Virtual Acceptance Commitment Therapy (ACT): A Randomized Controlled Trial to Evaluate a Web-Based Intervention for Stress in Adolescents With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Assess Change via the Perceived Stress Scale (PSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Children:
- •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
- •Inclusion criteria for caregivers:
- •Must be 18 years or older and legal guardian of enrolled child
- •English or Spanish speaking, with an ability to read in their language
排除标准
- •for children:
- •1. Known developmental delay that precludes the ability to complete questionnaires or participate in group therapy
研究组 & 干预措施
Intervention (Immediate)
Participants 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.
干预措施: Virtual Acceptance Commitment Therapy (Behavioral)
Control (Waitlist)
Upon 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.
干预措施: Virtual Acceptance Commitment Therapy (Behavioral)
结局指标
主要结局
Assess Change via the Perceived Stress Scale (PSS)
时间窗: 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
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.
次要结局
- Assess Change via the Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 v2.0 (PROMIS-25)(baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks)
- Assess Change via the Brief Experiential Avoidance Questionnaire (BEAQ)(baseline at the start of study and change from baseline at 6 weeks)
- Assess Change via the Faces Pain Scale-Revised (FPS-R)(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)
- Assess Change via the Behavior Assessment System for Children, Third Edition (BASC-3)(baseline at the start of study and change from baseline at 6 weeks)
- Assess Change via the Acceptance and Action Questionnaire (AAQ-II)(baseline at the start of study and change from baseline at 6 weeks)
- Assess Change via the Comprehensive Adolescent Severity Inventory (CASI)(baseline at the start of study, change from baseline at 6 weeks, change from baseline at 10 weeks, change from baseline at 18 weeks)
- Assess Change via Avoidance and Fusion Questionnaire Youth (AFQ-Y)(baseline at the start of study and change from baseline at 6 weeks)
- Assess Change via the Child and Adolescent Mindfulness Measure (CAMM)(baseline at the start of study and change from baseline at 6 weeks)
研究者
Jeffrey I Gold, PhD
Principal Investigator
Children's Hospital Los Angeles