Social Anxiety Disorder (SAD)
Conditions
Keywords
social anxiety disorder, acceptance, emotion regulation, guided self-help, digital intervention
Brief summary
The goal of this clinical trial is to learn if a self-guided online Radical Acceptance program helps reduce symptoms of Social Anxiety Disorder. The study will also compare this program to an online relaxation skills program. The main questions are: * Does the Radical Acceptance program lower symptoms of Social Anxiety Disorder? * Is the Radical Acceptance program more helpful than relaxation skills? Adults with Social Anxiety Disorder will be randomly assigned to one of two online programs. They will complete a baseline learning session and six short home practice sessions over two weeks. Participants will answer surveys about their symptoms and complete brief computer tasks. Researchers will measure changes in social anxiety at several points during the study and again a few weeks and a few months later.
Detailed description
This randomized controlled trial will evaluate a self-guided online Radical Acceptance intervention for adults with Social Anxiety Disorder. The intervention is adapted from Dialectical Behavior Therapy (DBT) and is designed to help individuals notice and accept difficult thoughts and feelings that arise during social situations. The study will compare this program with an active control condition that provides training in relaxation skills, also adapted from DBT, which focus on physiological strategies for reducing acute emotional arousal. The study will enroll 100 adults diagnosed with Social Anxiety Disorder. All study activities take place online. After eligibility is confirmed through structured diagnostic interviews, participants will complete a baseline learning session followed by six home practice sessions delivered over a two-week period. Participants in both conditions will receive culturally adapted video-based training followed by a brief debriefing to ensure understanding and correct application of the assigned skill. The trial is designed to examine changes in social anxiety symptoms over time and to compare the effects of Radical Acceptance and relaxation skills training. In addition to symptom outcomes, the study will assess several proposed mechanisms of change. These mechanisms include interpretation bias and emotion regulation flexibility measured through behavioral tasks, as well as experiential avoidance, rumination, and difficulties in emotion regulation measured through self-report instruments. Mechanism assessments will be completed at baseline and after the fourth practice session. Participants will also report their momentary positive and negative emotions before and after each practice session. Recruitment will occur through online advertisements. Screening includes an online questionnaire followed by a telephone interview and a video-based diagnostic assessment using the ADIS-5 and selected DIAMOND modules, administered by trained graduate students. Eligible individuals will provide informed consent for both the assessment session and the intervention phase of the study. Participants will be randomly assigned by an automated algorithm to one of the two study conditions. All assessments and intervention procedures will be completed remotely. The study includes follow-up assessments at three weeks and three months after the intervention to evaluate the stability of treatment effects.
Interventions
BEHAVIORALRadical Acceptance
Online DBT-based program focusing on implementing radical acceptance in daily life and coping with socially anxious situations.
BEHAVIORALRelaxation Skills
Online DBT-based program teaching relaxation techniques to achieve rapid physiological down-regulation and improve emotional control.
Sponsors
University of Haifa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a two-arm parallel randomized controlled trial in which participants are assigned to either a self-guided online Radical Acceptance intervention or an active relaxation skills training control condition. All participants complete the same assessment schedule, and each individual receives only the intervention assigned at random.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-45 * Score \> 9 on Mini-SPIN * Positive responses in brief phone screening * Eligibility confirmed in Zoom interview using ADIS * Native Hebrew speakers * Having regular access to a computer.
Exclusion criteria
* Changes in psychiatric medication in the past 3 months * Current or past diagnosis of bipolar disorder * Current or past diagnosis of schizophrenia * Current or past diagnosis of PTSD * Current or past diagnosis of substance use disorder * History of traumatic brain injury (TBI) * Previous experience with Dialectical Behavior Therapy (DBT) * Currently receiving psychotherapy specifically targeting social anxiety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liebowitz Social Anxiety Scale | baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up | Change in social anxiety symptoms using the self-report Liebowitz Social Anxiety Scale (LSAS). In this questionnaire, participants are asked to respond to 24 social situations by marking how much they feel fear in each situation (anxiety subscale) and to which extent they will avoid this situation (avoidance subscale) on a 0-3 Likert scale. This measure ranges 0-144; higher scores indicate greater social anxiety severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder-7 | baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up | Change in social anxiety symptoms using the self-report Generalized Anxiety Disorder-7 (GAD-7). Participants rate how frequently they have been bothered by each symptom over the past two weeks using a 4-point Likert scale (0-3). This questionnaire ranges 0-21; higher scores indicate greater anxiety severity. |
| Patient Health Questionnaire-9 | Time Frame: baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up | Change in depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Respondents report how often they have experienced each symptom over the past two weeks using a 4-point Likert scale (0-3). This questionnaire ranges 0-27; higher scores indicate greater depressive symptom severity. |
Countries
Israel
Contacts
CONTACTNoam Weinbach, PhD
PRINCIPAL_INVESTIGATORNoam Weinbach, PhD
School of Psychological Sciences, University of Haifa
Outcome results
None listed