- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03671577
Building Closer Friendships in Social Anxiety Disorder
January 26, 2021 updated by: Jesse Cougle, Florida State University
Building Closer Friendships in Social Anxiety Disorder: A Preliminary Test
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32304
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Treatment
four week computerized intervention designed to reduce fear of intimacy
|
Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
|
|
No Intervention: Wait List Control
Participants will continue as usual and will be given the option to receive the active treatment after completion of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional Scale of Perceived Social Support
Time Frame: Change in Perceived Social Support from baseline to post treatment (4weeks) and one month follow up (8 weeks)
|
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)
|
|
Fear of Intimacy Scale-friend version
Time Frame: Change in fear of intimacy from baseline to post treatment (4weeks) and one month follow up (8 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
UCLA Loneliness Scale
Time Frame: Change in loneliness from baseline to post treatment (4weeks) and one month follow up (8 weeks)
|
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)
|
|
Social Phobia inventory
Time Frame: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
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)
|
|
State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
Time Frame: Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
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)
|
|
Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Change in depression symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
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)
|
|
Interpersonal Needs Questionnaire (INQ)
Time Frame: Change in suicide vulnerability from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2018
Primary Completion (Actual)
December 15, 2019
Study Completion (Actual)
December 15, 2019
Study Registration Dates
First Submitted
September 13, 2018
First Submitted That Met QC Criteria
September 13, 2018
First Posted (Actual)
September 14, 2018
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018.23774
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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