Group Exposure Workshops for Socially Anxious Undergraduates
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Group Exposure for Social Anxiety, Self-Compassion Enhanced Group Exposure Therapy for Social Anxiety, Peer-Enhanced Group Exposure Therapy for Social Anxiety, Peer and Self-Compassion Enhanced Group Exposure Therapy for Social Anxiety.
- Кому может быть актуально
- Состояния в реестре: Social Anxiety Disorder, Public Speaking Fear, Public Speaking Anxiety, Social Fear. Базовые параметры: 18 лет — 30 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Pilot Trial on the Contribution of Peer Leaders and Self-Compassion to Group Exposure Workshops for Socially Anxious Undergraduates
Обзор
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.
Подробное описание
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.
Hypothesis 1c (feasibility): Workshops will be delivered with high fidelity (80% of content checklist items covered, on average) and low contamination (20% or less inclusion of content specific to other conditions, on average) in each randomized condition.
Hypothesis 1d (acceptability): Participants will report a median satisfaction with the workshops of 4 or higher on the 1-5 Acceptability of Intervention Measure (AIM).
Hypothesis 1e (acceptability): Participation in the group workshops will be acceptable, indicated by high overall satisfaction with the workshop across conditions (mean rating of \>20 on the Client Satisfaction Questionnaire-8).
Hypothesis 1f (acceptability): ≤20% of participants will report a study burden of 4 or higher on a 1-5 burden measure.
Aim 2: To evaluate the feasibility and efficacy potential of primary and secondary outcomes. Please note that the investigators do not expect to find statistically significant differences between conditions in this pilot study - only patterns of differences in the predicted directions outlined below. This pilot study will establish the foundation for a larger, definitively powered, future trial.
Hypothesis 2a (Feasibility of assessment): At least 70% of participants will complete pre, post, and follow-up surveys.
Hypothesis 2b (Efficacy potential): Compared to the exposure only condition, reliable change magnitudes (Jacobson \& Truax, 1991) will be higher within the peer and compassion-enhanced conditions, with additive effects for the fully enhanced condition, on measures of 1) participant retention, 2) social anxiety, 3) depression, and 4) self-compassion.
Hypothesis 2c (Cultivating community): Compared to the exposure-only condition, reliable change magnitudes will be higher within the peer and compassion-enhanced conditions, with additive effects for the fully enhanced condition, on measures of 1) stigma and 2) sense of belonging.
Hypothesis 2d (Barriers to access and engagement): Compared to the exposure only condition, reliable change magnitudes will be higher in the peer and compassion-enhanced conditions, with additive effects for the fully enhanced condition, on measures of 1) enjoyableness, 2) likelihood to recommend, and 3) readiness and willingness to engage in therapy. Across conditions, participants will indicate a preference for peer co-facilitators over mental health providers only.
Вмешательства
- Поведенческое Group Exposure for Social Anxiety
Group exposure therapy for social anxiety and public speaking fears. - Поведенческое Self-Compassion Enhanced Group Exposure Therapy for Social Anxiety
Group exposure therapy for social anxiety and public speaking fears plus piloted exercises from the investigators' previous studies among socially anxious undergraduates (Slivjak et al., 2022; Slivjak \& Arch, in preparation), refined during the investigators' quality improvement project, that are designed to enhance compassion. - Поведенческое Peer-Enhanced Group Exposure Therapy for Social Anxiety
Group exposure therapy for social anxiety and public speaking fears facilitated by a pair of doctoral student and undergraduate student co-facilitators who explicitly use appropriate self-disclosure to establish the co-facilitators as individuals with lived experiences of social anxiety and public speaking fears. - Поведенческое Peer and Self-Compassion Enhanced Group Exposure Therapy for Social Anxiety
Group exposure therapy for social anxiety and public speaking fears plus piloted exercises from the investigators' previous studies among socially anxious undergraduates (Slivjak et al., 2022; Slivjak \& Arch, in preparation), refined during the investigators' quality improvement project, that are designed to enhance compassion. These groups are facilitated by a pair of doctoral student and undergraduate student co-facilitators who explicitly use appropriate self-disclosure to establish the
Первичные конечные точки
- Attendance rate [Срок оценки: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)]
- Enrollment rate [Срок оценки: Pre-intervention (from screening to enrollment)]
- Acceptability of Intervention Measure (AIM) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Client Satisfaction Questionnaire-8 (CSQ-8) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Social Phobia Inventory (SPIN) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
Вторичные конечные точки (12)
- Personal Report of Communication Apprehension (PRCA-24) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Fidelity [Срок оценки: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)]
- Contamination [Срок оценки: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)]
- Study Burden [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Survey Completion [Срок оценки: between 10 and 0 days before the first intervention session, 48 hours after the final intervention session, and 1-month follow-up]
- Participant Retention [Срок оценки: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)]
- Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Self-Compassion Scale - Short (SCS) [Срок оценки: 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) [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Sense of Belonging Scale [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Likelihood to Recommend [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
- Enjoyableness [Срок оценки: 48 hours after the final intervention session and 1-month follow-up]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Renee Crown Wellness Institute and Department of Psychology & Neuroscience, University of — Boulder
Идентификаторы
NCT: NCT06673407 · 24-0178