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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06179264
• Other study ID #: IRB: #13890
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: May 15, 2025

Study information

• Verified date: May 2024
• Source: Utah State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: May 15, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Stress, Psychological

Intervention

Behavioral:
• ACT Guide for Chronic Health Conditions
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.

Locations

Country	Name	City	State
United States	Utah State University	Logan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Utah State University

Country where clinical trial is conducted

United States, 

References & Publications (11)

Bangor, A., Kortum, P. T., & Miller, J. T. (2008). An empirical evaluation of the system usability scale. Intl. Journal of Human-Computer Interaction, 24(6), 574-594.

Dindo L, Van Liew JR, Arch JJ. Acceptance and Commitment Therapy: A Transdiagnostic Behavioral Intervention for Mental Health and Medical Conditions. Neurotherapeutics. 2017 Jul;14(3):546-553. doi: 10.1007/s13311-017-0521-3. — View Citation

Feliu-Soler A, Montesinos F, Gutierrez-Martinez O, Scott W, McCracken LM, Luciano JV. Current status of acceptance and commitment therapy for chronic pain: a narrative review. J Pain Res. 2018 Oct 2;11:2145-2159. doi: 10.2147/JPR.S144631. eCollection 2018. — View Citation

Francis, A. W., Dawson, D. L., & Golijani-Moghaddam, N. (2016). The development and validation of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT). Journal of Contextual Behavioral Science, 5(3), 134-145.

Grady PA, Gough LL. Self-management: a comprehensive approach to management of chronic conditions. Am J Public Health. 2014 Aug;104(8):e25-31. doi: 10.2105/AJPH.2014.302041. Epub 2014 Jun 12. — View Citation

Graham CD, Gouick J, Krahe C, Gillanders D. A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clin Psychol Rev. 2016 Jun;46:46-58. doi: 10.1016/j.cpr.2016.04.009. Epub 2016 Apr 20. — View Citation

Herbert MS, Dochat C, Wooldridge JS, Materna K, Blanco BH, Tynan M, Lee MW, Gasperi M, Camodeca A, Harris D, Afari N. Technology-supported Acceptance and Commitment Therapy for chronic health conditions: A systematic review and meta-analysis. Behav Res Ther. 2022 Jan;148:103995. doi: 10.1016/j.brat.2021.103995. Epub 2021 Nov 12. — View Citation

Lamers SM, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL. Evaluating the psychometric properties of the Mental Health Continuum-Short Form (MHC-SF). J Clin Psychol. 2011 Jan;67(1):99-110. doi: 10.1002/jclp.20741. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u. — View Citation

Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461. — View Citation

Samiei Siboni F, Alimoradi Z, Atashi V, Alipour M, Khatooni M. Quality of Life in Different Chronic Diseases and Its Related Factors. Int J Prev Med. 2019 May 17;10:65. doi: 10.4103/ijpvm.IJPVM_429_17. eCollection 2019. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)