Virtual ACT for Adolescent Stress

Chronic Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04978610
• Other study ID #: CHLA-20-00665
• Status: Suspended
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: January 2024
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 144
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 21 Years

Eligibility

Inclusion Criteria for Children:

1. Children who are English speaking

2. 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).

3. Children with access to a device with internet and webcam capabilities

4. Children with access to a private setting to participate in the intervention

Inclusion criteria for caregivers:

1. Must be 18 years or older and legal guardian of enrolled child

2. English or Spanish speaking, with an ability to read in their language

Exclusion criteria for children:

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness

Intervention

Behavioral:
• Virtual Acceptance Commitment Therapy
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.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (26)

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rodriguez EM, Dunn MJ, Zuckerman T, Vannatta K, Gerhardt CA, Compas BE. Cancer-related sources of stress for children with cancer and their parents. J Pediatr Psychol. 2012 Mar;37(2):185-97. doi: 10.1093/jpepsy/jsr054. Epub 2011 Aug 13. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Trompetter HR, Bohlmeijer ET, Veehof MM, Schreurs KM. Internet-based guided self-help intervention for chronic pain based on Acceptance and Commitment Therapy: a randomized controlled trial. J Behav Med. 2015 Feb;38(1):66-80. doi: 10.1007/s10865-014-9579-0. Epub 2014 Jun 13. — View Citation

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. — View Citation

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. — View Citation

Wicksell RK, Melin L, Lekander M, Olsson GL. Evaluating the effectiveness of exposure and acceptance strategies to improve functioning and quality of life in longstanding pediatric pain--a randomized controlled trial. Pain. 2009 Feb;141(3):248-257. doi: 10.1016/j.pain.2008.11.006. Epub 2008 Dec 23. — View Citation

Wicksell RK, Olsson GL, Hayes SC. Mediators of change in acceptance and commitment therapy for pediatric chronic pain. Pain. 2011 Dec;152(12):2792-2801. doi: 10.1016/j.pain.2011.09.003. Epub 2011 Oct 11. — View Citation

Witlox M, Kraaij V, Garnefski N, de Waal MWM, Smit F, Hoencamp E, Gussekloo J, Bohlmeijer ET, Spinhoven P. An Internet-based Acceptance and Commitment Therapy intervention for older adults with anxiety complaints: study protocol for a cluster randomized controlled trial. Trials. 2018 Sep 17;19(1):502. doi: 10.1186/s13063-018-2731-3. — View Citation

Woidneck MR, Morrison KL, Twohig MP. Acceptance and Commitment Therapy for the Treatment of Posttraumatic Stress Among Adolescents. Behav Modif. 2014 Jul;38(4):451-76. doi: 10.1177/0145445513510527. Epub 2013 Nov 20. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	baseline at the start of study and change from baseline at 6 weeks
Secondary	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.	baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks
Secondary	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.	baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks
Secondary	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.	baseline at the start of study and change from baseline at 6 weeks
Secondary	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.	baseline at the start of study and change from baseline at 6 weeks
Secondary	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.	baseline at the start of study and change from baseline at 6 weeks
Secondary	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	baseline at the start of study and change from baseline at 6 weeks