Social AnxietyNCT03671577
Building Closer Friendships in Social Anxiety Disorder
A study testing Building Closer Friendships in people with Social Anxiety, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Building Closer Friendships
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently participating in therapy
- Current Substance Dependence
- Bipolar Disorder or psychotic illness
- Current suicidality (imminent risk)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32304
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Anxiety
- Being tested
- Building Closer Friendships
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Closer FriendshipsBehavioural
Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | four week computerized intervention designed to reduce fear of intimacy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in fear of intimacy from baseline to post treatment (4weeks) and one month follow up (8 weeks)
Secondary outcomes (5)
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.
Measured: Change in loneliness from baseline to post treatment (4weeks) and one month follow up (8 weeks)
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.
Measured: 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)
Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.
Measured: 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)
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.
Measured: Change in depression symptoms from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
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.
Measured: Change in suicide vulnerability from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start25 Oct 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into active treatment or waitlist control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671577
- Sponsor's protocol ID
- 2018.23774
- Other IDs
- 2018
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Closer Friendships in Social Anxiety Disorder: A Preliminary Test
- ClinicalTrials.gov ID
- NCT03671577
- Acronym / sponsor ID
- 2018.23774
- Conditions
- Social Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into active treatment or waitlist control.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Behavioral: Building Closer Friendshipsfour week computerized intervention designed to reduce fear of intimacy |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Currently participating in therapy
- Current Substance Dependence
- Bipolar Disorder or psychotic illness
- Current suicidality (imminent risk)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Building Closer FriendshipsIntervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships | Behavioural | Active Treatment |
Primary outcome
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.
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.
5 secondary outcomes
UCLA Loneliness Scale
Time frame: 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)
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)
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)
Interpersonal Needs Questionnaire (INQ)
Time frame: Change in suicide vulnerability from baseline to post treatment (4 weeks) and one month follow up (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Building Closer Friendships in people with Social Anxiety, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.