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Open Access 01-12-2023 | Care | Study protocol

Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders—the ImPuls study

Authors: David Victor Fiedler, Stephanie Rosenstiel, Johanna-Marie Zeibig, Britta Seiffer, Jana Welkerling, Anna Katharina Frei, Thomas Studnitz, Julia Baur, Florian Helmhold, Andreas Ray, Eva Herzog, Keisuke Takano, Tristan Nakagawa, Saskia Kropp, Sebastian Franke, Stefan Peters, Anna Lena Flagmeier, Lena Zwanzleitner, Leonie Sundmacher, Ander Ramos-Murguialday, Martin Hautzinger, Thomas Ehring, Gorden Sudeck, Sebastian Wolf

Published in: Trials | Issue 1/2023

Abstract

Background

Evidence suggests that patients suffering from different mental disorders benefit from exercise programs combined with behavior change techniques. Based on this evidence, we have developed an exercise program (ImPuls) specifically designed to provide an additional treatment option in the outpatient mental health care system. The implementation of such complex programs into the outpatient context requires research that goes beyond the evaluation of effectiveness, and includes process evaluation. So far, process evaluation related to exercise interventions has rarely been conducted. As part of a current pragmatic randomized controlled trial evaluating ImPuls treatment effects, we are therefore carrying out comprehensive process evaluation according to the Medical Research Council (MRC) framework. The central aim of our process evaluation is to support the findings of the ongoing randomized controlled trial.

Methods

The process evaluation follows a mixed-methods approach. We collect quantitative data via online-questionnaires from patients, exercise therapists, referring healthcare professionals and managers of outpatient rehabilitative and medical care facilities before, during, and after the intervention. In addition, documentation data as well as data from the ImPuls smartphone application are collected. Quantitative data is complemented by qualitative interviews with exercise therapists as well as a focus-group interview with managers. Treatment fidelity will be assessed through the rating of video-recorded sessions. Quantitative data analysis includes descriptive as well as mediation and moderation analyses. Qualitative data will be analyzed via qualitative content analysis.

Discussion

The results of our process evaluation will complement the evaluation of effectiveness and cost-effectiveness and will, for example, provide important information about mechanisms of impact, structural prerequisites, or provider qualification that may support the decision-making process of health policy stakeholders. It might contribute to paving the way for exercise programs like ImPuls to be made successively available for patients with heterogeneous mental disorders in the German outpatient mental health care system.

Trial registration

The parent clinical study was registered in the German Clinical Trials Register (ID: DRKS00024152, registered 05/02/2021, https://drks.de/search/en/trial/DRKS00024152).

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Title: Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders—the ImPuls study
Authors: David Victor Fiedler
Stephanie Rosenstiel
Johanna-Marie Zeibig
Britta Seiffer
Jana Welkerling
Anna Katharina Frei
Thomas Studnitz
Julia Baur
Florian Helmhold
Andreas Ray
Eva Herzog
Keisuke Takano
Tristan Nakagawa
Saskia Kropp
Sebastian Franke
Stefan Peters
Anna Lena Flagmeier
Lena Zwanzleitner
Leonie Sundmacher
Ander Ramos-Murguialday
Martin Hautzinger
Thomas Ehring
Gorden Sudeck
Sebastian Wolf
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Care
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07331-y

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Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders—the ImPuls study

Abstract

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Springer Medicine

Abstract

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Other articles of this Issue 1/2023

What is the role of randomised trials in implementation science?

Correction: An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study

Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial

Principle-Guided Psychotherapy for Children and Adolescents (FIRST): study protocol for a randomized controlled effectiveness trial in outpatient clinics

Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial

The IBD-FITT study — moderate-intensity exercise for patients with inflammatory bowel disease with moderate disease activity: an open-label randomized controlled trial