Exploring the Acceptability and Efficacy of a Transdiagnostic Treatment for Misophonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)
研究概览
简要总结
Despite increasing recognition of misophonia, there are currently no evidence-based treatments to help those who are suffering. Therefore, the primary purpose of this study is to assess the acceptability, feasibility, and preliminary efficacy of a treatment for misophonia. This study will be conducted in two phases. In the Phase 1, participants will receive a treatment the investigators believe can help manage symptoms of misophonia: The Unified Protocol. This treatment uses evidence-based psychological principles (e.g., managing attention or behavior) in a flexible manner and will focus on developing skills to help reduce the distress and impairment associated with Misophonia. After treatment, patients will provide feedback about their experience. The investigators will use this feedback to revise the treatment as indicated. In Phase 2, participants will receive the revised treatment and provide feedback on their experience. Throughout treatment in either phase, participants will provide daily and weekly information about their symptoms.
The aims of this study are (1) to explore the acceptability and feasibility of the Unified Protocol for individuals who experience Misophonia and (2) to examine whether this treatment helps reduce symptoms associated with Misophonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Between age 18-65
- •Able to read English
- •Meet criteria for interfering symptoms of misophonia
- •Live in North Carolina
排除标准
- •Under age 18 or over age 65
- •Current mania
- •Current psychotic disorder
- •Current anorexia
- •Presents with a condition that requires immediate prioritization in treatment (e.g., suicide planning or intent)
- •Phase 1 participants cannot also participate in Phase 2.
结局指标
主要结局
Number of patients who report a decrease in anxiety sensitivity on the Anxiety Sensitivity Index (ASI)
时间窗: up to 24 weeks
The ASI is an 18 measure that assesses how often a participant experiences anxiety symptoms
Number of patients who indicate treatment was acceptable to them (i.e., the treatment approach made sense and was perceived as reasonable)
时间窗: up to 20 weeks
The Satisfaction with Therapy and Therapist Scale is a 13-item measure that asks patients about their satisfaction with treatment and with their therapist.
Number of patients who use cognitive flexibility skills assessed by the UP Cognitive Skills Questionnaire (CSQ)
时间窗: up to 24 weeks
The CSQ is a 10-item measure that assesses use of cognitive skills taught in treatment
Change in anxiety as measured by the Overall Anxiety Severity and Impairment Scale
时间窗: assessed weekly, up to 24 weeks
The Overall Anxiety Severity and Impairment Scale is a five item measure that assesses interference and distress related to the experience of anxiety. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.
Number of patients that are satisfied with treatment as measured by the credibility and expectancy questionnaire (CEQ
时间窗: up to 20 weeks
The CEQ is a 6-item measure that asks patients about their perceptions of treatment.
Number of Patients who use behavior change skills assessed by the UP Behavioral Avoidance Questionnaire (BAQ)
时间窗: up to 24 weeks
The BAQ is a five item measure that assesses use of behavior change skills taught in treatment.
Change in anger as measured by the PANAS Hostility Scale
时间窗: assessed weekly, up to 24 weeks
The PANAS Hostility Scale is a 6 item scale that assesses how often a participant experienced anger in the past week.
Number of sessions attended
时间窗: up to 20 weeks
The number of sessions attended will provide an estimate of the feasibility of attending and completing this treatment
Number of Patients who use behavior change skills assessed by the Brief Experiential Avoidance Questionnaire (BEAQ)
时间窗: up to 24 weeks
The BEAQ is a 13 item measure that assesses how often a participant avoids emotion-provoking situations
Number of patients who use mindfulness skills assessed by the Southampton Mindfulness Questionnaire (SMQ)
时间窗: up to 24 weeks
The SMQ is a 16-item measure that asks patients about their use of mindfulness skills .
Change in misophonia symptoms as assessed by the Misophonia Questionnaire
时间窗: assessed weekly, up to 24 weeks
The Misophonia Questionnaire is a 17-item questionnaire that assesses the presence of misophonia symptoms, emotions and behaviors associated with misophonic reactions, and symptom severity. The first two subscales are rated on a scale of 0 (not at all true) to 4 (always true). These two parts are summed to produce a total score ranging from 0 - 68. The severity subscale is a single item that asks an individual to provide a rating of their sound sensitivity on a scale from 0 (no sound sensitivities) to 15 (very severe sound sensitivities).
Change in depression as measured by the Overall Depression Severity and Impairment Scale
时间窗: assessed weekly, up to 24 weeks
The Overall Depression Severity and Impairment Scale is a five item measure that assesses interference and distress in an individual's day-to-day life related to the experience of depression. Items are scored from 0 to 4 and summed to produce a total score (ranging from 0 - 20), with higher scores indicating greater functional impairment.
次要结局
- Number of seconds participant engaged in a physiological challenge exercise(up to 20 weeks)
- Number of patients who report a change in cognitive flexibility as measured by the Stroop test(up to 20 weeks)
- Number of patients who report a change in cognitive flexibility as measured by the Trail Making Test(up to 20 weeks)
- Number of patients who report a change in attentional control as measured by the Trail Making Test(up to 20 weeks)
- Number of patients who report a change in attentional control as measured by the Digit Span Test(up to 20 weeks)
- Number of seconds participant engaged in a writing task(up to 20 weeks)