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

NCT06179264 | Completed

• 1 other identifier: IRB: #13890
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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. 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. 2.To evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion.
3. 3.To identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback.
4. 4.To test the efficacy of the program on improving quality of life among adults with CHC's.

Conditions

Stress, Psychological; Depression; Well-Being, Psychological

Keywords

acceptance and commitment therapy; chronic health conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

• Program satisfaction (Responses to a series of single item Likert-scale items about satisfaction with the intervention)

  post-assessment (6 weeks after baseline)

• System usability scale (SUS; to measure program usability)

  post-assessment (6 weeks after baseline)

Study Arms (2)

Treatment

EXPERIMENTAL

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

Waitlist Control

NO INTERVENTION

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.

Interventions

ACT Guide for Chronic Health Conditions BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Utah State University: lead

Study Sites (1)

Utah State University

Logan, Utah, 84322, United States

Location

Related Publications (12)

• 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.

  PMID: 28271287 BACKGROUND

• 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.

  PMID: 30323649 BACKGROUND

• 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.

  PMID: 24922170 BACKGROUND

• 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.

  PMID: 27176925 BACKGROUND

• 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.

  PMID: 34800873 BACKGROUND

• 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.

  PMID: 31198500 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 20973032 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  PMID: 11983645 BACKGROUND

• Levin ME, Aller TB, Klimczak KS, Donahue ML, Knudsen FM. Digital acceptance and commitment therapy for adults with chronic health conditions: Results from a waitlist-controlled trial. Behav Res Ther. 2025 May;188:104729. doi: 10.1016/j.brat.2025.104729. Epub 2025 Mar 16.

  PMID: 40120228 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Michael E Levin, PhD

  Utah State University

  PRINCIPAL INVESTIGATOR

• Ty B Aller

  Utah State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: January 26, 2024
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: March 28, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Dr. Michael Levin or Dr. Aller will review requests and criteria.

Locations

US (1)