Online Radical Acceptance Intervention for Social Anxiety Disorder (RA-SAD-001)

University of Haifa

Status: Not yet enrolling

Conditions: Social Anxiety Disorder (SAD)

Treatments: Behavioral: Relaxation Skills; Behavioral: Radical Acceptance

Study type: Interventional

Funder types: Other

Identifiers

NCT07325929

457-25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Radical Acceptance

Experimental group

Description:

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.

Treatment:

Behavioral: Radical Acceptance

Relaxation Skills

Active Comparator group

Description:

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.

Treatment:

Behavioral: Relaxation Skills