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Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

Primary Purpose

Adolescent Depression, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth app
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Depression focused on measuring Cognitive Behavioral Therapy, mHealth

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.

Exclusion Criteria:

Adolescents with the following conditions (identified by parental report) will be excluded:

  • Participated in formal CBT within the past 12-months
  • Diagnosed with severe depression
  • Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
  • A psychiatric hospitalization in the previous month
  • With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness.
  • Are not accompanied by a guardian to the diagnostic visit
  • Without access to a mobile device (cell phone or tablet) for regular use
  • Unable to read and write English
  • Participants may also be excluded at the discretion of the PI.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBot-A Group

Wait List Group

Arm Description

Participants randomly assigned to this arm will receive access to CBot-A app.

Participants randomly assigned to this arm will be offered the intervention after the completion of the trial.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms

Secondary Outcome Measures

General Anxiety Disorder-7 (GAD-7)
This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms

Full Information

First Posted
October 16, 2020
Last Updated
July 18, 2022
Sponsor
Washington University School of Medicine
Collaborators
Washington University Institute of Clinical and Translational Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04603053
Brief Title
Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT
Official Title
Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
August 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
Washington University Institute of Clinical and Translational Sciences

4. Oversight

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

5. Study Description

Brief Summary
Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.
Detailed Description
In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents. The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Depression, Anxiety Disorders
Keywords
Cognitive Behavioral Therapy, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBot-A Group
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will receive access to CBot-A app.
Arm Title
Wait List Group
Arm Type
No Intervention
Arm Description
Participants randomly assigned to this arm will be offered the intervention after the completion of the trial.
Intervention Type
Behavioral
Intervention Name(s)
mHealth app
Intervention Description
Participants will receive access to CBot-A app for 12 weeks.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
The PHQ-9 Adolescent Version will be used.This 9-item instrument scores from 0 to 27, with higher scores indicating more depressive symptoms
Time Frame
1 month
Secondary Outcome Measure Information:
Title
General Anxiety Disorder-7 (GAD-7)
Description
This 7 item instrument scores from 0 to 21 with higher scores indicating more anxiety symptoms
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months. Exclusion Criteria: Adolescents with the following conditions (identified by parental report) will be excluded: Participated in formal CBT within the past 12-months Diagnosed with severe depression Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias A psychiatric hospitalization in the previous month With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness. Are not accompanied by a guardian to the diagnostic visit Without access to a mobile device (cell phone or tablet) for regular use Unable to read and write English Participants may also be excluded at the discretion of the PI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Garbutt, MB, ChB
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

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