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Clinical Trial
. 2024 Nov 9;12(1):643.
doi: 10.1186/s40359-024-02053-5.

Pilot evaluation on an adapted tele-behavioral activation to increase physical activity in persons with depression: a single-arm pilot study

Affiliations
Clinical Trial

Pilot evaluation on an adapted tele-behavioral activation to increase physical activity in persons with depression: a single-arm pilot study

Chad D Rethorst et al. BMC Psychol. .

Abstract

Background: Physical activity has the potential to improve physical and mental health outcomes of persons with depression. However, feasible and acceptable strategies to integrate physical activity interventions into real-world settings are needed.

Objective: To assess the feasibility and acceptability of a manualized Behavioral Activation intervention aimed to increase physical activity in persons with depression (defined as a PHQ-9 score ≥ 10).

Methods: A single-arm pilot study was conducted. The intervention consisted of 8 tele-therapy sessions delivered over a 10-week period. Measures of feasibility included screening, enrollment, intervention adherence, outcome data availability, and intervention fidelity. Acceptability was assessed with a post-intervention survey and qualitatively through focus groups and interviews. Preliminary efficacy of the intervention was assessed by evaluating pre-to-post changes in physical activity and depressive symptoms.

Results: All feasibility metrics exceeded predetermined feasibility goal metrics with the exception of Fitbit wear and screening rate, which was due to a greater than anticipated enrollment rate. Participants (n = 15) reported perceived benefits from the intervention and convenience in attending tele-therapy sessions. Depressive symptoms, as measured by the PHQ-9 improved (16.8 at enrollment to 10.1 post intervention, Cohen's d = 1.13). Self-reported moderate-to-vigorous physical activity (MVPA) increased from 22.0 min/week at baseline to 36.67 min/week post-intervention (d = 0.58). Physical activity as measured by the Fitbit showed little change (daily step 5543.29 during Week 1 to 6177.48 during Week 10, (d = 0.14); MVPA 21.23 min/week during Week 1 to 19.22 at Week 10 (d = 0.0.06).

Conclusions: Results of the pilot study suggest the intervention is feasible to deliver and acceptable to participants. Preliminary results suggest the intervention may be effective in improving depressive symptoms and increasing self-reported physical activity.

Trial registration: ClinicalTrials.gov NCT04990401, Registered July 21, 2021.

Keywords: Behavioral activation; Depression; Exercise; Physical activity.

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Conflict of interest statement

Joseph Trombello is a shareholder in Merck, unrelated to the current project. Within the past 36 months, Dr. Trivedi has provided consulting services to ACADIA Pharmaceuticals, Allergan, Alkermes Inc., Alto Neuroscience Inc, Applied Clinical Intelligence, LLC, Axsome Therapeutics, Biogen MA Inc, Boegringer Ingelheim, Cerebral Inc., Circular Genomics Inc., Compass Pathfinder Limited, GH Research, GreenLight VitalSign6 Inc, Heading Health, Health Care Global Village, Janssen Pharmaceutical, Jazz Pharmaceutical, Legion Health, Lundbeck Research USA, Merck Sharp & Dohme Corp., Mind Medicine Inc., Myriad Neuroscience, Naki Health Ltd, Navitor, Neurocrine Biosciences Inc., Noema Pharma AG, Orexo US Inc., Otsuka America Pharmaceutical Inc, Perception Neuroscience Holdings, Pharmerit International, Policy Analysis Inc., Praxis Precision Medicines Inc, Rexahn Pharmaceuticals, Inc., SAGE Therapeutics, Signant Health, Sparian Biosciences, Titan Pharmaceuticals, Takeda Pharmaceuticals Inc, WebMD. He has received grant/research funding from NIMH, NIDA, NCATS, American Foundation for Suicide Prevention, Patient-Centered Outcomes Research Institute (PCORI), and Blue Cross Blue Shield of Texas. Additionally, he has received editorial compensation from Engage Health Media, and Oxford University Press. All other authors have no competing interests to report.

Figures

Fig. 1
Fig. 1
Mean PHQ-9 scores by visit
Fig. 2
Fig. 2
Mean number of steps by week
Fig. 3
Fig. 3
Mean MVPA by week

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