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临床试验/NCT06179264
NCT06179264已完成不适用

Preliminary Evaluation of an Online Acceptance and Commitment Training Program for Individuals with Chronic Health Conditions

Utah State University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2024年1月26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
101
试验地点
2
主要终点
Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health)

研究概览

简要总结

Chronic health conditions (CHC) commonly share the challenge of impaired health-related quality of life, negatively impacting the lives of millions of people in the United States. Long term effects for living with a chronic health condition are likely to include poor self-management behaviors, which are related to avoidance of disease related thoughts and feelings (e.g., health anxiety) and can be addressed directly with psychosocial interventions. With the focus on fostering values driven and meaningful behavior while accepting thoughts and feelings, ACT may prove to be a particularly effective approach for individuals coping with the challenging symptoms and effects of having a chronic health condition. Previous web-based ACT interventions for CHCs have focused on building ACT skills for a narrow subset of CHCs (e.g., breast cancer, diabetes, tinnitus). While there is added benefit for a self-help program for populations with specific stressors or conditions, there is also a high prevalence of comorbidity in CHCs, shared challenges in illness management and coping, and clear evidence that ACT works effectively across CHCs to improve quality of life. Thus, our goal of this research project is to evaluate a new 6 session, online, self-guided ACT program for adults with chronic health conditions broadly to improve their quality of life and wellbeing through a randomized controlled trial. The specific aims are:

  1. To evaluate the feasibility of an initial prototype of ACT program for adults with CHC's as indicated by recruitment, retention, and adherence rates.
  2. To evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion.
  3. To identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback.
  4. To test the efficacy of the program on improving quality of life among adults with CHC's.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • ≥ 18 years old
  • Currently living in the U.S.
  • Self-report having at least 1 chronic health condition (e.g., cardiovascular disease, cancer, diabetes, chronic pain, rheumatoid arthritis, HIV, Parkinson's disease, irritable bowel syndrome, Crohn's disease, chronic obstructive pulmonary disease, multiple sclerosis)
  • Self-report having had the chronic health condition for ≥ 3 months
  • Can access the internet via computer, mobile phone, or tablet
  • Have an interest in using an online mental health intervention

排除标准

  • Not fluent in reading English (at this point the online program can only be feasibly and competently delivered in English)

结局指标

主要结局

Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health)

时间窗: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)

This 14-item measure assesses positive mental health, with a total score as well as subscales for emotional, psychological and social wellbeing. The scale uses 6-point Likert scale ranging from 0 "never" to 5 "everyday." Items are summed, yielding a total score ranging from 0 to 70. A higher score indicates a better outcome.

次要结局

  • CompACT (to assess psychological flexibility)(baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline))
  • Work and Social Adjustment Scale (WSAS; to assess psychosocial functioning as impacted by chronic health conditions)(baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline))
  • Depression, Anxiety and Stress Scale (DASS-21)(baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline))
  • System usability scale (SUS; to measure program usability)(post-assessment (6 weeks after baseline))
  • Program satisfaction (Responses to a series of single item Likert-scale items about satisfaction with the intervention)(post-assessment (6 weeks after baseline))

研究者

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

Michael Levin

Professor of Psychology

Utah State University

研究点 (2)

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