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临床试验/NCT03709433
NCT03709433已完成不适用

An ACT Skills Group and Mobile App for Worry

Utah State University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Penn State Worry Questionnaire (PSWQ)

研究概览

简要总结

This study is an open trial of acceptance and commitment therapy (ACT) groups combined with a mobile app for the treatment of Generalized Anxiety Disorder (GAD). The goal of this study is to evaluate if ACT groups and a mobile app are efficacious and acceptable in the treatment of GAD.

Study hypotheses are:

  1. Group ACT will lead to improvement in worry, anxiety, comorbid depression, functioning, and well-being.
  2. Group ACT will also lead to improvement in theoretically relevant processes, namely psychological inflexibility, anxiety-related fusion, mindfulness, and progress towards values.
  3. Combining a mobile app with group ACT will be credible, acceptable, and satisfactory to participants.

详细描述

Participants and power:

Each group will include 6-12 participants. The target sample size is 36 participants, which would provide good power (0.90) to detect a medium effect size in a repeated-measures ANOVA with three time points and requires running at least 3 groups.

All clinics on the Utah State University campus will be asked to refer their waitlist clients to the group, if appropriate (e.g., client presented with significant worry). Local private practitioners in the Cache Valley, Utah area may also be notified about the option to refer their waitlist clients to the group. Fliers will be posted on the Utah State University campus and in the local community and distributed to providers to provide more information on the study. Fliers will direct interested individuals to contact the researchers. The study will also be listed on the Utah State University Contextual Behavioral Science Lab website with a link to the pre-screening.

Procedures:

Individuals who contact the researchers expressing interest will be sent more information on study procedures and asked to complete a brief online pre-screening specific to this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

No masking will be used.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Penn State Worry Questionnaire (PSWQ)

时间窗: At posttreatment (6-10 weeks after baseline)

The PSWQ is a 16-item self-report measure of problematic worry. The PSWQ has validity and reliability in clinical samples.

次要结局

  • Valuing Questionnaire (VQ) - Progress subscale(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Credibility/Expectancy Questionnaire (CEQ)(At the end of the first group therapy session, 0-4 weeks after baseline)
  • Penn State Worry Questionnaire (PSWQ)(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Mental Health Continuum-Short Form (MHC-SF)(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • State-Trait Anxiety Inventory (STAI) - Trait Subscale(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Beck Depression Inventory-II (BDI-II)(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Acceptance and Action Questionnaire (AAQ-II)(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Believability of Anxious Thoughts and Feelings (BAFT) Questionnaire(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Mindful Attention Awareness Scale (MAAS)(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • PROMIS 8a Satisfaction with Social Roles and Activities(One month after the posttreatment survey is administered (10-14 weeks after baseline))
  • Mobile app question: "How much are you....Feeling nervous, anxious, or on edge"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)
  • Mobile app question: "How much are you....Fighting your feelings"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)
  • Mobile app question: "How much are you....Disconnected from values"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)
  • Treatment Evaluation Inventory-Short Form (TEI-SF)(At posttreatment (6-10 weeks after baseline))
  • Novel satisfaction items(At posttreatment (6-10 weeks after baseline))
  • Mobile app question: "How much are you....Worrying too much about different things"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)
  • Mobile app question: "How much are you....Feeling down, depressed, or hopeless"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)
  • Mobile app question: "How much are you....Stuck in thoughts"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)
  • Mobile app question: "How much are you....Running on autopilot"(Each time participants use the mobile app (intervention and follow-up period). This time period will begin 0-4 weeks after baseline and end 10-14 weeks after baseline.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Twohig, Ph.D.

Professor

Utah State University

研究点 (2)

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