Clinical trial NCT05754151: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Depressive Symptoms
Depression
Keywords: Anxiety
CBT
Mobile Application
Cognitive Behavioral Therapy
Depression
Older Adults
Adults
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Joseph S. Sanchez Foundation
First posted: 2023-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Acceptability of the MAYA application as measured by mean uMARS scores at Baseline
timeFrame: Week 1 (Baseline)
measure: Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint
timeFrame: Week 3 (Midpoint)
measure: Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint
timeFrame: Week 6 (Endpoint)
measure: Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint
timeFrame: Week 6 (Endpoint)
measure: Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up
timeFrame: Week 12 (Follow Up)
Secondary outcomes:
measure: Change in anxiety symptoms as measured by the HAM-A
timeFrame: Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)
measure: Change in depressive symptoms as measured by the MADRS
timeFrame: Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jennifer Bress, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: