Effectiveness of a Mobile Application Based on Mindfulness-Based Cognitive Behavioral Interventions for the Management of Misophonia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Misophonia Scale Total Score
研究概览
简要总结
Misophonia is characterized by strong emotional and physiological reactions to specific trigger sounds and may interfere with daily functioning and emotional well-being. This randomized controlled trial will evaluate the effectiveness of a mobile application based on mindfulness-based cognitive behavioral interventions for adults with misophonia symptoms.
A total of 60 participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will use a three-week mobile intervention that includes psychoeducation, cognitive behavioral techniques, gradual exposure to trigger sounds, mindfulness, breathing and relaxation exercises, and self-monitoring tools. The control group will not receive the mobile intervention during the study period.
Outcomes will be assessed before the intervention, immediately after the three-week intervention, and four weeks after the intervention. The main outcome will be change in misophonia symptoms. Secondary outcomes will include depression, anxiety, stress, and difficulties in emotion regulation.
详细描述
This study is a randomized controlled trial designed to evaluate the effectiveness of a mobile application based on mindfulness-based cognitive behavioral interventions for individuals with misophonia symptoms.
The mobile intervention was developed to address cognitive, emotional, behavioral, and physiological processes associated with misophonia. The intervention integrates psychoeducation, cognitive behavioral therapy, mindfulness-based strategies, gradual exposure and desensitization, breathing and relaxation exercises, and self-monitoring. The intervention specifically targets threat appraisal, automatic thoughts, avoidance behaviors, physiological arousal, and difficulties in emotion regulation.
A total of 60 eligible participants will be randomly assigned to an intervention group or a control group using stratified block randomization. The intervention group will receive access to the mobile application for three weeks. The application includes educational content about misophonia, identification of individual trigger sounds, cognitive restructuring exercises, a thought diary, graded exposure to trigger sounds, Subjective Units of Distress Scale (SUDS) monitoring, breathing exercises, mindfulness practices, relaxation tools, and supportive audio content. The exposure component includes graded exposure, distress monitoring, breathing support, and a safe-stop option.
Participants will be evaluated at three time points: baseline before the intervention, immediately after completion of the three-week intervention, and four weeks after the intervention. The primary outcome will be change in misophonia symptoms. Secondary outcomes will include depression, anxiety, stress, and difficulties in emotion regulation. These outcomes will be assessed using the Misophonia Scale, the Depression Anxiety Stress Scale-21 (DASS-21), and the 16-item Difficulties in Emotion Regulation Scale.
The study will examine whether the mobile intervention produces improvements in misophonia symptoms and related psychological outcomes compared with the control condition.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Meeting the misophonia criteria proposed by Jager et al. (2020).
- •Reporting at least one trigger sound.
- •Having a Misophonia Scale total score greater than 60.
- •Owning a smartphone or tablet.
- •Having sufficient technological literacy to use the mobile application.
排除标准
- •Misophonia symptoms being better explained by another condition or disorder based on the eligibility screening.
- •A Misophonia Scale total score of 60.5 or lower.
- •Development of marked distress or functional impairment during the study that requires discontinuation and referral for professional mental health support.
研究组 & 干预措施
Intervention Group
Participants assigned to this arm will use the mindfulness-based cognitive behavioral mobile application for three weeks. The intervention includes psychoeducation, cognitive restructuring, graded exposure to trigger sounds, mindfulness practices, breathing and relaxation exercises, and self-monitoring tools.
干预措施: Mindfulness-Based Cognitive Behavioral Mobile Intervention (Behavioral)
Control Group
Participants assigned to this arm will not receive the mobile intervention during the study period. They will complete the same outcome assessments as the intervention group at baseline, post-intervention, and follow-up.
结局指标
主要结局
Change in Misophonia Scale Total Score
时间窗: Baseline, 3 weeks, and 7 weeks
Misophonia symptoms will be assessed using the 30-item Misophonia Scale developed by Koroglu and Durat (2024). Each item is rated on a 5-point Likert scale, yielding a total score ranging from 30 to 150. Higher scores indicate lower misophonia severity, whereas lower scores indicate greater misophonia severity. Changes in total scores will be compared between the intervention and control groups.
次要结局
- Change in DASS-21 Depression Subscale Score(Baseline, 3 weeks, and 7 weeks)
- Change in DASS-21 Anxiety Subscale Score(Baseline, 3 weeks, and 7 weeks)
- Change in DASS-21 Stress Subscale Score(Baseline, 3 weeks, and 7 weeks)
- Change in Difficulties in Emotion Regulation Scale-16 (DERS-16) Total Score(Baseline, 3 weeks, and 7 weeks)
研究者
SEVGI KOROGLU
Research Assistant
Sakarya University