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Building Closer Friendships in Social Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03671577
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Jesse Cougle, Florida State University

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.

Condition or disease Intervention/treatment Phase
Social Anxiety Behavioral: Building Closer Friendships Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized into active treatment or waitlist control.
Masking: Single (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.
Primary Purpose: Treatment
Official Title: Building Closer Friendships in Social Anxiety Disorder: A Preliminary Test
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active Treatment
four week computerized intervention designed to reduce fear of intimacy
Behavioral: Building Closer Friendships
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671577


Locations
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United States, Florida
Florida State University
Tallahassee, Florida, United States, 32304
Sponsors and Collaborators
Florida State University
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Responsible Party: Jesse Cougle, Associate Professor, Florida State University
ClinicalTrials.gov Identifier: NCT03671577    
Other Study ID Numbers: 2018.23774
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders