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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03671577
Other study ID # 2018.23774
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2018
Est. completion date December 15, 2019

Study information

Verified date January 2021
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses whether a 4-week computerized intervention can be used to decrease fear of intimacy, and loneliness and improve perceived social support in people with Social Anxiety Disorder.


Description:

This study hopes to assess whether a month long computerized intervention aimed at giving people skills to form closer friendships. Participants will be randomized into an active treatment condition or a wait list control. We hypothesize that 1) participants in the treatment condition will have lower fear of intimacy at post treatment than those in the waitlist condition 2) participants in the treatment condition will have lower levels of loneliness than those in the waitlist condition 3) participants in the treatment condition will have higher perceived social support than those in the waitlist condition.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Social Anxiety Disorder Diagnosed by the Mini International Neuropsychiatric Interview - Social Phobia Inventory Score >19 - Stable psychotropic medication for the past month and kept stable for duration of study Exclusion Criteria: - Currently participating in therapy - Current Substance Dependence - Bipolar Disorder or psychotic illness - Current suicidality (imminent risk)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Building Closer Friendships
Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships

Locations

Country Name City State
United States Florida State University Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Multidimensional Scale of Perceived Social Support Self-report scale that measures perceived levels of social support. Scores range from 12 to 84 with higher scores indicating higher levels of perceived social support. The three subscales (friends, family and significant other) all have a range of 4 to 28 with higher scores indicating higher levels of perceived social support. Change in Perceived Social Support from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Primary Fear of Intimacy Scale-friend version self report scale measuring fear of intimacy in friendships. Scores range from 26 to 130 with higher scores indicating a higher level of fear of intimacy. Change in fear of intimacy from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Secondary UCLA Loneliness Scale A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness. Change in loneliness from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Secondary Social Phobia inventory Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms. Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T) Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety. Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary Center for Epidemiological Studies Depression Scale (CES-D) Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms. Change in depression symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Secondary Interpersonal Needs Questionnaire (INQ) Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide. Change in suicide vulnerability from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
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