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Annals of General Psychiatry
Published in: Annals of General Psychiatry 1/2018

Open Access 01-12-2018 | Primary research

EFFORT-D study process evaluation: challenges in conducting a trial into the effects of running therapy in patients with major depressive disorder

Authors: Frank Kruisdijk, Ingrid Hendriksen, Erwin Tak, Aart-Jan Beekman, Marijke Hopman-Rock

Published in: Annals of General Psychiatry | Issue 1/2018

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Abstract

Background

Exercise is currently seen as an effective treatment for major depressive disorder (MDD). However, existing studies have focused mainly on mild-to-moderate depression. The moderate positive effect of exercise found in meta-analyses concerning these studies differs, however, from the harsh daily clinical practice, when trying to implement exercise as an adjunctive treatment. We aimed to evaluate the feasibility of aerobic exercise in MDD and identify future problems for implementation.

Methods

The EFFect Of Running Therapy on Depression (EFFORT-D) study was a randomized clinical trial examining the effectiveness of running therapy or Nordic walking in inpatients and outpatients with MDD. We conducted a process evaluation based on the method of Linnan and Steckler. Participant inclusion, dropout and no show were registered qualitatively and quantitatively.

Results

The inclusion and delivered dose of the exercise interventions were limited (60 and 75%, respectively), leading to 80% less inclusion than foreseen. Motivational doubts were the main reason not to participate in the study. The unexpected high dropout rates (40% after 3 months and 80% after 12 months) were frequently related to lack of motivation due to disease characteristics and severity. The duration of the intervention, longer than 3 months was another underlying factor for poor adherence.

Conclusions

Depression severity appeared to be the key factor determining dropout, followed by the duration of exercise intervention, expressed by a pre- and post-inclusion lack of motivation. Both running therapy and Nordic walking were apparently unsuitable for most patients with MDD in the current format. Emphasis on motivational issues is necessary from the early start of the intervention in these patients with MDD. Also a tailored and stepped-care approach is advised for future implementation.
Trial registration The randomized controlled trial protocol of EFFORT-D was approved by the Medical Ethical Committee for Mental Health (Metigg Kamer Noord), CCMO (Central Committee on Research Involving Human Subjects) Protocol Number: NL.26169.097.08. Registration in the Netherlands Trial Register (NTR): NTR1894 on July 2, 2009
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Metadata
Title
EFFORT-D study process evaluation: challenges in conducting a trial into the effects of running therapy in patients with major depressive disorder
Authors
Frank Kruisdijk
Ingrid Hendriksen
Erwin Tak
Aart-Jan Beekman
Marijke Hopman-Rock
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Annals of General Psychiatry / Issue 1/2018
Electronic ISSN: 1744-859X
DOI
https://doi.org/10.1186/s12991-018-0181-7

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