An Analysis of Change Processes in the Transdiagnostic Treatment of Emotional Disorders in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in DSM-5 Anxiety and Depressive Disorder Diagnoses and Severity in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C/P)
研究概览
简要总结
The purpose of this protocol is to employ single case analytic strategies, including a multiple baseline design and novel modeling techniques to identify changes in cross-cutting features of emotional disorders as well as emotional disorder symptoms during the implementation of The Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A). The first aim is to investigate relationships between the use of UP-A treatment components and changes in measures of cross-cutting features of emotional disorders. The second aim is to investigate when and how reductions in symptoms of emotional disorders and presenting problems (i.e., symptoms of anxiety and depression, severity of presenting problems) occur throughout treatment.
详细描述
The goal of this study is to examine how a core dysfunction transdiagnostic psychotherapy for emotional disorders in youth influences change in cross-cutting features both theoretically linked to neuroticism and also targeted by this treatment. Another goal is to investigate change in symptoms of emotional disorders, including anxiety and depression, throughout the course of this treatment, the Unified Protocol for the Treatment of Emotional Disorders in Adolescents (UP-A).
My long-term goal is to identify ways to personalize an effective psychotherapy model for an array of youth emotional disorders by determining how and when implementation of different components of the UP-A influence change in mental health. My research objective in this study is to use group-level and novel single case analytic strategies to identify changes in emotional disorders during the implementation of the UP-A, a transdiagnostic form of cognitive behavior therapy (CBT) for adolescents. Specifically, I am interested in examining how features of the core dysfunction targeted by the UP-A, high neuroticism as well as symptoms of emotional disorders change throughout UP-A treatment. My central hypothesis is that adolescents with emotional disorders will display changes in measures of core dysfunction and reductions in symptoms of emotional disorders throughout UP-A treatment.
Aim 1: Investigate relationships between the use of UP-A treatment components and changes in measures of neuroticism, a core dysfunction that cuts across of emotional disorders. The main working hypothesis is that the administration of the UP-A will result in observable changes in measures of cross-cutting features of emotional disorders linked to neuroticism (cognitive flexibility, distress tolerance, and experiential avoidance). Such changes will occur after the introduction of relevant core principles of the UP-A. The proposed study is designed to determine whether change in these aspects of neuroticism and emotional disorder symptoms occur directly following the presentation of treatment components, or whether changes might instead be staggered throughout treatment.
Aim 2: Investigate when and how reductions in symptoms of emotional disorders (i.e., symptoms of anxiety and depression, severity of presenting problems) occur throughout treatment. Based on knowledge obtained from previous randomized, controlled trials (RCTs) focusing on the treatment of anxiety, depressive and related disorders, the main working hypothesis of Aim 2 is that the severity of emotional disorder symptoms will decrease from pre- to post-treatment.
Exploratory Aim 3: Investigate aspects of neuroticism as potential mechanisms of change in emotional disorder symptoms. The primary working hypothesis of Aim 3 is that changes in features of neuroticism targeted by the UP-A will precede changes in anxiety and depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators to conduct post-treatment evaluations.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents must be between 13 and 17 years of age
- •Adolescents must have a primary DSM-5 anxiety or depressive disorder based on results of a diagnostic interview administered by a trained clinician at intake within protocol 20130139
- •Adolescents must indicate elevated symptoms of depression via adolescent and/or parent report of symptoms (RCADS and/or RCADS-P Depression Subscale Index T-Score ≥ 60) and anxiety (RCADS and/or RCADS-P Total Anxiety Subscale Index T-Score ≥ 60) at intake
- •If relevant, adolescents must be on a stable dose of any SSRI/SNRI medication
- •Adolescents must self-report the ability to speak/read English sufficiently (and have at least one parent who can) to complete all study measures in English
- •Adolescents must have a legal guardian available to sign study consents, remain present during assessments, and fill out study questionnaires.
排除标准
- •Adolescents obtain a Full Scale IQ score below 80 on the Vocabulary and Matrix Reasoning subtests of an abbreviated IQ test
- •Adolescents indicate possible cognitive delays that could interfere with successful completion of study procedures
- •Adolescents currently receiving psychotherapy elsewhere.
研究组 & 干预措施
2 Week Waitlist
Participants assessed weekly (via self- and parent-report questionnaires administered on the internet) for symptom change during waitlist (baseline) period. At the end of waitlist and prior to treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.
3 Week Waitlist
Participants assessed weekly (via self- and parent-report questionnaires administered on the internet) for symptom change during waitlist (baseline) period. At the end of waitlist and prior to treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.
4 Week Waitlist
Participants assessed weekly (via self- and parent-report questionnaires administered on the internet) for symptom change during waitlist (baseline) period. At the end of waitlist and prior to treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.
16 Sessions of Therapeutic Intervention
Participants receive 50 minute sessions weekly of therapeutic intervention (Unified Protocol for the Treatment of Emotional Disorders in Adolescents). Symptom change assessed weekly on the internet or before each session (via self- and parent-report questionnaires). At the end of treatment phase, symptom/disorder change assessed via clinical interview conducted by independent evaluator.
干预措施: Unified Protocol for Emotional Disorders in Adolescents (UP-A) (Behavioral)
结局指标
主要结局
Change in DSM-5 Anxiety and Depressive Disorder Diagnoses and Severity in Accordance with Anxiety Disorders Interview Schedule for the DSM-5, Child and Parent Versions (ADIS-5-C/P)
时间窗: administered pre-baseline (prior to treatment initiation), post-baseline (after 2, 3, or 4 week waitlist period), and post-treatment (after 16 sessions of weekly treatment)
measure of change in diagnostic severity of internalizing disorders pre- to post- treatment
Session to Session Change in a measure of emotion regulation in youth, Emotion Regulation Questionnaire-Child and Adolescent Form (ERQ-CA)
时间窗: to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks
measure of change in cognitive flexibility throughout baseline and treatment conditions
Session to Session Change in a measure of distress tolerance in youth, Distress Tolerance Scale (DTS)
时间窗: to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks
measure of change in distress tolerance throughout baseline and treatment conditions
Session to Session Change in a measure of avoidance behaviors in youth associated with emotional disorders, Emotional Avoidance Strategy Inventory for Adolescents (EASI-A)
时间窗: to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks
measure of change in experiential avoidance throughout baseline and treatment conditions
Session to Session Change in a measure of anxiety and depressive symptoms in youth (self-report), Revised Children's Anxiety and Depression Scale-Short Form (RCADS-Short Form)
时间窗: to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks
indicates change in levels of anxiety and depressive symptoms reported by adolescents throughout baseline and treatment conditions
Session to Session Change in a measure of anxiety and depressive symptoms in youth reported by parents, Revised Children's Anxiety and Depression Scale-Parent Report-Short Form (RCADS-P-Short Form)
时间窗: to be completed by adolescents weekly throughout baseline and treatment phases consisting of one assessment prior to initiating study, once weekly assessments during 2, 3, or 4 week baseline period, and assessments every week for 16 weeks
indicates change in levels of anxiety and depressive symptoms experienced by adolescents as reported by parents of adolescents throughout baseline and treatment conditions
次要结局
- Session to Session Change in a measure of severity of presenting problems in youth, Top Problems(assessed weekly throughout the study (approximately 18-20 weeks))
- Session to Session Change in Score on a measure of youth distress tolerance, The Behavioral Indicator of Resiliency to Distress (BIRD)(administered pre-baseline (prior to treatment initiation), at mid-treatment (after 7th session of weekly therapy), post-treatment (after 16 sessions of weekly treatment))
研究者
Jill May Ehrenreich
Associate Professor
University of Miami