AzTrials
AzTrials

Chronic IllnessNCT04978610

Virtual ACT for Adolescent Stress

A study testing Virtual Acceptance Commitment Therapy in people with Chronic Illness, run by Children's Hospital Los Angeles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study aims to test the effectiveness of a 6-week long virtual Acceptance Commitment group therapy as a non-pharmaceutical intervention to improving other functional outcomes for adolescents with a chronic medical condition in comparison to no treatment. Read more about this study

Who is it for?
Ages 14 to 21 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Illness
What is being tested?
Virtual Acceptance Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
3 Mar 2021to 4 Mar 2026
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 14 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Children who are English speaking
  • Children who are diagnosed with a chronic illness: Defined as a condition that lasts 1 year or more and requires ongoing medical attention or limits activities of daily living or both (excluding obesity).
  • Children with access to a device with internet and webcam capabilities
  • Children with access to a private setting to participate in the intervention
  • Must be 18 years or older and legal guardian of enrolled child
  • English or Spanish speaking, with an ability to read in their language

Who cannot join

  • 1. Known developmental delay that precludes the ability to complete questionnaires or participate in group therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

Other trials in United States

About this study

Official title: Virtual Acceptance Commitment Therapy (ACT): A Randomized Controlled Trial to Evaluate a Web-Based Intervention for Stress in Adolescents With Chronic Conditions

This study aims to test the effectiveness of a 6-week long virtual Acceptance Commitment group therapy as a non-pharmaceutical intervention to improving other functional outcomes for adolescents with a chronic medical condition in comparison to no treatment.

Read the detailed description

Upwards of 40% of children and adolescents/young adults (AYAs) in the United States suffer from at least one chronic medical condition, excluding obesity. The emotional and psychological burden of having a chronic condition in youth can lead this population to experience higher rates of stress, depression, and anxiety in addition to reduced health-related quality of life compared to their healthy peers. Acceptance and Commitment Therapy (ACT) is an intervention that teaches skills such as psychological flexibility, mindfulness, and cognitive defusion that has been shown to significantly improve psychological outcomes and quality of life among children and AYAs with chronic conditions. Few studies, however, have examined the efficacy of this intervention in reducing stress among children and AYAs with chronic conditions delivered in a group, web-based format. The need for virtually administered psychological interventions is especially salient amidst the Covid-19 pandemic as CDC guidelines discourage in-person gatherings and close contact with others. The current study aims to: 1) Determine if a web-based group ACT intervention of 6 sessions is more effective than no intervention (waitlist control) in reducing stress among children and AYAs with chronic conditions, 2) Determine if a web-based group ACT intervention of 6 sessions is more effective than no intervention in improving other functional outcomes among children and AYAs with chronic conditions, 3) Evaluate if a web-based group ACT intervention of 6 sessions improves participants skills in psychological flexibility, mindfulness, and cognitive defusion. Study population: Children and Adolescents/Young Adults (ages 14-21) diagnosed with a chronic medical condition seeking care at Children's Hospital Los Angeles, who are in the normal range of development and are eligible to participate in the study. Study Methodology: The study is a non-blinded, randomized, controlled trial designed to examine the effect of a web-based group ACT intervention on stress, depression, anxiety, health-related quality of life, and adaptive psychological skills in children and AYAs with chronic conditions. Statistical analysis: The primary analysis will involve a two independent samples t-test to compare the mean 6-week PSS scores between the two treatment groups. Secondary analyses will compare treatment groups on other study outcomes.

Conditions
Chronic Illness
Being tested
Virtual Acceptance Commitment Therapy
Keywords
Virtual Therapy, Group Therapy, Chronic Medical Condition, Adolescent
Medical subject headings
Chronic Disease

What participants receive

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

  • Virtual Acceptance Commitment TherapyBehavioural

    For a period of 6 continuous weeks, participants will meet weekly in a virtual group ACT session with a licensed psychologist hosted on a secure, HIPAA compliant, Zoom account. Each session is 1.5 hours will focus on one ACT concept including Acceptance, Values, Mindfulness, Cognitive Defusion, Experiential Avoidance, and Willingness and Committed Action. Subjects will be given the opportunity to share their thoughts as well as their responses to the exercises at various points throughout the sessions.

    At the beginning of each session, each participant will be required to fill out a short survey on their stress and pain the preceding week. Participants in the control group will not complete weekly measures. All measures will be completed online via a REDCap survey web link. Follow up measures will mirror initial baseline measures in order to measure the within group and between group changes in study outcomes.

