Increasing Treatment Efficacy Using SMART Methods for Personalizing Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
研究概览
简要总结
The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of at least one anxiety disorder, trauma- or stressor-related disorder, or obsessive-compulsive disorder
- •fluent in English
- •medication stability
排除标准
- •concurrent therapy
- •psychological condition that would be better addressed by alternative treatments
- •have received more than 5 sessions of cognitive behavioral therapy in the past 5 years
结局指标
主要结局
Change in Clinician-Rated Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
时间窗: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)
Clinician-rated depressive symptoms will be measured using the Hamilton Rating Scale for Depressive Symptoms. Scores range from 0-68; higher scores indicate greater severity. Negative scores indicate symptom improvement. Outcomes for participants in brief intervention groups is the difference in Clinician-Rated symptom scores before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in Clinician-Rated symptom scores before and after 12 sessions.
Change in Self-Reported Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
时间窗: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)
Anxiety symptoms will be measured using the Overall Anxiety Severity and Interference Scale (OASIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported
Change in Self-Reported Depressive Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
时间窗: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)
Depressive symptoms will be measured using the Overall Depression Severity and Interference Scale (ODSIS). This is a self-report measure in which scores range from 0-20; higher scores indicate more severe anxiety symptoms. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported
Change in Self-Reported Aversive Reactions to Emotions From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
时间窗: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)
Aversive reactions to emotions will be measured using the distress aversion subscale of the Multidimensional Experiential Avoidance Questionnaire (MEAQ). This is a self-report measure in which scores range from 13-78; higher scores indicate greater negative reactions to emotional experiences. Negative scores indicate symptom improvement. assessed at baseline and weekly for 6 or 12 weeks, change from baseline after 6 sessions (6 weeks) and after 12 sessions (12 weeks) are being reported
Change in Clinician-Rated Anxiety Symptoms From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
时间窗: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention)
Clinician-rated anxiety symptoms will be measured using the Hamilton Rating Scale for Anxiety Symptoms. Scores range from 0-56; higher scores indicate greater severity. Negative scores indicate symptom improvement. Outcomes for participants in brief intervention groups is the difference in clinician rated symptom scores before and after 6 treatment sessions and outcomes for participants in full intervention groups is the difference in clinician rated symptom scores before and after 12 sessions.
Change in Clinical Severity From Baseline to 6 Weeks (Brief Intervention) or 12 Weeks (Full Intervention)
时间窗: Baseline to 6 weeks (Brief Intervention), Baseline to 12 weeks (Full Intervention
Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity. Negative scores indicate symptom improvement.
次要结局
未报告次要终点
研究者
Shannon E. Sauer-Zavala
Assistant Professor
University of Kentucky