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Mobile CBT for Middle Aged and Older Adults

Primary Purpose

Anxiety Disorders and Symptoms, Depressive Symptoms, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAYA Mobile Application
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorders and Symptoms focused on measuring Anxiety, CBT, Mobile Application, Cognitive Behavioral Therapy, Depression, Older Adults, Adults

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 40 or older Primary diagnosis of an anxiety or depressive disorder as determined by a clinical severity rating score of 4 or greater on the Anxiety Disorders Interview Schedule (ADIS). Mini Mental Status Exam (MMSE) no more than 1 SD below the mean score for patient's age and education. If the remote version of the MMSE is used (e.g. during an evaluation on Zoom), the remote MMSE score will be converted to a standard MMSE score. Access to an Apple iPhone Exclusion Criteria: Lifetime diagnosis of a bipolar or psychotic disorder. Currently in cognitive behavior therapy. Change in dose of a psychiatric medication in the past 12 weeks. Initiation of psychotherapy in the past 12 weeks. Intent or plan to attempt suicide.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MAYA Mobile App

Arm Description

Participants receive treatment with the MAYA application for 6 weeks

Outcomes

Primary Outcome Measures

Acceptability of the MAYA application as measured by mean uMARS scores at Baseline
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint
Total number of sessions completed by the end of the administered intervention
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up
Total number of sessions completed by the end of the administered intervention

Secondary Outcome Measures

Change in anxiety symptoms as measured by the HAM-A
The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Change in depressive symptoms as measured by the MADRS
Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item questionnaire measuring the severity of depression symptoms. Scores range from 0 to 60, where higher scores indicate higher severity of depressive symptoms.

Full Information

First Posted
February 22, 2023
Last Updated
August 8, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05754151
Brief Title
Mobile CBT for Middle Aged and Older Adults
Official Title
Feasibility and Acceptability of a Mobile Cognitive Behavior Therapy App Targeting Depression and Anxiety in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess a mobile iPhone app called MAYA for use in middle-aged and older adults with anxiety or mood disorders. The MAYA app is designed to teach coping skills for anxiety and depression that are drawn from cognitive behavioral therapy. Participants will be asked to use the app for at least two days a week, 20 minutes on each day, for six weeks. Participants will have weekly check-ins as well as longer assessments at the beginning of the study, week 3, week 6 (end of treatment), and week 12 (follow up). During assessments, participants will answer brief questionnaires designed to assess their symptoms and impressions of the app. The main hypotheses of the study are that participants will complete most of the assigned sessions and that they will rate their impressions of the app highly. The secondary hypotheses are that symptoms of depression and anxiety will decrease with use of the MAYA app.
Detailed Description
There is a growing need for accessible, affordable, research-supported treatments designed for older adults. Older adults face challenges that limit their ability to physically access mental health services; thus, mobile app-based interventions may be particularly appealing to individuals in this age range with anxiety or depression who are unable to access more traditional psychotherapy administered in person by a therapist. Mobile technology has been used previously to deliver mental health services for adults with a variety of psychiatric symptoms (Dennis & O'Toole, 2014). Anxiety frequently co-occurs with depression, with 72% of individuals with anxiety having experienced a history of depression (Moffitt et al., 2007). Current models conceptualize anxiety and depression as a confluence of three broad symptom categories - physiological hyperarousal, low positive affect, and high negative affect (Clark & Watson, 1991) - that are present to different degrees in different individuals. This study aims to assess the acceptability, feasibility and efficacy of "MAYA", a mobile cognitive behavioral therapy app for anxiety and mood disorders, in middle aged and older adults. This study will collect pilot data over the course of 12 weeks. As this is a pilot study, all participants will use the same version of the app and there will be no control group. Participants will be asked to use the mobile app for at least two days a week, for at least 20 minutes on each day, for 6 weeks. Participants will have weekly check-ins in person or via a HIPAA-compliant virtual meeting platform (e.g., Zoom) to assess intervention adherence and answer brief questionnaires designed to assess feasibility, acceptability, and mood symptoms at baseline, week 3, week 6 (end of treatment), and week 12 (follow up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms, Depressive Symptoms, Depression
Keywords
Anxiety, CBT, Mobile Application, Cognitive Behavioral Therapy, Depression, Older Adults, Adults

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All participants will receive the same intervention. Therefore, no masking is required.
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MAYA Mobile App
Arm Type
Experimental
Arm Description
Participants receive treatment with the MAYA application for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
MAYA Mobile Application
Intervention Description
The mobile cognitive behavioral therapy (CBT) application, MAYA, teaches cognitive behavioral therapy (CBT) techniques including emotion monitoring, cognitive restructuring, mindfulness, exposure and psychoeducation (i.e. information about anxiety and depression). The application includes an interactive dashboard to provide the user with statistics for tracking progress toward their goals. Although the MAYA application is new, its content and structure are similar to how CBT- a well-established and widely used psychosocial intervention - is commonly delivered in the more traditional setting of a psychotherapist's office.
Primary Outcome Measure Information:
Title
Acceptability of the MAYA application as measured by mean uMARS scores at Baseline
Description
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Time Frame
Week 1 (Baseline)
Title
Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint
Description
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Time Frame
Week 3 (Midpoint)
Title
Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
Description
The primary measure to assess accessibility of the MAYA app will be the User Version of the Mobile Application Rating Scale (uMARS). The uMARS is a 26-item questionnaire that evaluates the quality of the mobile health applications with six subscales: engagement, functionality, aesthetics, information, app subjective quality, perceived impact. Scores on the scale can range from 21 to 130, where higher scores represent higher quality of mobile health applications by end-users.
Time Frame
Week 6 (Endpoint)
Title
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint
Description
Total number of sessions completed by the end of the administered intervention
Time Frame
Week 6 (Endpoint)
Title
Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up
Description
Total number of sessions completed by the end of the administered intervention
Time Frame
Week 12 (Follow Up)
Secondary Outcome Measure Information:
Title
Change in anxiety symptoms as measured by the HAM-A
Description
The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Time Frame
Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)
Title
Change in depressive symptoms as measured by the MADRS
Description
Depression will be measured using the Montgomery-Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item questionnaire measuring the severity of depression symptoms. Scores range from 0 to 60, where higher scores indicate higher severity of depressive symptoms.
Time Frame
Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 or older Primary diagnosis of an anxiety or depressive disorder as determined by a clinical severity rating score of 4 or greater on the Anxiety Disorders Interview Schedule (ADIS). Mini Mental Status Exam (MMSE) no more than 1 SD below the mean score for patient's age and education. If the remote version of the MMSE is used (e.g. during an evaluation on Zoom), the remote MMSE score will be converted to a standard MMSE score. Access to an Apple iPhone Exclusion Criteria: Lifetime diagnosis of a bipolar or psychotic disorder. Currently in cognitive behavior therapy. Change in dose of a psychiatric medication in the past 12 weeks. Initiation of psychotherapy in the past 12 weeks. Intent or plan to attempt suicide.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maddy Schier
Phone
(646) 289-5271
Ext
720
Email
mas4019@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Zareen Mir
Phone
(646)-289-5271
Ext
705
Email
zam4005@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Bress, Ph.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Bress, Ph.D
Phone
914-997-8683
Email
jeb2061@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Maddy Schier
Phone
(646) 289-5271
Ext
720
Email
mas4019@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Bress, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mobile CBT for Middle Aged and Older Adults

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