This study will assess the effect of combining exercise therapy with CBT 12-16 weeks and explore the mechanisms underlying exercise*s mood- and plasticity-boosting effects. The primary question is whether a higher dose of exercise leads to faster or…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is clinical improvement (decreases in depressive symptoms
and improved CBT skills) from baseline to post-treatment measured weekly, and
to 3-month follow-up.
Secondary outcome
Secondary parameters are physical activity, mood states, emotional
autobiographical memory, energy, motivation, biomarker levels of
endocannabinoids and brain-derived neurotropic factor, genetics, and daily
functioning.
Background summary
Cognitive Behavioural Therapy (CBT) remains a leading first-line treatment for
depression, yet it has a non-response rate of around 40%, highlighting a
critical need for effective augmentation strategies. Exercise, an accessible
and side-effect-free intervention, shows promise in reducing depressive
symptoms and enhancing neuroplasticity. Combining exercise therapy with CBT may
accelerate skill acquisition and improve treatment outcomes. This study aims to
explore the synergistic potential of synchronizing exercise therapy and CBT,
with the goal of optimizing therapeutic efficacy for individuals with
depression.
Study objective
This study will assess the effect of combining exercise therapy with CBT 12-16
weeks and explore the mechanisms underlying exercise*s mood- and
plasticity-boosting effects. The primary question is whether a higher dose of
exercise leads to faster or greater CBT skill acquisition and symptom reduction
in depressive outpatients compared to a lower dose during and after the
program.
Study design
This study is a prospective cohort study. The treatment period is 12-16 weeks
with weekly assessments until 1-week post-treatment and 3-month post-treatment;
daily assessments with smartphone-based assessment, and continuous physical
activity tracking.
Intervention
The 12-16 week intervention encompasses weekly supervised 45-min exercise
sessions (moderate intensity aerobic exercise) followed by CBT, both in group
setting. Additionally, participants are prescribed two weekly homework exercise
sessions.
Study burden and risks
Minimal potential risk is associated with this study. Both interventions are
already part of care-as-usual in the Dutch mental health setting. The burden
added by this study is the time participants need to invest in the assessments,
which is about 20 minutes each treatment week for the ecological momentary
assessment, 90 minutes for the baseline assessment and 30 minutes each for the
post-intervention and follow-up assessment.
Reinier Postlaan 10
Nijmegen 6525CG
NL
Reinier Postlaan 10
Nijmegen 6525CG
NL
Listed location countries
Age
Inclusion criteria
• Adult: age 16 +
• Current diagnosis of major depressive disorder, based on the Structured
Clinical Interview for DSM-5 (SCID-5-S)(First et al., 1998) flanked with
clinical judgement.
• Currently exercising max. once per week, based on telephonic assessment
Exclusion criteria
• Impossibility to obtain a valid informed consent
• Physical, cognitive, or intellectual impairments interfering with
participation
• High health risks of physical activity (determined by clinician and/or
assessed using the Physical Activity Readiness Questionnaire; Shephard et al.,
1981)
• Lifetime manic episode
• Insufficient comprehension of Dutch language
• Current admission to treatment centre
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88643.091.25 |