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Clinical Trials/NCT06179264
NCT06179264
Completed
Not Applicable

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

Utah State University1 site in 1 country101 target enrollmentJanuary 26, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
Utah State University
Enrollment
101
Locations
1
Primary Endpoint
Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
January 26, 2024
End Date
September 17, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Levin

Professor of Psychology

Utah State University

Eligibility Criteria

Inclusion Criteria

  • ≥ 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (1)

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