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| ID | Type | Description | Link |
|---|---|---|---|
| 5R33MH116089-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Mclean Hospital | OTHER |
| Tel Aviv University | OTHER |
| National Institute of Mental Health (NIMH) |
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The present study is a controlled trial that seeks to examine the feasibility, acceptability, mechanism, and efficacy of a recently developed computer-based therapy in individuals with social anxiety disorder (SAD)
This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two forms of a recently developed 4-week/8-session computer-based therapy in individuals with social anxiety disorder (SAD). The purpose of this study is to assess whether a brief computer-based research treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by what mechanism. The study will also assess the effect of research treatments on brain activity using magnetic resonance imaging (MRI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Computer-Based Treatment | Experimental | A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. |
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| Comparator Computer-Based Treatment | Active Comparator | A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer-Based Treatment | Behavioral | A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) | Clinician-rated scale scoring anxiety (0, none to 3, severe) and avoidance (0,none to 3, severe) in 24 social situations for a total score of 0 to 144. Higher scores indicate greater social anxiety. | From baseline up to Month 4 |
| Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire | Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80. | From baseline up to Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score of Social Phobia Inventory (SPIN) | The Social Phobia Inventory (SPIN) is a self-rated questionnaire used to assess severity of social anxiety disorder. 17 items related to social anxiety each rated on a score of 0 to 4, with a minimum total score of 0 (least social anxiety), and a maximum total score of 68 (most social anxiety). | Baseline to Month 4 |
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Inclusion Criteria:
Exclusion Criteria:
Present or past psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder, or bipolar disorder
Current severe depression
Suicidal ideation or behavior
Current diagnosis of post-traumatic stress disorder, obsessive-compulsive disorder, bipolar disorder, manic episode or tic disorder
Current or past organic mental disorder, seizure disorder, epilepsy or brain injury
Current unstable or untreated medical illness
Severe alcohol use disorder, severe cannabis use disorder, and any severity of other substance use disorder (except nicotine use disorders)
Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for at least 3 months
Any concurrent cognitive behavioral therapy or other psychotherapy that was initiated in the past 3 months
Pregnancy, or plans to become pregnant during the period of the study (will be assessed by urine)
Contraindication to MRI scanning (Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body)
Inability to tolerate MRI scanning procedures (i.e., severe obesity, claustrophobia)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franklin Schneier, MD | Contact | 6467748041 | franklin.schneier@nyspi.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| FRANKLIN SCHNEIER, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1051 Riverside Drive | Recruiting | New York | New York | 10032 | United States |
Data will be shared through the National Database for Clinical Trials related to Mental Illness (NDCT). We will obtain information needed to generate a Global Unique Identifier (GUID) for each participant (sex, first name, last name, middle name, date of birth, and city/municipality of birth). Raw data will be submitted semi-annually every January 15 and July 15, and prior to the end of each grant.
Beginning 12 months after completion of study assessments
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| NIH |
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| Clinical Global Impression-Change Scale | Clinical Global Impression-Change Scale: An observer rating of overall clinical change, with rating from 1 (very much improved) to 7 (very much worse). Responder category is defined by a score of 1 or 2. | Baseline to Month 4 |