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Personalized Mobile Cognitive Behavioral Therapy Application

Primary Purpose

Anxiety Disorders and Symptoms, Depression, Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized MAYA Mobile App
General MAYA Mobile App
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age between 18 and 25 years. Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS). If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode. Exclusion Criteria: Lifetime diagnosis of a psychotic disorder. Current hypomanic or manic episode. 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 Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized

General Non-Personalized

Arm Description

Participants receive the personalized Maya app intervention for 6 weeks

Participants receive the general MAYA app intervention for 6 weeks

Outcomes

Primary Outcome Measures

Change in anxiety symptoms from pre-intervention to post-intervention 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 from pre-intervention to post-intervention as measured by HAM-D.
The primary symptom measure for depression will be the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.

Secondary Outcome Measures

Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A
Anxiety will be measured using 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 depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.
Depression will be scored using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Change in anhedonia from pre-intervention to post-intervention as measured by TEPS.
Anhedonia will be measured using the Temporal Experience of Pleasure Scale (TEPS). The items measure anticipatory and consummatory experiences of pleasure. Scores range from 18 to 108 where higher scores indicate stronger feelings of anticipating and experiencing pleasure.
Change in rumination from pre-intervention to post-intervention as measured by RRS.
Rumination will be measured using the Ruminative Response Scale (RRS). The items in this scale measure reflection and brooding. Scores on this scale range from 22 to 88, where higher scores indicate higher severity of symptoms of rumination
Change in Negative affect from pre-intervention to post-intervention as measured by PANAS
Negative affect will be measured using the negative affect subscale of the Positive and Negative Affect Schedule (PANAS). Scores on the 10-item subscale range from 10 to 50, where higher scores indicate higher levels of negative affect.
Anxious arousal from pre-intervention to post-intervention as measured by DASS.
Anxious arousal will be measured through the anxiety subscale of the Depression Anxiety Stress Scale (DASS). Scores on the anxiety subscale range from 0 to 42. Higher scores indicate higher severity of symptoms of anxious arousal.
Bipolar symptoms from pre-intervention to post-intervention as measured by ISS.
Bipolar symptoms will be measured using the Internal State Scale (ISS). The ISS is a 15 item self-report instrument using a visual analog line scale format (i.e. participant chooses from 0-100 on the scale to respond to each item). The scale contains four subscales (Activation, Well Being, Depression Index, and Perceived Conflict). Scores range from 0 to 1500 where higher scores represent higher severity of symptoms for each subscale.

Full Information

First Posted
January 17, 2023
Last Updated
August 22, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Children's Health Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05699525
Brief Title
Personalized Mobile Cognitive Behavioral Therapy Application
Official Title
Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Children's Health Fund

4. Oversight

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

5. Study Description

Brief Summary
This study aims to compare the effectiveness of a standard mobile iPhone cognitive behavioral therapy program to a personalized mobile iPhone cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional magnetic resonance imaging (MRI) and electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.
Detailed Description
Growing evidence suggests a need for anxiety and mood interventions that can be disseminated easily to adolescents and young adults. The goal of this study is to optimize a mobile application that teaches well-established, research-supported psychotherapeutic techniques to adolescents and young adults who are experiencing symptoms of anxiety, depression, and/or bipolar disorder. The study aims to compare the efficacy of a personalized mobile cognitive behavioral therapy program to a more general mobile cognitive behavioral therapy program. Study participants will randomly receive one of two versions of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults: either a standard version that includes a variety of skills typically used in CBT, or a personalized version with skills matched to the participant's symptom profile. In contrast to the general condition, which may introduce new material over all six weeks of the intervention, all new material in the personalized condition will be introduced within the first four weeks. The remaining two weeks in the personalized condition will consist of practicing previously learned skills. Participants will use the Maya app for two days per week, at least 20 minutes per day for six weeks and will complete assessments at baseline, week 4, week 6 (end of intervention), and a follow-up assessment at week 12. Participants may also choose to complete an optional magnetic resonance imaging (MRI) and/or electroencephalographic (EEG) recording at the baseline and end of intervention (week 6).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms, Depression, Bipolar Disorder, Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalized
Arm Type
Experimental
Arm Description
Participants receive the personalized Maya app intervention for 6 weeks
Arm Title
General Non-Personalized
Arm Type
Active Comparator
Arm Description
Participants receive the general MAYA app intervention for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Personalized MAYA Mobile App
Intervention Description
All new material in the personalized condition will be introduced within the first four weeks and will contain modules targeting participant's personal symptom profiles. The remaining two weeks in the personalized condition will consist of practicing previously learned skills.
Intervention Type
Behavioral
Intervention Name(s)
General MAYA Mobile App
Intervention Description
New material will be introduced to participants over all the six weeks of the intervention and will include all application modules.
Primary Outcome Measure Information:
Title
Change in anxiety symptoms from pre-intervention to post-intervention 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 to endpoint [Week 6]
Title
Change in depressive symptoms from pre-intervention to post-intervention as measured by HAM-D.
Description
The primary symptom measure for depression will be the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Time Frame
Baseline to endpoint [Week 6]
Secondary Outcome Measure Information:
Title
Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A
Description
Anxiety will be measured using 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 to end of active learning phase [week 4]
Title
Change in depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.
Description
Depression will be scored using the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Time Frame
Baseline to end of active learning phase [week 4]
Title
Change in anhedonia from pre-intervention to post-intervention as measured by TEPS.
Description
Anhedonia will be measured using the Temporal Experience of Pleasure Scale (TEPS). The items measure anticipatory and consummatory experiences of pleasure. Scores range from 18 to 108 where higher scores indicate stronger feelings of anticipating and experiencing pleasure.
Time Frame
Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Title
Change in rumination from pre-intervention to post-intervention as measured by RRS.
Description
Rumination will be measured using the Ruminative Response Scale (RRS). The items in this scale measure reflection and brooding. Scores on this scale range from 22 to 88, where higher scores indicate higher severity of symptoms of rumination
Time Frame
Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Title
Change in Negative affect from pre-intervention to post-intervention as measured by PANAS
Description
Negative affect will be measured using the negative affect subscale of the Positive and Negative Affect Schedule (PANAS). Scores on the 10-item subscale range from 10 to 50, where higher scores indicate higher levels of negative affect.
Time Frame
Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Title
Anxious arousal from pre-intervention to post-intervention as measured by DASS.
Description
Anxious arousal will be measured through the anxiety subscale of the Depression Anxiety Stress Scale (DASS). Scores on the anxiety subscale range from 0 to 42. Higher scores indicate higher severity of symptoms of anxious arousal.
Time Frame
Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]
Title
Bipolar symptoms from pre-intervention to post-intervention as measured by ISS.
Description
Bipolar symptoms will be measured using the Internal State Scale (ISS). The ISS is a 15 item self-report instrument using a visual analog line scale format (i.e. participant chooses from 0-100 on the scale to respond to each item). The scale contains four subscales (Activation, Well Being, Depression Index, and Perceived Conflict). Scores range from 0 to 1500 where higher scores represent higher severity of symptoms for each subscale.
Time Frame
Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 25 years. Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS). If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode. Exclusion Criteria: Lifetime diagnosis of a psychotic disorder. Current hypomanic or manic episode. 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 Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
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

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