Evaluating an Online Acceptance and Commitment Training Program for Individuals With Chronic Health Conditions

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

Official Title
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Preliminary Evaluation of an Online Acceptance and Commitment Training Program for Individuals With Chronic Health Conditions

Conditions
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Stress, Psychological, Depression, Well-Being, Psychological

Intervention / Treatment
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* Behavioral: ACT Guide for Chronic Health Conditions


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Following random assignment to the condition after completing baseline assessment, participants will be instructed to complete the ACT Guide for Chronic Health Conditions program over the next 6 weeks. | Behavioral: ACT Guide for Chronic Health Conditions<br>* Acceptance and commitment therapy (ACT) combines the skills of acceptance, cognitive defusion, being present, self as context, values, and committed action to help individuals engage with a meaningful life. The current project is an online, self-guided, 6-session intervention based on ACT. The program is intended to help individuals with chronic health conditions improve their quality of life and mental health. Each session is expected to take about 30 minutes each, and the entire program will take 6 weeks to complete, as users will be encouraged to work on one session per week. Within each session, participants will read about concepts and ACT metaphors, apply ACT concepts to general and chronic health condition specific vignettes, and apply ACT concepts to their own lives and situations related to their chronic health condition. Interactive experiences are included in each session and ends with a printable summary with practice skills before proceeding.<br>|
| No Intervention: Waitlist Control<br>Following random assignment to the condition after completing baseline assessment, participants will be instructed to wait to receive the intervention after a period of 10 weeks (this accounts for the 6 weeks that treatment condition participants are given to complete the program, plus the 4 interim between post-assessment and follow-up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Continuum - Short Form (MHC-SF; to assess positive mental health) | 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. | baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CompACT (to assess psychological flexibility) | This 23-item measure will be used to measure the ACT process of change, psychological flexibility, including subscales for openness to experience, behavioral awareness, and valued action. The CompACT will serve as the primary outcome for this study in order to test whether a single session intervention is sufficient to target the ACT process of change of psychological flexibility. The scale uses 7-point Likert scale ranging from 0 to 6, with total score ranging from 0 to 138. A higher score indicates a better outcome. | 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) | The 5-item Work and Social Adjustment Scale (WSAS; Mundt et al., 2002) assesses the degree to which chronic health conditions interfere with psychosocial functioning (e.g., ability to work, complete home tasks). The scale uses 9-point Likert scale ranging from 0 to 8, with total score ranging from 0 to 40. A higher score indicates a worse outcome. | baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline) | 
| Depression, Anxiety and Stress Scale (DASS-21) | This 21-item measure will be used to assess the subscales of depression, anxiety, and stress, with a total score representing overall psychological distress. The scale uses 4-point Likert scale ranging from 0 to 3. To calculate the total score, the score for each individual item is doubled. The total score ranges from 0 to 126, and each of the three subscales ranges from 0 to 42. A higher score indicates a worse outcome. | baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline) | 
| Program satisfaction (Responses to a series of single item Likert-scale items about satisfaction with the intervention) | A series of program satisfaction items will be asked in the ACT condition immediately post-intervention and at 1-week and 1-month follow up based on items used in our previous online ACT trials. This will include a series of items assessing features of program satisfaction (e.g., overall satisfaction, helpfulness, perceived fit, if the program was too short or long, etc…) on a scale from 1 (strongly disagree) to 6 (strongly agree). These are not intended to be summed for a total score. Whether a higher or lower score is more desirable depends on the individual item. In addition, participants will be asked to type responses to open ended questions assessing what they learned from the program and areas needing further revision. | post-assessment (6 weeks after baseline) | 
| System usability scale (SUS; to measure program usability) | At posttreatment only, participants will be asked to rate their perception of the ACT program's usability using the System Usability Scale. This measure consists of 10 items assessing program usability. The scale uses 5-point Likert scale ranging from 1 to 5. Scores are transformed to be on a scale that ranges from 0 to 100. A higher score indicates a better outcome. | post-assessment (6 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acceptance and commitment therapy, chronic health conditions