Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06001346
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-08-14
Brief Title:
CBT for Depression
Sponsor:
Iowa State University
Organization:
Iowa State University
Study Overview
Official Title:
ActiveCBT for Depression Transforming Treatment Through Exercise Priming
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBT
Brief Summary:
This study investigates the effects of a novel intervention approach intentionally sequencing aerobic exercise immediately prior to therapy sessions ie cognitive behavioral therapy CBT to determine its effects on both specific and common factors underlying the antidepressant effect of CBT ie mechanisms of CBT To assess the utility of this treatment augmentation investigators plan to conduct a randomized controlled trial involving 40 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly termed CalmCBT or exercising at a moderate intensity ActiveCBT immediately prior to 8 weekly sessions of CBT It is hypothesized that target CBT mechanisms of antidepressant action ie self-reported working alliance and behavioral activation will be more effectively engaged by ActiveCBT vs CalmCBT
Detailed Description:
Frontline treatments for major depressive disorder MDD including cognitive behavioral therapy CBT have limited effectiveness with half of patients not responding to CBT and half relapsing within 2 years Strategies that increase the potency of MDD treatments are needed We are testing a novel treatment strategy using aerobic exercise to prime a subsequent CBT session ActiveCBT Exercise priming is hypothesized to lead to greater engagement of CBT mechanisms of action through both common and specific factors linked to depression outcomes this CBT augmentation approach has yet to be empirically tested The study will consist of an 8-week randomized controlled trial in 40 adults with MDD performing 30-minutes of moderate exercise or quiet rest CalmCBT vs ActiveCBT prior to weekly CBT sessions Using a time- and attention-matched control all participants will view a standardized documentary series for these 30 pre-therapy minutes with the only difference between groups being exercise or calmly resting This project will also employ machine learning and natural language processing via the Lyssn platform to objectively evaluate the language and words used during therapy The overall goals are to 1 demonstrate exercise priming effects on target CBT mechanisms 2 link psychological and neuroplastic exercise priming to CBT mechanisms and 3 explore the sensitivity of objective machine learning-based markers from Lyssn to ActiveCBT-induced therapy differences This trial will establish the potential for a subsequent confirmatory efficacy trial to rigorously test the potential of exercise priming to enhance treatment If this innovative biologically-informed approach successfully primes subsequent therapy this could be used to augment other treatments and in other disorders significantly improving mental health treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R61MH129407-01A1 | NIH | None | httpsreporternihgovquickSearch1R61MH129407-01A1 |