Loneliness Clinical Trial
Official title:
Computerized Intervention for Loneliness
Verified date | January 2021 |
Source | Florida State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.
Status | Completed |
Enrollment | 67 |
Est. completion date | April 30, 2020 |
Est. primary completion date | April 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Score of >48 on the UCLA Loneliness Scale Exclusion Criteria: - Concurrent psychotherapy for social anxiety or depression - Unstable psychotropic medication status (i.e. a change within the last month) - History of psychotic or (hypo)manic symptoms - Alcohol or other substance abuse or dependence within the last three months - Previous participation in a similar IBM study |
Country | Name | City | State |
---|---|---|---|
United States | Florida State University, Department of Psychology | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | UCLA Loneliness Scale (ULS) | 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 three month follow up (16 weeks) | |
Secondary | 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 three month follow up (16 weeks) | |
Secondary | 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. | Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks) | |
Secondary | 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. | Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks) | |
Secondary | 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. | Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks) | |
Secondary | 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. | Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks) | |
Secondary | Interpretations Questionnaire- Social Subscale (IQ-S) | Self report measure of interpretation bias of ambiguous social situations. Scales range from 0-44 with higher scores indicating a higher level of negative interpretation bias in social situations. | Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks) |
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