Clinical trial NCT06001346: CBT+ for Depression
Official title: ActiveCBT for Depression: Transforming Treatment Through Exercise Priming
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Exercise Priming
Depression
Cognitive Behavioral Therapy
Lead sponsor: Iowa State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effects of a novel intervention approach, intentionally sequencing aerobic exercise immediately prior to therapy sessions (i.e., cognitive behavioral therapy \[CBT\]) to determine its effects on both specific and common factors underlying the antidepressant effect of CBT (i.e., 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 (i.e., 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with DSM-5 MDD, confirmed via SCID.
* Having current depressive symptoms of at least mild severity defined by HAM-D rating ≥8.
* Being between age 18 and 65.
* Either not engaging in any mental health treatment (e.g., medication, psychological, or behavioral) OR on a stable mental health treatment regimen and willing to maintain it for the length of the intervention.
* Willing and safe to exercise based on the Physical Activity Readiness Questionnaire.
* Being CBT-naïve (as defined by never undergoing structured CBT).

Exclusion Criteria:

* currently pregnant, nursing, or planning to become pregnant,
* severe obesity (BMI=40)
* diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
* diagnosed with current Substance Use Disorder, via the SCID
* pose an imminent risk of self-harm or harm to others, assessed via the C-SSRS
* exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, assessed by clinical research personnel

Primary outcomes:
measure: Average self-reported working alliance measured by Working Alliance Inventory (WAI)
timeFrame: Weeks 1-8 CBT+ visits
measure: Average change in self-reported behavioral activation measured by Behavioral Activation for Depression Scale (BADS)
timeFrame: Intake, Weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up
Secondary outcomes:
measure: Changes in clinician-rated depression symptoms measured by GRID-Hamilton Depression Rating Scale (GRID-HAM-D)
timeFrame: Intake, final, 12-week follow up, 1-year follow up
measure: Change in self-reported depression symptoms measured by Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Intake, weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up
measure: Change in MDD diagnosis measured by Structured Clinical Interview for DSM-5 Disorders (SCID)
timeFrame: Intake, final, 12-week follow up, 1-year follow up
measure: Change in suicidal thoughts measured by the Columbia-Suicide Severity Rating Scale (CSSRS)
timeFrame: Intake, weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up
measure: Average anhedonia measured by Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final, 12-week follow up, 1-year follow up
measure: Average anhedonia measured by an Anhedonia Visual Analogue Scale (Anhedonia VAS)
timeFrame: Weeks 1-8 CBT+ visits (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final, 12-week follow up, 1-year follow up
measure: Serum brain derived neurotrophic factor (BDNF)
timeFrame: Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
measure: Change in monitor-assessed physical activity measured by accelerometry
timeFrame: Intake, weeks 4 & 8 CBT+ visits (monitors worn 1 week following each time point)
measure: Change in self-reported physical activity measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: Intake, week 4 CBT+ visit, final, 12-week follow up, 1-year follow up
measure: Change in quality of life measured by the 36-Item Short Form Health Survey (SF-36)
timeFrame: Intake, week 4 CBT+ visit, final, 12-week follow up, 1-year follow up
measure: Change in anxiety measured by Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Intake, week 4 CBT+ visit, final, 12-week follow up, 1-year follow up
measure: Average automatic thoughts measured by Automatic Thoughts Questionnaire (ATQ)
timeFrame: Intake, weeks 1-8 CBT+ visits, final, 12-week follow up, 1-year follow-up
measure: Average session effectiveness measured by Session Evaluation Questionnaire (SEQ)
timeFrame: Weeks 1-8 CBT+ visits
measure: Average Lyssn generated scores
timeFrame: Weeks 1-8 CBT+ visits
measure: Nature Connectedness Index (NCI)
timeFrame: Intake, Weeks 1, 4, and 8 CBT+ visits (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)
Other outcomes:
measure: Health History Questions
timeFrame: Intake
measure: Demographic Questionnaire
timeFrame: Intake
measure: Adverse Childhood Experience Survey (ACES)
timeFrame: Intake
Locations:
city: Ames
country: United States
facility: Iowa State University
state: Iowa
Study officials:
References: