Back to resultsWaitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD)
Primary Purpose
Social Anxiety Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone-delivered CBT for SAD
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Current diagnosis of primary DSM-5 SAD, based on MINI
- Currently living in the United States
Exclusion Criteria:
- Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- Past participation in ≥ 4 sessions of CBT for SAD
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 ***EDIT***
- Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
- Concurrent psychological treatment
- Does not own a supported mobile Smartphone with a data plan
- Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental: Smartphone-delivered CBT for SAD
12 Week Waitlist Control
Arm Description
12-week Smartphone delivered CBT for SAD.
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for SAD following the 12-week waitlist control).
Outcomes
Primary Outcome Measures
Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered measure of social anxiety symptom severity. It contains 24 social situations likely to elicit social anxiety, and items are scored on a Likert scale ranging from 0 to 3. Higher scores indicate more severe SAD symptoms. The LSAS will be used to assess change in social anxiety symptoms from baseline to endpoint.
Secondary Outcome Measures
Difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12.
Participants who receive app-CBT will have a difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12. The CESD-R is a self-report measure of depressive symptoms consisting of 20 scale items with responses ranging from 0 to 4, including two questions about suicidal ideation (item #14, #15). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12.
Participants who receive app-CBT will have a difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12. The WSAS uses a Likert scale from 0 (not at all impaired) to 8 (very severely impaired) to assess impairment in occupational, social, and family/friends domains. Higher scores indicate greater impairment.
Difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12.
Participants who receive app-CBT will have a difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12. The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Full Information
NCT ID
NCT04622930
First Posted
October 13, 2020
Last Updated
May 15, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04622930
Brief Title
Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD)
Official Title
Smartphone Cognitive Behavioral Therapy for Social Anxiety Disorder: A Randomized, Waitlist-control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No longer proceeding with this study.
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).
Detailed Description
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with SAD recruited nationally. Eligible subjects (N=80) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for SAD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for SAD will be feasible and acceptable to individuals with SAD, and that it will lead to greater reductions in SAD symptom severity compared to the passage of time (waitlist control).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Smartphone-delivered CBT for SAD
Arm Type
Experimental
Arm Description
12-week Smartphone delivered CBT for SAD.
Arm Title
12 Week Waitlist Control
Arm Type
Other
Arm Description
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for SAD following the 12-week waitlist control).
Intervention Type
Device
Intervention Name(s)
Smartphone-delivered CBT for SAD
Intervention Description
12-week Smartphone-delivered CBT for SAD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for SAD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
Primary Outcome Measure Information:
Title
Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
Description
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered measure of social anxiety symptom severity. It contains 24 social situations likely to elicit social anxiety, and items are scored on a Likert scale ranging from 0 to 3. Higher scores indicate more severe SAD symptoms. The LSAS will be used to assess change in social anxiety symptoms from baseline to endpoint.
Time Frame
Endpoint (week 12)
Secondary Outcome Measure Information:
Title
Difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12.
Description
Participants who receive app-CBT will have a difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12. The CESD-R is a self-report measure of depressive symptoms consisting of 20 scale items with responses ranging from 0 to 4, including two questions about suicidal ideation (item #14, #15). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.
Time Frame
Endpoint (week 12)
Title
Difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12.
Description
Participants who receive app-CBT will have a difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12. The WSAS uses a Likert scale from 0 (not at all impaired) to 8 (very severely impaired) to assess impairment in occupational, social, and family/friends domains. Higher scores indicate greater impairment.
Time Frame
Endpoint (week 12)
Title
Difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12.
Description
Participants who receive app-CBT will have a difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12. The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
Time Frame
Endpoint (week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Current diagnosis of primary DSM-5 SAD, based on MINI
Currently living in the United States
Exclusion Criteria:
Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
Past participation in ≥ 4 sessions of CBT for SAD
Current severe substance use disorder
Lifetime bipolar disorder or psychosis
Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 ***EDIT***
Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
Concurrent psychological treatment
Does not own a supported mobile Smartphone with a data plan
Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Waitlist-Control Trial of Smartphone CBT for Social Anxiety Disorder (SAD)
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