跳至主要内容
临床试验/NCT07220941
NCT07220941招募中不适用

Efficacy and Feasibility of an Online Acceptance Based Intervention for Misophonia: A Randomized Controlled Trial

Utah State University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Selective Sound Sensitivity Syndrome Scale (S-Five; Vitoratou et al., 2021)

研究概览

简要总结

The goal of this clinical trial is to test an online intervention for adults with misophonia. The main questions it aims to answer are:

  1. Is the online intervention effective, compared to a waitlist control condition?
  2. Is the online intervention acceptable to use?

Participants will be randomized into either the online intervention or waitlist control condition:

  1. Participants in the intervention condition will be asked to complete an 8 module acceptance and commitment therapy (ACT) program for misophonia and 5 surveys over 4 months.
  2. Participants in the waitlist condition will be asked to complete 5 surveys over 4 months, and will receive access to the intervention once the study is complete.

详细描述

Misophonia, characterized by intense emotional reactions to specific sounds, significantly impacts daily functioning and quality of life. Acceptance and Commitment Therapy (ACT) has shown promise in addressing misophonia symptoms by fostering psychological flexibility. While recent intervention studies demonstrate the efficacy of ACT for misophonia, accessible and scalable treatment options remain scarce. This study aims to address this gap by developing and evaluating a fully automated, online ACT-based digital mental health intervention for misophonia. We will compare the intervention to a delayed treatment group in a sample of 100 adults meeting clinical criteria for misophonia. Outcomes will include misophonia symptoms, quality of life, general distress, and psychological flexibility, assessed at baseline, mid-intervention, post-intervention, and one- and two-month follow-up. Multilevel modeling will test time by condition interactions to examine the efficacy and feasibility of an online ACT-based intervention. This fully automated online intervention aims to provide accessible, evidence-based treatment for individuals with misophonia, laying groundwork for future, larger-scale studies and public dissemination.

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

入选标准

  • Currently meet clinical impairment for misophonia.
  • At least 18 years old.
  • Fluent English speakers.
  • Currently live or reside in the United States

排除标准

  • Currently receiving alternative psychotherapy for misophonia.
  • Currently modifying or starting psychotropic medication (within 30 days of starting the study).
  • Any psychological and/or neurological impairments that would preclude someone from participating in the study (e.g.,active self-harm or psychosis)

结局指标

主要结局

Selective Sound Sensitivity Syndrome Scale (S-Five; Vitoratou et al., 2021)

时间窗: 16 weeks

The S-Five is a 25-item self-report measure of misophonia severity. Items (e.g., "I feel trapped if I cannot get away from certain noises") are rated on a 0 (not at all true) to 10 (completely true) ordinal scale with total scores ranging from 0 to 250. The S-Five consists of five latent factors: (1) externalizing appraisals (e.g., blaming others for making sounds), (2) internalizing appraisals (e.g., negative self-judgments triggered by misophonia), (3) impact on functioning (e.g., social and occupational impact), (4) outburst (e.g., experiences of aggression or fear of losing control), and (5) threat (e.g., feeling trapped or helpless). The S-Five demonstrates good internal consistency and convergent validity with other misophonia measures (Vitoratou et al., 2023).

次要结局

  • Misophonia acceptance and action questionnaire (Miso-AAQ; Capel et al., 2025)(16 weeks)
  • Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT; Francis et al., 2016)(16 weeks)
  • Depression Anxiety Stress Scale (DASS-21; Lovibond & Lovibond, 1995)(16 weeks)
  • Mental Health Continuum-Short Form (MHC-SF; Keyes, 2005)(16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验