Pilot Trial on the Contribution of Peer Leaders and Self-Compassion to Group Exposure Workshops for Socially Anxious Undergraduates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Client Satisfaction Questionnaire-8 (CSQ-8)
研究概览
简要总结
The purpose of the study is to investigate the effects of four versions of a workshop for social anxiety and public speaking stress. All participants are current University of Colorado Boulder undergraduate students. Participation in this research study lasts for approximately 8 weeks, and includes a pre-workshop questionnaire, 3 weekly workshop sessions (ranging from 2 to 3 hours each, including a 5-minute post-session questionnaire), a post-workshop questionnaire, and a 1-month follow-up questionnaire.
详细描述
The present study seeks to evaluate the feasibility, acceptability, and efficacy potential of a full factorial trial of a peer-led common humanity- and exposure-based workshop for social anxiety within a Multiphase Optimization Strategy (MOST) trial framework. The present study seeks to enroll and randomize participants (up to N = 200) by cohort to one of four conditions, reflecting a full factorial trial design. The inclusion of common humanity enhancements and the presence of a peer leader will each serve as independent variables, comprising of the following four study conditions: 1) common humanity with peer leader, 2) common humanity without peer leader, 3) peer leader without common humanity, and 4) exposure only (no common humanity and no peer leader). The investigators will assess outcomes after the workshop sessions (mid1, mid2, mid3, Post[T1]) and one-month following the conclusion of the last workshop session (T2).
The study has the following aims and hypotheses:
Aim 1: To evaluate the feasibility and acceptability of conducting a full factorial trial of a group exposure workshop for social anxiety within a MOST trial framework.
Hypothesis 1a (feasibility): At least 50% of screened, eligible participants will enroll in the study.
Hypothesis 1b (feasibility): Enrolled research participants will attend on average at least 2 out of 3 workshop sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age = 18-30
- •Able to read and write fluently in English
- •Current undergraduate students at CU
- •Experiencing elevated social anxiety symptoms indicated by a SPIN score ≥ 19
- •Experiencing moderate to high communication anxiety indicated by a PRCA- 24 score ≥ 59
- •Open to receiving help for social anxiety or public speaking fears indicated by a help seeking score of ≥ 3 out of 5 (at both screening timepoints as explained below)
- •Able to voluntarily consent to participation
- •Able to participate fully in the study (including in the in-person group workshops and in survey completion) as assessed by screening questions and the study P
排除标准
- •Are currently experiencing moderately severe or severe depression represented by the validated cutoff score for major depression on the PHQ-8 of greater than 14 (Kroenke et al., 2001)
- •Score in the moderate-high range for suicide risk as indicated by the CSSRS (Salvi, 2019), report a suicide attempt in the past 12 months, or report current, ongoing suicidal ideation along with a past (lifetime) suicide attempt
- •Are current students of the PI or clients or current students of the doctoral student co-facilitators
结局指标
主要结局
Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: 48 hours after the final intervention session and 1-month follow-up
Satisfaction with workshops, Range = 8 - 32, Higher scores indicate better outcome (greater satisfaction)
Attendance rate
时间窗: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)
Average number of workshop sessions attended by enrolled research participants.
Enrollment rate
时间窗: Pre-intervention (from screening to enrollment)
Ratio of screened, eligible participants who enrolled in the study.
Liebowitz Social Anxiety Scale (LSAS)
时间窗: 48 hours after the final intervention session and 1-month follow-up
Measure assessing fear/anxiety across a broad range of social and performance situations, Range = 0 - 144, Higher scores indicate worse outcome (worse social anxiety)
Acceptability of Intervention Measure (AIM)
时间窗: 48 hours after the final intervention session and 1-month follow-up
Workshop satisfaction rating, Range = 1 - 5, Higher scores indicate better outcome (greater acceptability)
Social Phobia Inventory (SPIN)
时间窗: 48 hours after the final intervention session and 1-month follow-up
Social anxiety symptom measure, Range = 0 - 68, Higher scores indicate worse outcome (worse social phobia)
次要结局
- Personal Report of Communication Apprehension (PRCA-24)(48 hours after the final intervention session and 1-month follow-up)
- Fidelity(3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart))
- Contamination(3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart))
- Participant Retention(3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart))
- Study Burden(48 hours after the final intervention session and 1-month follow-up)
- Survey Completion(between 10 and 0 days before the first intervention session, 48 hours after the final intervention session, and 1-month follow-up)
- Patient Health Questionnaire-8 (PHQ-8)(48 hours after the final intervention session and 1-month follow-up)
- Self-Compassion Scale - Short (SCS)(48 hours after the final intervention session and 1-month follow-up)
- Stigma and Self-Stigma Scale, help seeking behaviors and self-stigma subscales (SASS)(48 hours after the final intervention session and 1-month follow-up)
- Sense of Belonging Scale(48 hours after the final intervention session and 1-month follow-up)
- Likelihood to Recommend(48 hours after the final intervention session and 1-month follow-up)
- Enjoyableness(48 hours after the final intervention session and 1-month follow-up)
- Provider preference(between 0 and 10 days before the first intervention session, 48 hours after the final intervention session, and 1-month follow-up)
研究者
Joanna Arch
Yvonne Kristy Endowed Chair, Renée Crown Wellness Institute; Professor, Department of Psychology and Neuroscience
University of Colorado, Boulder