Clinical trial NCT06673407: Group Exposure Workshops for Socially Anxious Undergraduates
Official title: Pilot Trial on the Contribution of Peer Leaders and Self-Compassion to Group Exposure Workshops for Socially Anxious Undergraduates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Public Speaking Fear
Public Speaking Anxiety
Social Fear
Keywords: Social Anxiety
Public Speaking Anxiety
Exposure Therapy
Peer-led
Self-compassion
Common Humanity
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This trial uses a 2-variable full factorial design within the Multiphase Optimization Strategy (MOST) framework. Participants will be assigned to one of four study conditions involving 5.5-7.5-hours of workshops (depending on study condition) conducted over 3 in-person group sessions. Study conditions will vary depending on whether they 1) include self-compassion (i.e., common humanity) enhancements, and 2) are led by peer co-facilitators.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Attendance rate
timeFrame: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)
measure: Enrollment rate
timeFrame: Pre-intervention (from screening to enrollment)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Social Phobia Inventory (SPIN)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
Secondary outcomes:
measure: Personal Report of Communication Apprehension (PRCA-24)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Fidelity
timeFrame: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)
measure: Contamination
timeFrame: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)
measure: Study Burden
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Survey Completion
timeFrame: between 10 and 0 days before the first intervention session, 48 hours after the final intervention session, and 1-month follow-up
measure: Participant Retention
timeFrame: 3 weeks during the intervention (workshops 1, 2, and 3, 1 week apart)
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Self-Compassion Scale - Short (SCS)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Stigma and Self-Stigma Scale, help seeking behaviors and self-stigma subscales (SASS)
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Sense of Belonging Scale
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Likelihood to Recommend
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Enjoyableness
timeFrame: 48 hours after the final intervention session and 1-month follow-up
measure: Provider preference
timeFrame: between 0 and 10 days before the first intervention session, 48 hours after the final intervention session, and 1-month follow-up
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Renee Crown Wellness Institute and Department of Psychology & Neuroscience, University of Colorado Boulder
state: Colorado
Study officials:
References: