The Function of Avoidance in Depressed Behavior and a Pilot of Transdiagnostic Behavioral Activation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 895
- 试验地点
- 2
- 主要终点
- Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
研究概览
简要总结
Psychological therapies for depression have demonstrated efficacy, but outcomes are still unsatisfactory, especially in cases with high comorbidity. Depression and anxiety co-occur in up to 69-75% of teens and intensify functional impairment and service use. This study will develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT) and conduct a pilot waitlist-controlled school-based study with 35 7th and 8th grade boys and girls with co-occurring depression and anxiety. Multi-reporter, multi-domain assessments will be conducted at initial screening, pre- and post-treatment, and 4-month follow-up. BA is a straightforward, but flexible and robust, therapy that has demonstrated strong results in adults. Current formulations of BA highlight the specific role of avoidance in depressotypic behavior. It presumes that anhedonia, isolation, and negative behaviors associated with depression function to avoid imminent distress even as it blocks access to otherwise available positive reinforcement. This study will therefore employ novel electronic diary technology to obtain Ecological Momentary Assessment and evaluate: (a) the function of avoidance in distinguishing youth with depression (n=35) from a non-clinical comparison group (n=18), and (b) the role of avoidance in mediating treatment gains in participants in the GBAT intervention.
详细描述
Specific Aims and Hypotheses:
This study will develop treatment materials for a transdiagnostic Group Behavioral Activation Therapy (GBAT). It will then conduct a double-gated screening of middle-school students (N=895) to identify youth with subclinical or clinical DSM-IV-TR anxiety or mood disorders. Eligible youth (N=35) will then participate in a randomized clinical trial of GBAT where 21 will be randomly assigned to GBAT and 14 to a 15-week waitlist period. This addresses critical needs to develop first-line early interventions that are evidence-based and can efficiently address commonly co-occurring problems in settings where treatment is needed most.
Aim 1. To develop treatment materials and test GBAT's feasibility (e.g., recruitment and retention rates, therapist adherence) and acceptability to youth participants (client satisfaction, group cohesion, homework completion).
Aim 2. To estimate initial efficacy of GBAT compared to a waitlist (WL) control in a randomized pilot study with 35 youth (21 assigned to two GBAT groups; 14 assigned to WL). It is hypothesized that GBAT will show greater pre- to post-treatment outcomes on primary (clinical diagnosis, symptom severity) and secondary measures (achievement of target goals, reduced avoidance, social and academic adjustment). Youth who receive GBAT will also show linear improvement on outcome measures from pretreatment through four-month follow-up.
A second major goal of the project is to understand the functional role of avoidance in depression. Participating youth will carry Electronic Diaries (EDs; i.e., ipod touch) throughout the active treatment and follow-up phases and complete twice-daily reports of negative events, emotional and behavioral responses, and perceived function of one's responses. A non-clinical comparison group (n=18) will also carry EDs during a two-week period. Such Ecological Momentary Assessment (EMA) data has been used effectively with youth populations to determine the impact of positive and negative coping responses on depressive symptoms.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical (ADIS CSR ≥ 4) or subclinical (ADIS CSR = 2-3) principal diagnosis of either a DSM-IV-TR unipolar depression disorder (Major Depressive Disorder ([MDD], Minor Depression [MinD], or Dysthymia [Dys]) or
- •an anxiety disorder (Generalized Anxiety Disorder [GAD], Social Phobia [SOP], Separation Anxiety [SAD]).
排除标准
- •any principal diagnosis other than anxiety or depression or parent report of mental retardation,
- •pervasive developmental disorder,
- •schizophrenia, or
- •bipolar disorder, or
- •report of past-year hospitalization for a suicide attempt. Concurrent use of antidepressant or anxiolytic medications was permitted as long as dosage was stable for at least four weeks and the family intended to maintain the dose.
研究组 & 干预措施
waitlist
15-week waitlist
Group Behavioral Activation Therapy
Group Behavioral Activation Therapy (GBAT)
干预措施: Group Behavioral Activation Therapy (GBAT) (Behavioral)
结局指标
主要结局
Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)
时间窗: Change from baseline (pretreatment) diagnosis at 15 weeks
ADIS-IV-TR is a semi-structured interview that assesses presence and severity of DSM-IV-TR diagnoses, including parent, child, and consensus diagnosis. Impairment (Clinician's Severity Rating; CSR) is rated per disorder on a 0 (not at all) to 8 (debilitating) scale where 4 represents clinical threshold. The ADIS-IV-TR is administered at pretreatment, posttreatment, and 4-mo FU.
次要结局
- Change in Diagnosis via the Anxiety Disorders Interview Schedule-IV-TR (ADIS-IV-TR)(Change from baseline (pretreatment) diagnosis at 31 weeks)
- Change in Children's Depression Rating Scale-Revised (CDRS-R)(Change from baseline (pretreatment) symptoms at 15 weeks)
研究者
Brian C. Chu
Principal Investigator; Associate Professor
Rutgers University