Evidence map›Paper›PMID 32295779›Full record

ArticleBMJ open2020

STEP.De study-a multicentre cluster-randomised effectiveness trial of exercise therapy for patients with depressive symptoms in healthcare services: study protocol.

Andreas Heissel, Anou Pietrek, Melanie Schwefel, Kahar Abula, Gregor Wilbertz, Stephan Heinzel, Michael Rapp

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 24% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

7 authors at 2 institutions in 1 country.

Andreas HeisselSocial and Preventive Medicine, Department Sport and Health Sciences, Faculty of Human Sciences, University of Potsdam, Potsdam, Brandenburg, Germany andreas.heissel@uni-potsdam.de.ORCID 0000-0001-9270-7027
Anou PietrekSocial and Preventive Medicine, Department Sport and Health Sciences, Faculty of Human Sciences, University of Potsdam, Potsdam, Brandenburg, Germany.
Melanie SchwefelSocial and Preventive Medicine, Department Sport and Health Sciences, Faculty of Human Sciences, University of Potsdam, Potsdam, Brandenburg, Germany.
Kahar AbulaSocial and Preventive Medicine, Department Sport and Health Sciences, Faculty of Human Sciences, University of Potsdam, Potsdam, Brandenburg, Germany.
Gregor WilbertzDepartment of Education and Psychology, Freie Universität Berlin, Berlin, Germany.
Stephan HeinzelDepartment of Education and Psychology, Freie Universität Berlin, Berlin, Germany.
Michael RappSocial and Preventive Medicine, Department Sport and Health Sciences, Faculty of Human Sciences, University of Potsdam, Potsdam, Brandenburg, Germany.
University of Potsdam · DEFreie Universität Berlin · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAlthough exercise therapy has widely been shown to be an efficacious treatment modality for depression, evidence for its effectiveness and cost efficiency is lacking. The Sport/Exercise Therapy for Depression study is a multicentre cluster-randomised effectiveness trial that aims to compare the effectiveness and cost efficiency of exercise therapy and psychotherapy as antidepressant treatment. METHODS AND ANALYSIS: 480 patients (aged 18-65) with an International Classification of Diseases diagnosis associated with depressive symptoms are recruited. Up to 30 clusters (psychotherapists) are randomly assigned to allocate patients to either an exercise or a psychotherapy treatment as usual in a 2:1 ratio. The primary outcome (depressive symptoms) and the secondary outcomes (work and social adjustment, quality of life) will be assessed at six measurement time points (t0: baseline, t1: 8 weeks after treatment initiation, t2: 16 weeks after treatment initiation, t3/4/5: 2, 6, 12 months after treatment). Linear regression analyses will be used for the primary endpoint data analysis. For the secondary endpoints, mixed linear and logistic regression models with fixed and random factors will be added. For the cost efficiency analysis, expenditures in the 12 months before and after the intervention and the outcome difference will be compared between groups in a multilevel model. Recruitment start date was 1 July 2018 and the planned recruitment end date is 31 December 2020. ETHICS AND DISSEMINATION: The study protocol was approved by the ethics committee of the University of Potsdam (No. 17/2018) and the Freie Universität Berlin (No. 206/2018) and registered in the ISRCTN registry. Informed written consent will be obtained from all participants. The study will be reported in accordance with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials statements. The results will be published in peer-reviewed academic journals and disseminated to the public. TRIAL REGISTRATION NUMBER: ISRCTN28972230.

Indexed as

DepressionExercise TherapyAdolescentAdultAgedBerlinFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPsychotherapyQuality of LifeRandomized Controlled Trials as TopicSocial AdjustmentYoung Adultdepression & mood disordershealth economicsmental healthpublic health

Identifiers

PMID32295779
PMCPMC7200038
OpenAlexW3016482993

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.