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

Overview

This study aims to assess a mobile 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). Participants can complete optional recordings of electrical brain activity (electroencephalography, or EEG) at baseline and week 6.

Interventions

• Behavioral MAYA Mobile Application
  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

Primary outcome measures

• Acceptability of the MAYA application as measured by mean uMARS scores at Baseline [Time frame: Week 1 (Baseline)]
• Acceptability of the MAYA application as measured by mean uMARS scores at Midpoint [Time frame: Week 3 (Midpoint)]
• Acceptability of the MAYA application as measured by mean uMARS scores at Endpoint [Time frame: Week 6 (Endpoint)]
• Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Endpoint [Time frame: Week 6 (Endpoint)]
• Feasibility of the MAYA application as measured by total number of sessions completed in the MAYA application at Follow Up [Time frame: Week 12 (Follow Up)]

Secondary outcome measures (2)

• Change in anxiety symptoms as measured by the HAM-A [Time frame: Baseline, Week 6 (Endpoint), and Week 12 (Follow Up)]
• Change in depressive symptoms as measured by the MADRS [Time frame: Baseline, Week 6 (Endpoint), 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, iPad, or Android device.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Weill Cornell Medicine — New York

Identifiers

NCT: NCT05754151 · 23-01025548

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