NCT04978610

Virtual ACT for Adolescent Stress

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 14 Years – 21 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-03
• Primary completion: 2026-03-04
• Completion: 2026-03-04
• First posted: 2021-07-27
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States