Multi-level Mechanisms of Behavioral Activation Therapy for Adolescent Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 6
- 主要终点
- Change in Diagnostic Interview Status (CDRS-R) total score from baseline
研究概览
简要总结
The investigators will be comparing brain (neural) activation of depressed adolescent patients before, during and after a course of Behavioral Activation (BA) therapy using functional magnetic resonance imaging (fMRI). In particular, the project seeks to determine whether BA targets different neural mechanisms for behavioral avoidance associated with low motivation as compared to threat avoidance. A group of healthy controls will also be scanned as a comparator group for behavioral and imaging measures.
详细描述
The primary aim of this study is to investigate the behavioral and neurobiological factors predicting response to Behavior Activation (BA), a psychosocial treatment for Major Depressive Disorder (MDD), in adolescents.
The recruitment age pool will be adolescents ages 15-17. The investigators plan to recruit 40 healthy controls and 96 treatment-seeking adolescents for an overall sample of ~136 participants, Individuals who reach the age of majority (18) during the study will be re-consented as adults and allowed to continue participating in the study.
A healthy control group will be included to assess stability in behavioral and neuroimaging measures over the course of participation in the study.
The fMRI scan schedule will include three task-based sessions (baseline, after session 7, and after endpoint) and two (sessions 3 & 9). "behavioral-scheduling-in-the-scanner" sessions Primary results will focus on symptom change within patients and their association to measures of low motivation and threat avoidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female adolescents ages 15-17;
- •current MDD diagnosis as determined by K-SADS-PL,
- •CDRS-R raw score > 45 (T-score > 65) at baseline;
- •estimated full scale IQ > 80 as determined by the WASI-II;
- •able to receive outpatient care;
- •willing to not partake in other psychosocial treatments;
- •not taking psychotropic medications in the two weeks (four weeks for fluoxetine) prior to consent, with the exception of psychostimulant medication prescribed for the treatment of ADHD.
- •Additionally, depressed patients must have access to required technology (e.g. smart phone, tablet, or desktop computer) to complete the EMA portion of the study.
- •Healthy controls cannot not meet criteria for MDD and their CDRS-R raw score must be below 28; T-score < 52).
排除标准
- •Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis NOS;
- •current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, OCD, or autism-spectrum disorders;
- •taking psychotropic medications prior to entry;
- •estimated IQ < 80; alcohol/drug dependence or abuse within the last 3 months;
- •potential/confirmed neurological disorder or epilepsy;
- •claustrophobia;
- •presence of a medical condition that precludes fMRI;
- •endorsement of imminent and serious suicidality;
- •medical conditions that take precedence over the presence of MDD;
- •pregnancy;
- •substance use (excluding nicotine) within two weeks of the fMRI scan;
- •left-handedness;
- •nicotine use within 3 hours of the fMRI scan;
- •history of traumatic brain injury or of being unconscious for more than 30 minutes;
- •a stimulant regime for ADHD which has changed within 30 days of the fMRI scan.
- •Non-compliance (i.e. <70% completion) or inability (i.e. lack of smartphone device) to complete the 3 assessment periods of EMA.
研究组 & 干预措施
MDD patients
Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.
干预措施: Behavioral Activation Therapy (Behavioral)
MDD patients
Participants will be seen for a maximum of 16 sessions over 16 weeks. Two extra sessions will be allowed during treatment.
干预措施: Baseline assessment procedures (Behavioral)
结局指标
主要结局
Change in Diagnostic Interview Status (CDRS-R) total score from baseline
时间窗: Baseline, week 16 post intervention
Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. Following on prior studies of adolescent MDD, a diagnosis of MDD and a CDRS-R score of 45 or greater is the criterion for admission to the study. A score of 27 or less at the end of the study is the criterion for remission of MDD.
Change in Adolescent Longitudinal Interval Follow-Up Evaluation (A-LIFE)
时间窗: Week 8 post intervention (Midpoint), week 16 post intervention
The A-LIFE Interview, developed for use with adolescents, was based on the Longitudinal Interval Follow-up Evaluation scale (LIFE), a clinical interview for adults. The A-LIFE comprises three general sections, including psychopathology, psychosocial functioning, and general severity of the disorder (GSD). The psychopathology domain will be used in the current study because it provides information regarding whether the participant has met the criteria and symptoms of DSM-5 disorders. The A-LIFE measure of greatest interest in the current study is the 6-point rating of each identified psychiatric disorder. Each form of psychopathology is scored 1-6, and a depression score of 4, 5, or 6 yields a positive diagnosis of MDD. The primary outcome variable will be the number of MDD patients reaching remission status (\<4).
次要结局
- Change in Beck Depression Inventory (BDI-II)(Baseline, weekly therapy visits 1-16 post intervention)
研究者
Michael Treadway
Professor
Emory University