- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325929
Online Radical Acceptance Intervention for Social Anxiety Disorder (RA-SAD-001)
Online Radical Acceptance Intervention for Social Anxiety Disorder: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noam Weinbach, PhD
- Phone Number: +972542249161
- Email: nweinbach@psy.haifa.ac.il
Study Locations
-
-
-
Haifa, Israel, 3498838
- Recruiting
- University of Haifa
-
Contact:
- Noam Beker
- Phone Number: 0542249161
- Email: nweinbach@psy.haifa.ac.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Radical Acceptance
Participants will receive an online radical acceptance training based on DBT principles.
The intervention consists of six guided exercises delivered over a two-week period, designed to enhance acceptance of distressing internal experiences.
|
Online DBT-based program focusing on implementing radical acceptance in daily life and coping with socially anxious situations.
|
|
Active Comparator: Relaxation Skills
Participants will receive an online training in DBT TIPP relaxation skills (Temperature, Intense Exercise, Paced Breathing/Progressive Muscle Relaxation).
The intervention includes six guided exercises over two weeks, aiming to rapidly decrease physiological arousal and support emotion regulation under stress.
|
Online DBT-based program teaching relaxation techniques to achieve rapid physiological down-regulation and improve emotional control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liebowitz Social Anxiety Scale
Time Frame: 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.
|
baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder-7
Time Frame: 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.
|
baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up
|
|
Patient Health Questionnaire-9
Time Frame: 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.
|
Time Frame: baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Word-sentence association task
Time Frame: baseline, after session 4 (~1 week)
|
Change in interpretation bias will be evaluated using a word-sentence association task (WSAP).
The dependent variable is the proportion of trials in which participants selected the negative interpretation, with higher proportions indicating a stronger negative interpretation bias.
|
baseline, after session 4 (~1 week)
|
|
Emotional faces task
Time Frame: baseline, after session 4 (~1 week)
|
Change in interpretation bias using a computerized task with facial emotion stimuli.
In this task, two dependent measures were derived: the proportion of trials in which participants accurately identified the intended emotional expression for each emotion category (e.g., correctly labeling a happy face as positive).
|
baseline, after session 4 (~1 week)
|
|
Emotion regulation flexibility task
Time Frame: baseline, after session 4 (~1 week)
|
Change in emotion regulation flexibility as measured by a computerized experimental task.
The dependent variables will include the number of trials in which participants chose to use cognitive reappraisal, and the average level of negative affect reported following trials in which reappraisal was selected, serving as an index of implementation success.
|
baseline, after session 4 (~1 week)
|
|
Brief Experiential Avoidance Questionnaire
Time Frame: baseline, after session 4 (~1 week)
|
Change in experiential avoidance as measured by the Brief Experiential Avoidance Questionnaire (BEAQ).
Items are rated on a 6-point Likert scale (1-6).
scores range 15-90; with higher scores indicate greater experiential avoidance.
|
baseline, after session 4 (~1 week)
|
|
Ruminative Responses Scale
Time Frame: baseline, after session 4 (~1 week)
|
Change in rumination as measured by the Ruminative Responses Scale (RRS).Participants rate each statement on a 4-point Likert scale ranging from 1 ("almost never") to 4 ("almost always"), indicating how frequently they respond to feelings of sadness or low mood in the described manner.
The RRS yields a total rumination score as well as three subscales representing distinct aspects of ruminative thought: (1) Brooding, (2) Reflection, and (3) Depressive rumination.
Higher scores indicate greater rumination.
|
baseline, after session 4 (~1 week)
|
|
Positive and Negative Affect Schedule
Time Frame: Before and after each of the six practice sessions: ~day 2, 4, 6, 8, 10, 12
|
Change in positive and negative emotions by selected items from the Positive and Negative Affect Schedule (PANAS).
We selected the 12 most relevant items from the pool for our study, assessing basic negative and positive emotion scales such as fear, sadness, hostility, joviality, self-assurance and attentiveness.
Each item will be scored on a 4-point Likert-scale ranging from 1-5.
Higher ratings indicate stronger emotional reactions.
|
Before and after each of the six practice sessions: ~day 2, 4, 6, 8, 10, 12
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Noam Weinbach, PhD, School of Psychological Sciences, University of Haifa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 457-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Social Anxiety Disorder (SAD)
-
Newleos Therapeutics, Inc.Recruiting
-
Vanda PharmaceuticalsRecruitingSocial Anxiety Disorder (SAD)United States
-
Stockholm UniversityActive, not recruiting
-
Second Affiliated Hospital, School of Medicine,...RecruitingSocial Anxiety Disorder (SAD)China
-
Engrail Therapeutics INCCompletedSocial Anxiety Disorder (SAD)United States
-
Hong Kong Shue Yan UniversityNot yet recruitingSocial Phobia | Social Anxiety Disorder (SAD)
-
Ono Pharmaceutical Co. LtdActive, not recruiting
-
Sumitomo Pharma America, Inc.BehaVR LLCCompletedSocial Anxiety Disorder (SAD)United States
-
Emory UniversityBristol-Myers SquibbCompleted
-
Sykehuset Innlandet HFUniversity of Oslo; Yale University; University of Bergen; Norwegian University... and other collaboratorsRecruitingSocial Anxiety Disorder (SAD)Norway
Clinical Trials on Radical Acceptance
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingThoracic Surgery | Cardiac Disease | Blood Transfusion; HemoglobinemiaSpain
-
Anne Roche, MACompletedQuality of Life | AgingUnited States
-
Federal University of Espirito SantoEnrolling by invitationUpper Limb Amputation at the HandBrazil
-
University of Electronic Science and Technology...RecruitingEmotion Regulation | Nonsuicidal Self InjuryChina
-
Newcastle UniversityUniversity of Bristol; University of Liverpool; University of AberdeenUnknownAcceptance, SocialUnited Kingdom
-
Philipps University Marburg Medical CenterCompletedPsychological Stress | Physiological StressGermany
-
University of HaifaRambam Health Care CampusRecruitingChronic Pain | Somatic Pain | Comorbid Pain and Emotional DifficultiesIsrael
-
National and Kapodistrian University of AthensUnknownColorectal Neoplasms | Pain, Procedural | Acceptance ProcessGreece
-
Universidade Federal do ParanáActive, not recruitingObsessive-Compulsive DisorderBrazil
-
Nazarbayev UniversityNot yet recruitingCervical Cancer Screening