Study groups in NCT04978610
Study groupRoleWhat they receive
Intervention (Immediate)ExperimentalParticipants in the intervention group will begin their 6-week vACT sessions first and complete baseline, the weekly surveys during intervention, post, one month follow-up, and three month follow-up.
Receives: Behavioral: Virtual Acceptance Commitment Therapy
Control (Waitlist)OtherUpon the intervention group's completion of the 6-week long vACT, the control group will then enroll into their own 6-week long ACT intervention. The research protocol for the second 6-week long ACT intervention will mirror the protocol with the original 6-week long ACT intervention, except for one change: participants will NOT complete an additional baseline questionnaire prior to starting the 6-week ACT therapy group. The rest of the protocol remains the same. Namely, before each session, each participant will be required to fill out a short survey on their stress and pain throughout previous week. At the conclusion of the final session, participants will follow the complete post-intervention battery of surveys, which mirrors the baseline measures plus the inclusion of satisfaction surveys assessing the effectiveness of the virtual therapy intervention. Participants will complete the post-intervention follow up battery of questionnaires at 1 and 3 months post-intervention.
Receives: Behavioral: Virtual Acceptance Commitment Therapy

What is being measured

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

  1. Assess Change via the Perceived Stress Scale (PSS)

    The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. SS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items and then summing across all scale items with higher scores correlating to more stress. There are ten items total with the minimum value set at 0 and maximum 40 with higher scores correlating to more perceived stress.

    Measured: baseline at the start of study, through study competition (up to 6 weeks), change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

Secondary outcomes (8)

  1. Assess Change via the Faces Pain Scale-Revised (FPS-R)

    Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how the patients are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.

    Measured: baseline at the start of study, through study competition (up to 6 weeks), change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

  2. Assess Change via the Behavior Assessment System for Children, Third Edition (BASC-3)

    Parent Rating Scales (PRS) will be used to asses the child's behaviors and emotions. Parents evaluate 173 items on a never, sometimes, often, almost always scale. This is scored using a computer software purchased through Pearson. The raw score is converted to a T-score based on age and gender. The T-score has a mean of 50 and standard deviation of 10. T-scores above 65 are clinically significant in that domain.

    Measured: baseline at the start of study and change from baseline at 6 weeks

  3. Assess Change via the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 v2.0 (PROMIS-25)

    PROMIS-25 measures quality of life (i.e., depression, anxiety, and pain interference). The 25 items are on a 1-5 scale and are scored using the HealthMeasures Scoring Service with higher scores indicating a lower quality of life.

    Measured: baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

  4. Assess Change via the Comprehensive Adolescent Severity Inventory (CASI)

    This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity.

    Measured: baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks

  5. Assess Change via the Acceptance and Action Questionnaire (AAQ-II)

    This 4-item measure uses 0-4 scale (0 = Not at All True; 4 = Very True) with lower sores correlating with higher psychological flexibility.

    Measured: baseline at the start of study and change from baseline at 6 weeks

  6. Assess Change via Avoidance and Fusion Questionnaire Youth (AFQ-Y)

    This 4-item measure uses 0-4 scale (0 = Not at All True; 4 = Very True) with higher sores correlating with higher psychological inflexibility.

    Measured: baseline at the start of study and change from baseline at 6 weeks

  7. Assess Change via the Child and Adolescent Mindfulness Measure (CAMM)

    This 10-item measure uses a 0-4 scale (0 = Not at All True; 4 = Very True) with lower scores correlating to greater mindfulness practices.

    Measured: baseline at the start of study and change from baseline at 6 weeks

  8. Assess Change via the Brief Experiential Avoidance Questionnaire (BEAQ)

    15-item measure uses a 1-6 scale (1= strongly disagree; 6 = strongly agree) with higher scores associated with higher levels of avoidance and psychopathology

    Measured: baseline at the start of study and change from baseline at 6 weeks

Timeline

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

  1. First posted27 Jul 2021
  2. Study start3 Mar 2021
  3. Primary completion4 Mar 2026
  4. Study completion4 Mar 2026

Why it stopped: This study has stopped its recruitment.

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
Crossover
Model description
After informed consent and assent have been obtained and the patient has successfully met the screening criteria, the patient will be enrolled. The study will commence upon the enrollment of approximately 20 participants, at which point participants will be randomized into the Virtual ACT or waitlist (control) group. The intervention group will begin vACT immediately, while the waitlist receive no intervention during the same 6-week time frame. Both groups will take the same baseline questionnaires and post-questionnaires (post, 1 month, and 3 month). After the vACT intervention group finishes, another 6-week vACT session will be offered to the waitlist. The waitlist group will fill out a post-therapy questionnaire again after their 6-weeks. The parents of both groups will fill out a baseline questionnaire and post questionnaires. The investigators will repeat this protocol until 144 participants or 72 caregiver-child dyads.
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04978610
Sponsor's protocol ID
CHLA-20-00665
Status last verified
Apr 2026
First submitted
7 Jul 2021
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bai G, Herten MH, Landgraf JM, Korfage IJ, Raat H. Childhood chronic conditions and health-related quality of life: Findings from a large population-based study. PLoS One. 2017 Jun 2;12(6):e0178539. doi: 10.1371/journal.pone.0178539. eCollection 2017.

