Computer-Based Treatment for Social Anxiety Disorder

Not Applicable

Completed

Conditions: Social Anxiety Disorder

Interventions: Behavioral: computer-based treatment

Registration Number: NCT03415022

Lead Sponsor: New York State Psychiatric Institute

Brief Summary: The present study is an open 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)

Detailed Description: This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two "doses" (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Males and females between the ages of 18 and 60
Current primary diagnosis of SAD
Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version)
Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol
Normal or corrected-to-normal vision

Exclusion Criteria

Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
Current severe depression
Suicidal ideation or behavior
Current diagnosis of posttraumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
Current unstable or untreated medical illness
Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders allowed)
Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months
Any concurrent cognitive behavioral therapy; other psychotherapy that was initiated in the past 3 months
Pregnancy, or plans to become pregnant during the period of the study - will be assessed by urine
Contraindication to MRI scanning:
Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)
Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4-week computer-based treatment	computer-based treatment	A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
8-week computer-based treatment	computer-based treatment	An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.

Primary Outcome Measures

Name	Time	Method
Change in Percent Dwell Time on Threat Faces	baseline to week 8	Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline.
Change in Total Score of Liebowitz Social Anxiety Scale (LSAS)	Baseline to week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change in Total Score of the Revised Social Anhedonia Scale	baseline to week 8	40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering "yes"(1), or "no"(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia)
Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire	baseline to week 8	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.
Clinical Global Impression-Change Scale	week 8	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.
Change in Total Score of the Snaith Hamilton Pleasure Scale	baseline to week 8	Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate as "strongly disagree" (1), "disagree" (2), "agree" (3), or "strongly agree" (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version	baseline to week 8	Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).
Change in Total Score of Social Phobia Inventory (SPIN)	baseline to week 8	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).