Clinical trial NCT06179264: Evaluating an Online Acceptance and Commitment Training Program for Individuals with Chronic Health Conditions
Official title: Preliminary Evaluation of an Online Acceptance and Commitment Training Program for Individuals with Chronic Health Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Depression
Well-Being, Psychological
Keywords: acceptance and commitment therapy
chronic health conditions
Lead sponsor: Utah State University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized wait list control trial. Parallel assignment of participants to treatment and wait list groups. Wait list participants receive treatment after 10 weeks of waiting. Treatment participants receive treatment immediately.
Primary purpose: SUPPORTIVE_CARE

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.


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)

Primary outcomes:
measure: Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health)
timeFrame: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)
Secondary outcomes:
measure: CompACT (to assess psychological flexibility)
timeFrame: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)
measure: Work and Social Adjustment Scale (WSAS; to assess psychosocial functioning as impacted by chronic health conditions)
timeFrame: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)
measure: Depression, Anxiety and Stress Scale (DASS-21)
timeFrame: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)
measure: Program satisfaction (Responses to a series of single item Likert-scale items about satisfaction with the intervention)
timeFrame: post-assessment (6 weeks after baseline)
measure: System usability scale (SUS; to measure program usability)
timeFrame: post-assessment (6 weeks after baseline)
Other outcomes:
Locations:
city: Logan
country: United States
facility: Utah State University
state: Utah
Study officials:
affiliation: Utah State University
name: Michael E Levin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Utah State University
name: Ty B Aller
role: STUDY_DIRECTOR
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