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Stress, PsychologicalNCT06179264

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

A study testing ACT Guide for Chronic Health Conditions in people with Stress, Psychological and Depression, run by Utah State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
ACT Guide for Chronic Health Conditions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteUnited States
Study dates
26 Jan 2024to 17 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Utah State University

    Logan, Utah, 84322

Other trials in United States

About this study

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

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.
Being tested
ACT Guide for Chronic Health Conditions
Keywords
acceptance and commitment therapy, chronic health conditions
Medical subject headings
Stress, Psychological, Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT Guide for Chronic Health ConditionsBehavioural

    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.

Study groups in NCT06179264
Study groupRoleWhat they receive
TreatmentExperimentalFollowing 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.
Receives: Behavioral: ACT Guide for Chronic Health Conditions
Waitlist ControlNo interventionFollowing 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 being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)

Secondary outcomes (5)

  1. 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.

    Measured: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)

  2. 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.

    Measured: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)

  3. 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.

    Measured: baseline, post-assessment (6 weeks after baseline), follow-up (10 weeks after baseline)

  4. 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.

    Measured: post-assessment (6 weeks after baseline)

  5. 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.

    Measured: post-assessment (6 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start26 Jan 2024
  3. Primary completion17 Sep 2024
  4. Study completion17 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179264
Sponsor's protocol ID
IRB: #13890
Status last verified
May 2024
First submitted
11 Dec 2023
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Publications

  • 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.

    PubMed 28271287

  • 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.

    PubMed 30323649

  • 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.

    PubMed 24922170

  • 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.

    PubMed 27176925

  • 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.

    PubMed 34800873

  • 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.

    PubMed 31198500

  • 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.

  • 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.

  • 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.

    PubMed 20973032

  • 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.

    PubMed 7726811

  • 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.

    PubMed 11983645

  • 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.

    PubMed 40120228

Questions about this trial

What is this clinical trial studying?

A study testing ACT Guide for Chronic Health Conditions in people with Stress, Psychological and Depression, run by Utah State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06179264, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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