Study Summary
This trial will test if a 6-week online group therapy can help improve symptoms for teens with chronic illnesses, compared to no treatment.
Eligible Conditions
- Chronic Illness
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks
Week 6
Assess Change via Avoidance and Fusion Questionnaire Youth (AFQ-Y)
Assess Change via the Acceptance and Action Questionnaire (AAQ-II)
Assess Change via the Behavior Assessment System for Children, Third Edition (BASC-3)
Assess Change via the Brief Experiential Avoidance Questionnaire (BEAQ)
Assess Change via the Child and Adolescent Mindfulness Measure (CAMM)
Week 18
Assess Change via the Comprehensive Adolescent Severity Inventory (CASI)
Assess Change via the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 v2.0 (PROMIS-25)
Week 18
Assess Change via the Faces Pain Scale-Revised (FPS-R)
Assess Change via the Perceived Stress Scale (PSS)
Trial Safety
Trial Design
1 Treatment Group
Intervention (Immediate)
1 of 1
Experimental Treatment
144 Total Participants · 1 Treatment Group
Primary Treatment: Virtual Acceptance Commitment Therapy · No Placebo Group · N/A
Intervention (Immediate)
Behavioral
Experimental Group · 1 Intervention: Virtual Acceptance Commitment Therapy · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks
Who is running the clinical trial?
Children's Hospital Los AngelesLead Sponsor
207 Previous Clinical Trials
5,071,603 Total Patients Enrolled
Jeffrey Gold, PhDPrincipal InvestigatorChildren's Hospital Los Angeles
Nicole Mahrer, PhDPrincipal InvestigatorChildren's Hospital Los Angeles
Eligibility Criteria
Age 14 - 21 · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Children must have a private place to participate in the study.
You can speak and read in English or Spanish.
Only children who speak English will be included.
Children with long-term illnesses that require ongoing medical attention or affect their daily activities (excluding obesity) are not eligible.
You have a computer or device with internet and webcam to participate in the study.
You must be 18 years or older to participate, or the legal guardian of a child who is enrolled.
References
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- 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.
- Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43.
- 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.
- 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.
- Scott W, Chilcot J, Guildford B, Daly-Eichenhardt A, McCracken LM. Feasibility randomized-controlled trial of online Acceptance and Commitment Therapy for patients with complex chronic pain in the United Kingdom. Eur J Pain. 2018 Apr 28. doi: 10.1002/ejp.1236. Online ahead of print.
- Sansom-Daly UM, Peate M, Wakefield CE, Bryant RA, Cohn RJ. A systematic review of psychological interventions for adolescents and young adults living with chronic illness. Health Psychol. 2012 May;31(3):380-93. doi: 10.1037/a0025977. Epub 2011 Nov 7.
- 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.
- 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.
- Sawyer MG, Reynolds KE, Couper JJ, French DJ, Kennedy D, Martin J, Staugas R, Ziaian T, Baghurst PA. Health-related quality of life of children and adolescents with chronic illness--a two year prospective study. Qual Life Res. 2004 Sep;13(7):1309-19. doi: 10.1023/B:QURE.0000037489.41344.b2.
- Waters E, Davis E, Nicolas C, Wake M, Lo SK. The impact of childhood conditions and concurrent morbidities on child health and well-being. Child Care Health Dev. 2008 Jul;34(4):418-29. doi: 10.1111/j.1365-2214.2008.00825.x.
- 2021. "Virtual ACT for Adolescent Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978610.
Frequently Asked Questions
Does this experiment include geriatric patients in its sample size?
"This study is looking for 14-21 year olds to participate." - Anonymous Online Contributor
Unverified Answer
Are there still spots available in this clinical trial for new patients?
"According to the most recent information available on clinicaltrials.gov, this clinical trial is still searching for patients. The trial was originally posted on March 3rd, 2021 and was last edited on July 26th, 2021. The trial is searching for 144 patients at 1 site." - Anonymous Online Contributor
Unverified Answer
Are there any ineligibility requirements for potential participants of this research?
"This study needs 144 young participants, aged 14-21, who have chronic diseases. Other requirements for potential patients include: a diagnosis of a chronic illness (which must last for at least a year and require regular medical care or limit normal activities), being able to speak English, having a device with internet and webcam capabilities, being able to have private sessions for the study, and being 18 years or older (with the legal guardian's permission)." - Anonymous Online Contributor
Unverified Answer