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Building Closer Friendships in Social Anxiety Disorder

Primary Purpose

Social Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Building Closer Friendships
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Treatment

Wait List Control

Arm Description

four week computerized intervention designed to reduce fear of intimacy

Participants will continue as usual and will be given the option to receive the active treatment after completion of the study

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 13, 2018
Last Updated
January 26, 2021
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03671577
Brief Title
Building Closer Friendships in Social Anxiety Disorder
Official Title
Building Closer Friendships in Social Anxiety Disorder: A Preliminary Test
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into active treatment or waitlist control.
Masking
Outcomes Assessor
Masking Description
Participants will be randomized into active treatment or waitlist control, so they will be aware of the condition they are in.
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Treatment
Arm Type
Experimental
Arm Description
four week computerized intervention designed to reduce fear of intimacy
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participants will continue as usual and will be given the option to receive the active treatment after completion of the study
Intervention Type
Behavioral
Intervention Name(s)
Building Closer Friendships
Intervention Description
Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
Primary Outcome Measure Information:
Title
Multidimensional Scale of Perceived Social Support
Description
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.
Time Frame
Change in Perceived Social Support from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Title
Fear of Intimacy Scale-friend version
Description
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.
Time Frame
Change in fear of intimacy from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Secondary Outcome Measure Information:
Title
UCLA Loneliness Scale
Description
A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
Time Frame
Change in loneliness from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Title
Social Phobia inventory
Description
Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
Time Frame
Change in social anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Title
State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
Description
Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.
Time Frame
Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Title
Center for Epidemiological Studies Depression Scale (CES-D)
Description
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.
Time Frame
Change in depression symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Title
Interpersonal Needs Questionnaire (INQ)
Description
Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide.
Time Frame
Change in suicide vulnerability from baseline to post treatment (4 weeks) and one month follow up (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32304
Country
United States

12. IPD Sharing Statement

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Building Closer Friendships in Social Anxiety Disorder

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