Online Radical Acceptance Intervention for Social Anxiety Disorder
ConditionSocial Anxiety Disorder (SAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity of Haifa
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-45
Score > 9 on Mini-SPIN
Positive responses in brief phone screening
Eligibility confirmed in Zoom interview using ADIS
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Radical Acceptance
BehavioralOnline DBT-based program focusing on implementing radical acceptance in daily life and coping with socially anxious situations.
Relaxation Skills
BehavioralOnline DBT-based program teaching relaxation techniques to achieve rapid physiological down-regulation and improve emotional control.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Radical AcceptanceExperimental treatment 1 intervention
Group B: Relaxation SkillsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Liebowitz Social Anxiety Scale
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.
Time frame
baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-upSecondary outcomes
1
Generalized Anxiety Disorder-7
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.
Time frame
baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-up2
Patient Health Questionnaire-9
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
Time Frame: baseline, after session 4 (~1 week), 2 weeks (end of treatment), 3-week follow-up, 3-month follow-upOther outcomes
1
Word-sentence association task
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.
Time frame
baseline, after session 4 (~1 week)2
Emotional faces task
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).
Time frame
baseline, after session 4 (~1 week)3
Emotion regulation flexibility task
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.
Time frame
baseline, after session 4 (~1 week)4
Brief Experiential Avoidance Questionnaire
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.
Time frame
baseline, after session 4 (~1 week)Sponsors and contacts
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Source ClinicalTrials.gov