    PubMed 28575026

  • Bethell CD, Kogan MD, Strickland BB, Schor EL, Robertson J, Newacheck PW. A national and state profile of leading health problems and health care quality for US children: key insurance disparities and across-state variations. Acad Pediatr. 2011 May-Jun;11(3 Suppl):S22-33. doi: 10.1016/j.acap.2010.08.011.

    PubMed 21570014

  • Buhrman M, Skoglund A, Husell J, Bergstrom K, Gordh T, Hursti T, Bendelin N, Furmark T, Andersson G. Guided internet-delivered acceptance and commitment therapy for chronic pain patients: a randomized controlled trial. Behav Res Ther. 2013 Jun;51(6):307-15. doi: 10.1016/j.brat.2013.02.010. Epub 2013 Mar 14.

    PubMed 23548250

  • Cheng C, Brown RC, Cohen LL, Venugopalan J, Stokes TH, Wang MD. iACT--an interactive mHealth monitoring system to enhance psychotherapy for adolescents with sickle cell disease. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:2279-82. doi: 10.1109/EMBC.2013.6609992.

    PubMed 24110179

  • Compas BE, Jaser SS, Dunn MJ, Rodriguez EM. Coping with chronic illness in childhood and adolescence. Annu Rev Clin Psychol. 2012;8:455-80. doi: 10.1146/annurev-clinpsy-032511-143108. Epub 2011 Dec 20.

    PubMed 22224836

  • Fletcher, L., & Hayes, S. C. (2005). Relational frame theory, acceptance and commitment therapy, and a functional analytic definition of mindfulness. Journal of rational-emotive and cognitive-behavior therapy, 23(4), 315-336.

  • Barnes-Holmes Y, Hayes SC, Barnes-Holmes D, Roche B. Relational frame theory: a post-Skinnerian account of human language and cognition. Adv Child Dev Behav. 2001;28:101-38. doi: 10.1016/s0065-2407(02)80063-5. No abstract available.

    PubMed 11605362

  • Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

    PubMed 16300724

  • Hoffmann D, Rask CU, Hedman-Lagerlof E, Jensen JS, Frostholm L. Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial. Psychol Med. 2021 Nov;51(15):2685-2695. doi: 10.1017/S0033291720001312. Epub 2020 May 14.

    PubMed 32404226

  • Hysing M, Elgen I, Gillberg C, Lie SA, Lundervold AJ. Chronic physical illness and mental health in children. Results from a large-scale population study. J Child Psychol Psychiatry. 2007 Aug;48(8):785-92. doi: 10.1111/j.1469-7610.2007.01755.x.

    PubMed 17683450

  • Lappalainen P, Langrial S, Oinas-Kukkonen H, Tolvanen A, Lappalainen R. Web-based acceptance and commitment therapy for depressive symptoms with minimal support: a randomized controlled trial. Behav Modif. 2015 Nov;39(6):805-34. doi: 10.1177/0145445515598142. Epub 2015 Aug 6.

    PubMed 26253644

  • Moazzezi M, Ataie Moghanloo V, Ataie Moghanloo R, Pishvaei M. Impact of Acceptance and Commitment Therapy on Perceived Stress and Special Health Self-Efficacy in Seven to Fifteen-Year-Old Children With Diabetes Mellitus. Iran J Psychiatry Behav Sci. 2015 Jun;9(2):956. doi: 10.17795/ijpbs956. Epub 2015 Jun 1.

    PubMed 26288639

  • Ataie Moghanloo V, Ataie Moghanloo R, Moazezi M. Effectiveness of Acceptance and Commitment Therapy for Depression, Psychological Well-Being and Feeling of Guilt in 7 - 15 Years Old Diabetic Children. Iran J Pediatr. 2015 Aug;25(4):e2436. doi: 10.5812/ijp.2436. Epub 2015 Aug 24.

    PubMed 26396702

  • Pinquart M, Shen Y. Behavior problems in children and adolescents with chronic physical illness: a meta-analysis. J Pediatr Psychol. 2011 Oct;36(9):1003-16. doi: 10.1093/jpepsy/jsr042. Epub 2011 Aug 1.

    PubMed 21810623

  • Rickardsson J, Zetterqvist V, Gentili C, Andersson E, Holmstrom L, Lekander M, Persson M, Persson J, Ljotsson B, Wicksell RK. Internet-delivered acceptance and commitment therapy (iACT) for chronic pain-feasibility and preliminary effects in clinical and self-referred patients. Mhealth. 2020 Jul 5;6:27. doi: 10.21037/mhealth.2020.02.02. eCollection 2020.

    PubMed 32632365

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Acceptance Commitment Therapy in people with Chronic Illness, run by Children's Hospital Los Angeles 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: stopped early, as of the sponsor's last update on 17 Apr 2026. 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 was stopped early (reason given: This study has stopped its recruitment.). Results are not available in the source record.

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?

Assess Change via the Perceived Stress Scale (PSS) (time frame: baseline at the start of study, through study competition (up to 6 weeks), change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks). 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 NCT04978610, which also lists 26 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 17 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in