Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial)

Jacob D Meyer; Shania J E Kelly; John M Gidley; Jeni E Lansing; Seana L Smith; Sydney L Churchill; Emily B K Thomas; Simon B Goldberg; Heather C Abercrombie; Thomas A Murray; Nathaniel G Wade

doi:10.1186/s13063-024-08495-x

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Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial)

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Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial)

Jacob D Meyer, Shania J E Kelly, John M Gidley, Jeni E Lansing, Seana L Smith, Sydney L Churchill, Emily B K Thomas, Simon B Goldberg, Heather C Abercrombie, Thomas A Murray, …

Trials, Vol.25(1), 663

10/07/2024

DOI: 10.1186/s13063-024-08495-x

PMCID: PMC11460085

PMID: 39375728

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Abstract

Depression is a leading cause of disability worldwide, and treatments could be more effective. Identifying methods to improve treatment success has the potential to reduce disease burden dramatically. Preparing or "priming" someone to respond more effectively to psychotherapy (e.g., cognitive behavioral therapy [CBT]) by preceding sessions with aerobic exercise, a powerful neurobiological activator, could enhance the success of the subsequently performed therapy. However, the success of this priming approach for increasing engagement of working mechanisms of psychotherapy (e.g., increased working alliance and behavioral activation) has yet to be formally tested. The CBT + trial will be a parallel-arm randomized controlled trial that will recruit 40 adult participants with DSM-5 diagnosed depression (verified with clinical interview) via referrals, mass emails, local flyers, and social media posts. Participants will be randomized to an ActiveCBT or CalmCBT condition. The ActiveCBT group will receive an 8-week CBT intervention primed with 30 min of moderate-intensity aerobic exercise (cycling on a stationary bike at a 13 rating of perceived exertion). The CalmCBT group will receive the same 8-week CBT intervention while resting for 30 min before CBT (i.e., cycling vs no cycling is the only difference). The primary outcome measures will be mean working alliance (assessed with the client version of the Working Alliance Inventory-Short Revised) and mean behavioral activation (self-reported Behavioral Activation for Depression Scale) recorded at each of the 8 therapy sessions. Secondary outcomes include evaluation of state anhedonia and serum brain-derived neurotrophic factor before the active/calm conditions, between the condition and therapy, and after the therapy. Additional exploratory analyses will evaluate group differences in algorithm-generated ratings of therapist-participant interactions via the Lyssn platform. The novel approach of priming CBT with moderate-intensity aerobic exercise evaluated in a randomized controlled trial (CBT + trial) has the potential to demonstrate the usefulness of exercise as an augmentation strategy that improves working mechanisms of therapy and overall treatment outcomes for adults with depression. ClinicalTrials.gov NCT06001346 . Registered on August 21, 2023.

Exercise

Adult

Brain-Derived Neurotrophic Factor - blood

Cognitive Behavioral Therapy - methods

Depression - diagnosis

Depression - psychology

Depression - therapy

Exercise Therapy - methods

Female

Humans

Male

Middle Aged

Randomized Controlled Trials as Topic

Time Factors

Treatment Outcome

Young Adult

Details

Title: Subtitle: Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial)
Creators: Jacob D Meyer - Iowa State University
Shania J E Kelly - Iowa State University
John M Gidley - Iowa State University
Jeni E Lansing - Iowa State University
Seana L Smith - Iowa State University
Sydney L Churchill - Iowa State University
Emily B K Thomas - University of Iowa
Simon B Goldberg - University of Wisconsin–Madison
Heather C Abercrombie - University of Wisconsin–Madison
Thomas A Murray - University of Minnesota
Nathaniel G Wade - Iowa State University
Resource Type: Journal article
Publication Details: Trials, Vol.25(1), 663
DOI: 10.1186/s13063-024-08495-x
PMID: 39375728
PMCID: PMC11460085
NLM abbreviation: Trials
ISSN: 1745-6215
eISSN: 1745-6215
Publisher: BMC
Grant note: National Institute of Mental Health (NIMH; FAIN): R61MH129407, R01MH130566 National Center for Complementary and Integrative Health: K23AT010879
The research methods reported in this paper are supported by the National Institute of Mental Health (NIMH; FAIN #: R61MH129407) awarded to Dr. Meyer. Drs. Meyer and Wade were also supported by R01MH130566. Dr. Goldberg was supported via a career development award from the National Center for Complementary and Integrative Health (K23AT010879).The NIH had no role in the design of this study and will not have any role in the collection, management, analysis, interpretation, and writing of this or other manuscripts derived from this trial.
Language: English
Date published: 10/07/2024
Academic Unit: Psychological and Brain Sciences
Record Identifier: 9984721103002771

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