Mobile Cognitive Behavior Therapy Targeting Anxiety Disorders

NCT05130281 | Completed Results DMC

• 1 other identifier: 1803019086
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to examine different ways of motivating people to make use of Maya, a mobile cognitive behavior therapy (CBT) program for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. Subjects will use the Maya app for at least 20 minutes per day, 2 days per week, for 6 weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and an optional magnetic resonance imaging (MRI) recording.

Conditions

Anxiety Disorders and Symptoms

Keywords

anxiety; mental health; adolescents; young adults; CBT; mobile app; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (3)

• Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)

  Change in anxiety between the three incentive conditions will be measured using the Hamilton Rating Scale for Anxiety (HAM-A), a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety, where higher scores, defined by a score range of 18-56, indicate a greater presence of symptoms and lower scores, defined by a score range of 0-17, indicate mild to no anxiety symptoms.

  Baseline to week 6 (end of intervention)

• Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)

  Change in anxiety between the three incentive conditions will be measured using the Anxiety Sensitivity Index (ASI). The ASI is an 18-item scale containing three subscales measuring physical, cognitive, and social concerns regarding anxiety. Higher scores, defined by a score range of 18-72, reflect greater self-reported concern and lower scores, defined by a score range of 0-17, reflect little self-reported concern.

  Baseline to week 6 (end of intervention)

• Change in Anxious Symptoms From Baseline to End of Treatment (Week 6)

  Change in anxiety between the three incentive conditions will be measured using the the Leibowitz Social Anxiety Scale (LSAS). The LSAS is a 24-item scale measuring fear and avoidance across social situations with a total score range of 0-144. Higher scores, defined by a total score range of 50-95 or greater, indicate greater fear and avoidance severity and lower scores, defined by a total score range of 0-49, indicate mild to no fear or avoidance.

  Baseline to week 6 (end of intervention)

Secondary Outcomes (2)

• Mean Number of Sessions Completed

  End of intervention (week 6)

• Mean Rating Score on the Mobile Application Rating Scale

  End of intervention (week 6)

Study Arms (3)

Social Support

EXPERIMENTAL

Participants receive treatment with the Maya app in conjunction with social support incentives for 6 weeks.

Behavioral: Maya mobile app; Behavioral: Social Support

Gain Framed

EXPERIMENTAL

Participants receive treatment with the Maya app in conjunction with gain-framed incentives for 6 weeks.

Behavioral: Maya mobile app; Behavioral: Gain Framed

Loss Framed

EXPERIMENTAL

Participants receive treatment with the Maya app in conjunction with loss-framed incentives for 6 weeks.

Behavioral: Maya mobile app; Behavioral: Loss Framed

Interventions

Maya mobile app BEHAVIORAL

The Maya app teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, and exposure to help individuals with anxiety.

Gain Framed; Loss Framed; Social Support

Social Support BEHAVIORAL

Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message. Participants can identify a person they know to receive updates about their progress and support them throughout their time in the program. Participants will not be required to choose a person they know to receive updates about their use of the program; instead, they can choose to have a member of the study team serve as their social support if they are assigned to this condition.

Social Support

Gain Framed BEHAVIORAL

Participants earn points and badges for completing sessions, homework, and skills on time and receive post session feedback via text message.

Gain Framed

Loss Framed BEHAVIORAL

Participants lost points and badges for not completing sessions, homework, and skills on time and receive post session feedback via text message.

Loss Framed

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 25
• Primary diagnosis of an anxiety disorder, as determined by a score of 4 on the Clinical Severity Rating from the Anxiety Disorders Interview Schedule (ADIS)

You may not qualify if:

• Score of \< 4 on the ADIS
• Primary psychiatric diagnosis other than an anxiety disorder
• Currently in cognitive behavioral therapy outside of the study
• Change in dose of a psychiatric medication in the past 12 weeks
• Intent or plan to attempt suicide

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (1)

• Bress JN, Falk A, Schier MM, Jaywant A, Moroney E, Dargis M, Bennett SM, Scult MA, Volpp KG, Asch DA, Balachandran M, Perlis RH, Lee FS, Gunning FM. Efficacy of a Mobile App-Based Intervention for Young Adults With Anxiety Disorders: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428372. doi: 10.1001/jamanetworkopen.2024.28372.

  PMID: 39163044 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Maddy Schier
• Organization: Weill Cornell Medicine

mas4019@med.cornell.edu

(646) 289-5271

Study Officials

• Faith Gunning, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial designed to assess the feasibility of Maya, an app-based CBT intervention, and provide preliminary efficacy data for three different incentive strategies. Participants will be randomized to one of three incentive conditions: 1) a social support condition, 2) a gain-framed condition in which participants can earn "points" for completing assigned therapy sessions, and 3) a loss-framed condition in which participants begin with a specified number of points that they can lose for failing to complete assigned therapy sessions on time.

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: November 23, 2021
• Study Start: June 18, 2021
• Primary Completion: November 3, 2022
• Study Completion: December 8, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)