Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05754151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-02-22
Brief Title:
Mobile CBT for Middle Aged and Older Adults
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Feasibility and Acceptability of a Mobile Cognitive Behavior Therapy App Targeting Depression and Anxiety in Older Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 OToole 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None