Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT

NCT ID: NCT04603053

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2021-08-20

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.

Conditions

Adolescent Depression; Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBot-A Group

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

Group Type: EXPERIMENTAL

mHealth app

Intervention Type: BEHAVIORAL

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

Wait List Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mHealth app

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University Institute of Clinical and Translational Sciences

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jane Garbutt, MD

Professor of Medicine and Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane Garbutt, MB, ChB

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36413390 (View on PubMed)

Other Identifiers

202005103

Identifier Type: -

Identifier Source: org_study_id