Waitlist-Control Trial of Smartphone (App-based) CBT for Social Anxiety Disorder (SAD)

Mass General Brigham

Status: Withdrawn

Conditions: Social Anxiety Disorder

Treatments: Device: Smartphone-delivered CBT for SAD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04622930

2018P001671

Details and patient eligibility

About

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).

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental: Smartphone-delivered CBT for SAD

Experimental group

Description:

12-week Smartphone delivered CBT for SAD.

Treatment:

Device: Smartphone-delivered CBT for SAD

12 Week Waitlist Control

Other group

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).

Treatment:

Device: Smartphone-delivered CBT for SAD