Computer - Based Treatment for Social Anxiety Disorder
ConditionSocial Anxiety Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNew York State Psychiatric Institute
About this trial
The present study is a controlled trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females between the ages of 18 to 60
Current primary diagnosis of SAD
Score of at least 50 on the Liebowitz Social Anxiety Scale (self-rated version)
Fluent in English
Disqualifiers
Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
Current severe depression
Suicidal ideation or behavior
Current diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Computer-Based Treatment
BehavioralA 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Experimental Computer-Based TreatmentExperimental treatment 1 intervention
Group B: Comparator Computer-Based TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)
Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety.
Time frame
From baseline up to Month 42
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire
Quality of Life Enjoyment \& Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.
Time frame
From baseline up to Month 4Secondary outcomes
1
Change in Total Score of Social Phobia Inventory (SPIN)
The Social Phobia Inventory (SPIN) is a self-rated questionnaire used to assess severity of social anxiety disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety).
Time frame
Baseline to Month 42
Clinical Global Impression-Change Scale
Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2.
Time frame
Baseline to Month 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
New York State Psychiatric Institute
Lead sponsor
Columbia University
Collaborator
Mclean Hospital
Collaborator
Tel Aviv University
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
University of Texas
Collaborator
Source ClinicalTrials.gov