NCT03671577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

September 13, 2018

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (5)

  • UCLA Loneliness Scale

    Change in loneliness from baseline to post treatment (4weeks) and one month follow up (8 weeks)

  • Social Phobia inventory

    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)

    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)

    Change in depression symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)

  • Interpersonal Needs Questionnaire (INQ)

    Change in suicide vulnerability from baseline to post treatment (4 weeks) and one month follow up (8 weeks)

Study Arms (2)

Active Treatment

EXPERIMENTAL

four week computerized intervention designed to reduce fear of intimacy

Behavioral: Building Closer Friendships

Wait List Control

NO INTERVENTION

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

Interventions

Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships

Active Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently participating in therapy
  • Current Substance Dependence
  • Bipolar Disorder or psychotic illness
  • Current suicidality (imminent risk)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants will be randomized into active treatment or waitlist control, so they will be aware of the condition they are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into active treatment or waitlist control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 14, 2018

Study Start

October 25, 2018

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations