Exercise-priming of CBT for Depression: the CBT+ Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
CalmCBT
In this arm, participants would complete 30 minutes of rest while watching a nature documentary before cognitive behavioral therapy
干预措施: Rest (Behavioral)
ActiveCBT
In this arm, participants would complete 30 minutes of aerobic activity before cognitive behavioral therapy, while watching the same nature documentary the CalmCBT group watches.
干预措施: Aerobic Activity (Behavioral)
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9)
时间窗: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52
The PHQ-9 is a 9-item questionnaire that asks the participant to consider the last 2 weeks and score each question from 0-3 for a total possible range of scores from 0-27 where higher scores indicate increase depression.
Working Alliance Inventory (WAI) - Bond subscale
时间窗: data collected at each CBT session (weeks 1-8)
The WAI-Bond subscale scores 4 items, with scores ranging from 4-28. Higher scores are stronger perceived patient-therapist bond: how the participant experiences feelings of bond (i.e., feelings of mutual trust, acceptance, and connection) with their therapist.. The Bond subscale is a primary outcome measure for this study and the total score will be analyzed as a secondary outcome.
Behavioral Activation for Depression Scale (BADS)
时间窗: data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52
BADS is a 25-item survey, each item scored from 0 (not at all) to 6 (completely), with some items reverse scored. There are 4 sub-scales: Activation, Avoidance / Rumination, Work / School Impairment, Social Impairment. The total possible range of scores is from 0 to 150 where higher scores indicate higher behavioral activation (increased avoidance and impairment).
GRID Hamilton Rating Scale for Depression (GRID-HAMD)
时间窗: baseline, post intervention visit (week 9), week 20, week 52
The GRID-HAM-D is a 17-item clinician-completed questionnaire that will be used to rate depressive symptom severity. The questionnaire is designed for adults and is used to rate the intensity and frequency of depressive symptoms by probing mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. As recommended by the Depression Rating Scale Standardization Team, Clinical Interviewers will follow the Structured Interview Guide and use GRID scoring, in which dimensions of intensity and frequency of a symptom are rated independently for each item. Higher scores reflect greater symptom severity, categorized as Normal (0-7), Mild Depression (8-13), Moderate Depression (14-18), Severe Depression (19-22), and Very Severe Depression (greater than 23).
次要结局
- Structured Clinical Interviews for DSM-5 Disorders (SCID)(baseline, post intervention visit (week 9), week 20, week 52)
- Columbia Severity Suicide Rating (CSSRS)(data collected at baseline, each CBT session (weeks 1-8), post intervention visit (week 9), week 20, week 52)
- The Lam Employment Absence and Productivity Scale (LEAPS)(baseline, post intervention visit (week 9), week 20, week 52)
- Working Alliance Inventory (WAI) - Total(data collected at each CBT session (weeks 1-8))
- Self-reported physical activity measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF) reported in minutes(baseline, week 4, post intervention visit (week 9), week 20, week 52)
- 36-item Short Form health survey (SF-36)(baseline, week 4, post intervention visit (week 9), week 20, week 52)
- Dimensional Anhedonia Rating Scale (DARS)(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)(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)(Weeks 1, 4, and 8 CBT sessions (before exercise/calm condition, immediately after exercise/calm condition, and after therapy))
- Generalized Anxiety Disorder 7 questionnaire (GAD-7)(baseline, week 4, post intervention visit (week 9), week 20, week 52)
- Automatic Thoughts Questionnaire(baseline, weeks 1-8, post intervention visit (week 9), week 20, week 52)
- Session Evaluation Questionnaire (SEQ)(Weeks 1-8 CBT sessions)
- Average Lyssn-generated score(Weeks 1-8 CBT sessions)
- The Patient Global Impression of Change scale (PGIC)(Weeks 9, 20, and 52)
- REST-Q(baseline, post intervention visit (week 9), week 20, week 52)
- Emotion Regulation Questionnaire (ERQ)(baseline, post intervention visit (week 9), week 20, week 52)
- Rumination Reflection Questionnaire (RRQ)(baseline, post intervention visit (week 9), week 20, week 52)
- Objective physical activity data (activPAL accelerometer) reported in minutes(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(Baseline, weeks 3 & 8 CBT sessions (monitors worn 1 week following each time point))