Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

NCT04603053 | Completed

• 1 other identifier: 202005103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Depression; Anxiety Disorders

Keywords

Cognitive Behavioral Therapy; mHealth

Outcome Measures

Primary Outcomes (1)

• 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

  1 month

Secondary Outcomes (1)

• General Anxiety Disorder-7 (GAD-7)

  1 month

Study Arms (2)

CBot-A Group

EXPERIMENTAL

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

Behavioral: mHealth app

Wait List Group

NO INTERVENTION

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

Interventions

mHealth app BEHAVIORAL

Participants will receive access to CBot-A app for 12 weeks.

CBot-A Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Washington University Institute of Clinical and Translational Sciences: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Nicol G, Wang R, Graham S, Dodd S, Garbutt J. Chatbot-Delivered Cognitive Behavioral Therapy in Adolescents With Depression and Anxiety During the COVID-19 Pandemic: Feasibility and Acceptability Study. JMIR Form Res. 2022 Nov 22;6(11):e40242. doi: 10.2196/40242.

  PMID: 36413390 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jane Garbutt, MB, ChB

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Pediatrics

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 26, 2020
• Study Start: November 9, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

US (1)