Social Anxiety Disorder
Conditions
Keywords
SAD, Social Anxiety, Social Phobia
Brief summary
The present study is an open 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)
Detailed description
This randomized clinical trial examines the feasibility, acceptability, mechanism, and relative efficacy of two doses (standard 4-week/8 session vs. extended 8-week/12-session) of a recently developed 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).
Interventions
BEHAVIORALcomputer-based treatment
30 minute sessions of free viewing of faces and listening to music
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will not be informed as to whether a participant is randomized to 4 or 8 weeks of treatment.
Intervention model description
Computer-based task involving free viewing of faces and listening to music
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males and females between the ages of 18 and 60 * Current primary diagnosis of SAD * Score of at least 50 on the Liebowitz Social Anxiety Scale (Self-rated version) * Fluent in English and willing and able to give informed written consent and participate responsibly in the protocol * Normal or corrected-to-normal vision
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 posttraumatic 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 allowed) * Use of psychiatric medication in the past month other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) for a least 3 months * Any concurrent cognitive behavioral therapy; 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 (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos) * Being unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Dwell Time on Threat Faces | baseline to week 8 | Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline. |
| Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) | Baseline to week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Score of the Revised Social Anhedonia Scale | baseline to week 8 | 40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering yes(1), or no(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia) |
| Change in Total Score of the Snaith Hamilton Pleasure Scale | baseline to week 8 | Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate as strongly disagree (1), disagree (2), agree (3), or strongly agree (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia) |
| Change in Total Score of Social Phobia Inventory (SPIN) | baseline to week 8 | 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). |
| Clinical Global Impression-Change Scale | week 8 | 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. |
| Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version | baseline to week 8 | Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression). |
| Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire | baseline to week 8 | 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. |
Countries
United States
Participant flow
Pre-assignment details
9 participants discontinued the study after initial evaluation but before treatment randomization: * 5 discontinued due to scheduling difficulties * 2 discontinued due to COVID-19 research suspension * 2 discontinued due to difficulties calibrating eye tracker used for treatment sessions
Participants by arm
| Arm | Count |
|---|---|
| 4-week Computer-based Treatment A 4-week (8-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks.
computer-based treatment: 30 minute sessions of free viewing of faces and listening to music | 21 |
| 8-week Computer-based Treatment An 8-week (12-sessions) course of computer-based treatment. Participants will receive treatment twice a week for four weeks, and then once a week for the subsequent four weeks.
computer-based treatment: 30 minute sessions of free viewing of faces and listening to music | 20 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 Suspension | 2 | 3 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | 4-week Computer-based Treatment | 8-week Computer-based Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 20 Participants | 41 Participants |
| Age, Continuous | 27.7 years STANDARD_DEVIATION 5.08 | 29.15 years STANDARD_DEVIATION 7.13 | 28.61 years STANDARD_DEVIATION 6.19 |
| Liebowitz Social Anxiety Scale | 83.8 units on a scale STANDARD_DEVIATION 16.81 | 87.6 units on a scale STANDARD_DEVIATION 11.32 | 86.05 units on a scale STANDARD_DEVIATION 14.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 6 Participants | 16 Participants |
| Region of Enrollment United States | 21 participants | 20 participants | 41 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 0 / 21 | 0 / 20 |
| serious Total, serious adverse events | 0 / 21 | 0 / 20 |
Outcome results
Primary
Change in Percent Dwell Time on Threat Faces
Percent dwell time on threat faces was computed as the ratio of gaze dwell time on threat faces to total dwell time on all faces as measured by eye tracking during treatment sessions. Change in percent dwell time is the value at week 8 minus value at baseline.
Time frame: baseline to week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Percent Dwell Time on Threat Faces | 20.7 percentage of dwell time on threat faces | Standard Deviation 20.6 |
| 8-week Computer-based Treatment | Change in Percent Dwell Time on Threat Faces | 27.1 percentage of dwell time on threat faces | Standard Deviation 17.6 |
Primary
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.
Time frame: Baseline to week 8
Population: Participants who completed 8 weeks of study participation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) | 23.68 score on a scale | Standard Deviation 32.44 |
| 8-week Computer-based Treatment | Change in Total Score of Liebowitz Social Anxiety Scale (LSAS) | 22.38 score on a scale | Standard Deviation 22.87 |
Secondary
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.
Time frame: baseline to week 8
Population: participants who completed 8 weeks of assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire | -8.8 score on a scale | Standard Deviation 15.3 |
| 8-week Computer-based Treatment | Change in Total Score of Quality of Life Enjoyment & Satisfaction Questionnaire | -4.8 score on a scale | Standard Deviation 12.4 |
Secondary
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).
Time frame: baseline to week 8
Population: participants with 8 weeks of assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Total Score of Social Phobia Inventory (SPIN) | 17.7 score on a scale | Standard Deviation 18.5 |
| 8-week Computer-based Treatment | Change in Total Score of Social Phobia Inventory (SPIN) | 10.1 score on a scale | Standard Deviation 13.5 |
Secondary
Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version
Hamilton Rating Scale for Depression -17 item version. This standard scale will be used to assess severity of depression, minimum score is 0 (least depression); maximum score is 50 (greatest depression).
Time frame: baseline to week 8
Population: participants who completed 8 weeks of assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version | 1.8 units on a scale | Standard Deviation 4.4 |
| 8-week Computer-based Treatment | Change in Total Score of the Hamilton Rating Scale for Depression - 17 Item Version | 1.8 units on a scale | Standard Deviation 5.8 |
Secondary
Change in Total Score of the Revised Social Anhedonia Scale
40-item self-rated social anhedonia scale. Items are comprised of statements that participants agree or disagree with, by answering yes(1), or no(0), with some items reverse-coded. The minimum score is 0 (least social anhedonia); maximum score is 40 (most social anhedonia)
Time frame: baseline to week 8
Population: participants who completed 8 weeks of assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Total Score of the Revised Social Anhedonia Scale | 1.7 units on a scale | Standard Deviation 5.6 |
| 8-week Computer-based Treatment | Change in Total Score of the Revised Social Anhedonia Scale | 1.8 units on a scale | Standard Deviation 4.9 |
Secondary
Change in Total Score of the Snaith Hamilton Pleasure Scale
Snaith Hamilton Pleasure Scale (SHAPS). Fourteen-item self-rated anhedonia scale. Items are comprised of statements that participants rate as strongly disagree (1), disagree (2), agree (3), or strongly agree (4). The lowest possible score was 14, the highest possible score was 56 (greatest anhedonia)
Time frame: baseline to week 8
Population: participants who completed 8 weeks of assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Change in Total Score of the Snaith Hamilton Pleasure Scale | 2.2 units on a scale | Standard Deviation 6.2 |
| 8-week Computer-based Treatment | Change in Total Score of the Snaith Hamilton Pleasure Scale | -1.0 units on a scale | Standard Deviation 5.8 |
Secondary
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.
Time frame: week 8
Population: participants who completed 8 weeks of assessments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4-week Computer-based Treatment | Clinical Global Impression-Change Scale | 2.8 units on a scale | Standard Deviation 1.2 |
| 8-week Computer-based Treatment | Clinical Global Impression-Change Scale | 2.7 units on a scale | Standard Deviation 0.9 |