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

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ClinicalTrials.gov Identifier: NCT03769363
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Telefónica S.A.
Information provided by (Responsible Party):
Sabine Wilhelm, PhD, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Social Anxiety Disorder Device: Smartphone-delivered CBT for SAD Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smartphone Cognitive Behavioral Therapy for Social Anxiety Disorder: A Randomized, Waitlist-control Trial
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Smartphone-delivered CBT for SAD
12-week Smartphone delivered CBT for SAD.
Device: 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.

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).
Device: 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.




Primary Outcome Measures :
  1. Difference in SAD severity (LSAS) at the end of treatment/waitlist period. [ Time Frame: Endpoint (week 12) ]
    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 :
  1. Difference in depression at the end of treatment/waitlist period [ Time Frame: Endpoint (week 12) ]
    Participants who receive app-CBT will have greater improvement on depression (QIDS-SR). The QIDS-SR is a self-report measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Higher scores correspond with greater depression severity, and the measure is a well-validated, sensitive measure of symptom severity in depression.

  2. Difference in functional impairment at the end of treatment/waitlist period [ Time Frame: Endpoint (week 12) ]
    Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.

  3. Difference in quality of life at the end of treatment/waitlist period [ Time Frame: Endpoint (week 12) ]
    Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769363


Contacts
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Contact: Anna Schwartzberg, BA 617-724-7161 ASCHWARTZBERG@mgh.harvard.edu
Contact: Hilary Weingarden, PhD 6176436206 Hilary_Weingarden@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Telefónica S.A.
Investigators
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Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital

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Responsible Party: Sabine Wilhelm, PhD, Chief of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03769363     History of Changes
Other Study ID Numbers: 2018P001671
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders