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Mobile CBT for Middle Aged and Older Adults

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Active, not recruiting

Conditions

Depressive Symptoms
Anxiety Disorders and Symptoms
Depression

Treatments

Behavioral: MAYA Mobile Application

Study type

Interventional

Funder types

Other

Identifiers

NCT05754151
23-01025548

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

MAYA Mobile App
Experimental group
Description:
Participants receive treatment with the MAYA application for 6 weeks
Treatment:
Behavioral: MAYA Mobile Application

Trial contacts and locations

1

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Central trial contact

Maddy Schier; Zareen Mir

Data sourced from clinicaltrials.gov

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