonie Louisa BauerFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Anna Katharina FreiFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Thomas StudnitzFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Stephanie RosenstielFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
David Victor FiedlerFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Florian HelmholdMedical Faculty, Institute of Medical Psychology and Behavioral Neurobiology, University of Tuebingen, Tuebingen, Germany.
Andreas RayMedical Faculty, Institute of Medical Psychology and Behavioral Neurobiology, University of Tuebingen, Tuebingen, Germany.
Eva HerzogDepartment of Psychology, Clinical Psychology and Psychotherapy, LMU Munich, Munich, Germany.
Keisuke TakanoDepartment of Psychology, Clinical Psychology and Psychotherapy, LMU Munich, Munich, Germany.
Tristan NakagawaDepartment of Psychology, Clinical Psychology and Psychotherapy, LMU Munich, Munich, Germany.
Saskia KroppChair of Health Economics, Technical University Munich (TUM), Munich, Germany.
Sebastian FrankeChair of Health Economics, Technical University Munich (TUM), Munich, Germany.
Stefan PetersGerman Association for health-related Fitness and Exercise Therapy (German: DVGS), Hürth-Efferen, Germany.
Nadja El-KurdAOK Baden-Wuerttemberg, Stuttgart, Germany.
Lena ZwanzleitnerTechniker Krankenkasse, Hamburg, Germany.
Leonie SundmacherChair of Health Economics, Technical University Munich (TUM), Munich, Germany.
Ander Ramos-MurguialdayMedical Faculty, Institute of Medical Psychology and Behavioral Neurobiology, University of Tuebingen, Tuebingen, Germany.
Martin HautzingerFaculty of Science, Department of Clinical Psychology and Psychotherapy, Psychological Institute, University of Tuebingen, Tuebingen, Germany.
Gorden SudeckFaculty of Economics and Social Sciences, Department of Education & Health Research, Institute of Sports Science, University of Tuebingen, Tuebingen, Germany.
Thomas EhringDepartment of Psychology, Clinical Psychology and Psychotherapy, LMU Munich, Munich, Germany.
University of Tübingen · DELMU Klinikum · DETechnical University of Munich · DEAOK · DEGerman Insurance Association · DETechniker Krankenkasse (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMental disorders are prevalent and cause considerable burden of disease. Exercise has been shown to be efficacious to treat major depressive disorders, insomnia, panic disorder with and without agoraphobia and post traumatic stress disorder (PTSD).

methodsThis pragmatic, two arm, multi-site randomised controlled trial will evaluate the efficacy and cost-effectiveness of the manualized, group-based six-months exercise intervention "ImPuls", among physically inactive patients with major depressive disorders, insomnia, panic disorder, agoraphobia and PTSD within a naturalistic outpatient context in Germany. A minimum of 375 eligible outpatients from 10 different study sites will be block-randomized to either ImPuls in addition to treatment as usual (TAU) or TAU only. ImPuls will be conducted by trained exercise therapists and delivered in groups of six patients. The program will combine (a) moderate to vigorous aerobic exercise carried out two-three times a week for at least 30 min with (b) behavior change techniques for sustained exercise behavior change. All outcomes will be assessed pre-treatment, post-treatment (six months after randomization) and at follow-up (12 months after randomization). Primary outcome will be self-reported global symptom severity assessed with the Brief Symptom Inventory (BSI-18). Secondary outcomes will be accelerometry-based moderate to vigorous physical activity, self-reported exercise, disorder-specific symptoms, quality-adjusted life years (QALY) and healthcare costs. Intention-to-treat analyses will be conducted using mixed models. Cost-effectiveness and cost-utility analysis will be conducted using incremental cost-effectiveness and cost-utility ratios. DISCUSSION: Despite its promising therapeutic effects, exercise programs are currently not provided within the outpatient mental health care system in Germany. This trial will inform service providers and policy makers about the efficacy and cost-effectiveness of the group-based exercise intervention ImPuls within a naturalistic outpatient health care setting. Group-based exercise interventions might provide an option to close the treatment gap within outpatient mental health care settings.

trial registrationThe study was registered in the German Clinical Trials Register (ID: DRKS00024152 , 05/02/2021).

Indexed as

Major Depressive DisorderAgoraphobiaCost-Benefit AnalysisExercise TherapyHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality-Adjusted Life YearsRandomized Controlled Trials as TopicDepressionExerciseExercise therapyHealth economicsInsomniaMental disordersMental healthOutpatient carePanic disorderPTSD

Identifiers

PMID34717567
PMCPMC8556805
OpenAlexW3209574292

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.