Exercise-priming of CBT for Depression: the CBT+ Trial

Обзор

This study investigates the effects of intentionally sequencing aerobic exercise immediately prior to cognitive behavioral therapy (CBT) to determine its effects on mechanisms of CBT (i.e., working alliance, behavioral activation). To assess the utility of this treatment augmentation, investigators will conduct a randomized controlled trial involving 100 adults with Major Depressive Disorder who will watch a nature documentary while either resting quietly ( 'CalmCBT') or exercising at a moderate intensity ('ActiveCBT') immediately prior to 8 weekly sessions of CBT.

Подробное описание

The overall goals of this project are to examine the efficacy of exercise priming (i.e., intentional sequencing of aerobic exercise immediately prior to cognitive behavioral therapy \['ActiveCBT'\]) to treat depression.

Specific aims are to 1) demonstrate the effects of exercise priming on mechanisms associated with therapy success (i.e., working alliance, behavioral activation) and 2) determine the efficacy of exercise priming for treatment of depression and strength of relationship with engagement of target CBT mechanisms.

The primary outcomes of this trial are participant-rated working alliance and change in behavioral activation each averaged across all eight sessions. Secondary outcomes include post-intervention depressive scores (Hamilton Depression Rating Scale).

For safety, suicide severity will be evaluated using the Columbia-Suicide Severity Rating Scale.

Вмешательства

• Поведенческое Rest
  30 minutes of rest while watching a nature documentary before cognitive behavioral therapy
• Поведенческое Aerobic Activity
  30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.

Первичные конечные точки

• Working Alliance Inventory (WAI) - Bond subscale [Срок оценки: data collected at each CBT session (weeks 1-8)]
• Behavioral Activation for Depression Scale (BADS) [Срок оценки: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52]
• GRID Hamilton Rating Scale for Depression (GRID-HAMD) [Срок оценки: baseline, post intervention visit (week 9), week 20, week 52]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52]

Вторичные конечные точки (12)

• Structured Clinical Interviews for DSM-5 Disorders (SCID) [Срок оценки: baseline, post intervention visit (week 9), week 20, week 52]
• Columbia Severity Suicide Rating (CSSRS) [Срок оценки: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52]
• Dimensional Anhedonia Rating Scale (DARS) [Срок оценки: Weeks 1-8 CBT sessions (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final visit (week 9), 20-week follow up, 1-year follow up]
• Visual Analogue Scale (VAS) [Срок оценки: Weeks 1-8 CBT sessions (repeated 3 times [before exercise/calm condition, immediately after exercise/calm condition, and after therapy]), final visit (week 9), 20-week follow up, 1-year follow up]
• Serum Brain Derived Neurotrophic Factor (BDNF) [Срок оценки: Weeks 1, 4, and 8 CBT sessions (before exercise/calm condition, immediately after exercise/calm condition, and after therapy)]
• Objective physical activity data (activPAL accelerometer) reported in minutes [Срок оценки: Baseline, weeks 3 & 8 CBT sessions (monitors worn 1 week following each time point)]
• Objective physical activity data (activPAL accelerometer) reported in number of steps per day [Срок оценки: Baseline, weeks 3 & 8 CBT sessions (monitors worn 1 week following each time point)]
• Self-reported physical activity measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) reported in minutes [Срок оценки: baseline, week 4, post intervention visit (week 9), week 20, week 52]
• 36-item Short Form health survey (SF-36) [Срок оценки: baseline, week 4, post intervention visit (week 9), week 20, week 52]
• Generalized Anxiety Disorder 7 questionnaire (GAD-7) [Срок оценки: baseline, week 4, post intervention visit (week 9), week 20, week 52]
• Automatic Thoughts Questionnaire [Срок оценки: baseline, weeks 1-8, post intervention visit (week 9), week 20, week 52]
• Session Evaluation Questionnaire (SEQ) [Срок оценки: Weeks 1-8 CBT sessions]

Критерии участия

Критерии включения

• a diagnosis of DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID)
• current depressive symptoms of at least mild severity defined by a Hamilton Rating Scale of Depression (using the GRID-HAMD) score greater than or equal to 8
• EITHER not currently take any mental health medications or use other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and encouraged to maintain that regimen for the duration of the 8 week intervention period
• willing and safe to perform exercise based on responses on the Physical Activity Readiness Questionnaire (rules out contraindications to exercise)
• reported being CBT-naïve (as defined by never undergoing structured CBT).

Критерии исключения

• reporting being currently pregnant, nursing, or planning to become pregnant during the study
• being diagnosed with current Substance Use Disorder, via the SCID
• being diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
• having class III+ obesity (BMI greater than or equal to 40)
• active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale \[C-SSRS\])
• exhibiting behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) or relationships with the study team members (e.g., therapists) that would significantly interfere with study participation, as assessed by research personnel.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Публикации

• Meyer JD, Kelly SJE, Gidley JM, Lansing JE, Smith SL, Churchill SL, Thomas EBK, Goldberg SB, Abercrombie HC, Murray TA, Wade NG. Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial). Trials. 2024 Oct 7;25(1):663. doi: 10.1186/s13063-024-08495-x. PMID 39375728

Идентификаторы

NCT: NCT07221929 · 2025-1128 · R33MH129407 · EDUC/KINESIOLOGY · Protocol Version 12/19/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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