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

NCT ID: NCT04622930

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-01

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).

Conditions

Social Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Smartphone-delivered CBT for SAD

12-week Smartphone delivered CBT for SAD.

Group Type: EXPERIMENTAL

Smartphone-delivered CBT for SAD

Intervention Type: DEVICE

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.

12 Week Waitlist Control

12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for SAD following the 12-week waitlist control).

Group Type: OTHER

Smartphone-delivered CBT for SAD

Intervention Type: DEVICE

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.

Interventions

Smartphone-delivered CBT for SAD

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koa Health B.V.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabine Wilhelm, PhD

Chief of Phycology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Wilhelm, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2018P001671

Identifier Type: -

Identifier Source: org_study_id

NCT03769363

Identifier Type: -

Identifier Source: nct_alias