Clinical trial NCT03101553: Computerized Treatment for Social Anxiety
Official title: Computerized Treatment for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.


Eligibility criteria: Inclusion Criteria:

* Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria
* SPIN score greater than or equal to 30
* Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))

Exclusion Criteria:

* Concurrent psychotherapy or treatment for social anxiety disorder
* Clinically significant suicidality
* Current Alcohol Use Disorder of "Severe" severity or higher
* Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher
* Recent changes (less than four weeks) in psychiatric medication
* History of psychotic symptoms
* May not have participated in a similar computerized treatment program

Primary outcomes:
measure: Social Phobia Inventory (SPIN; Davidson, 1995)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
Secondary outcomes:
measure: Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
measure: Beck Anxiety Inventory (BAI; Steer & Beck, 1997)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
measure: Interpretations Questionnaire-modified (IQ-modified; Buhlmann et al., 2002)
timeFrame: change from baseline at one-week post treatment and 3-months post-treatment
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Department of Psychology
state: Florida
Study officials:
References: