Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents

NCT ID: NCT06786247

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-03-01

Brief Summary

The goal of this clinical trial is to learn if a digital health intervention, called "ActivaTeen," improves depression treatment for teenagers with depression. The investigators also want to know if ActivaTeen is easy to use for both teenagers and mental health clinicians who help deliver treatment through ActivaTeen. All teenagers in the study will receive an individual depression therapy called Behavioral Activation or "BA" and about half will also use ActivaTeen.

The main questions this trial aims to answer are:

• Does ActivaTeen improve depression treatment for teenagers?
• Do teenagers and clinicians find ActivaTeen to be acceptable?

Researchers will compare teenagers using ActivaTeen along with BA to teenagers who are only doing BA to see the effects of ActivaTeen.

Participants in the study will:

• Fill out surveys online several times during the study, which lasts about 6 months
• Receive individual BA therapy

Conditions

Depression; Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ActivaTeen + BA

Receives access to ActivaTeen app along with individual behavioral activation therapy

Group Type: EXPERIMENTAL

ActivaTeen

Intervention Type: BEHAVIORAL

The ActivaTeen app is built on HIPAA-compliant instance of a popular messaging software. Participants in the treatment group can access the app at any time via desktop or mobile, where they can find features designed to enhance their receipt of BA therapy.

These features include: weekly BA skills and homework completion support, in-app messaging with their BA therapist, mood and activity tracking and data visualizations, chatbot check-ins on progress and guided problem-solving around barriers, and moderated peer support using the ActivaTeen app. The app will have a moderator, who is part of the study team, to manage peer-to-peer interactions within ActivaTeen.

Behavioral Activation

Intervention Type: BEHAVIORAL

Behavioral activation therapy involves individual weekly sessions with a trained therapist for 12 weeks. The sessions are completed either in-person or via telehealth. The treatment focuses on behavioral manifestations of depression such as isolating, and how these behaviors are interconnected with low mood and depressive emotions. BA helps patients find ways to engage in behaviors that are meaningful to them based on their values, priorities, and goals, with the aim of creating positive loops between doing meaningful activities and improved mood. The therapist provides structure and problem-solving for activating these behaviors and keeping track of changes over time.

BA Only

Receives individual behavioral activation therapy alone

Group Type: ACTIVE_COMPARATOR

Behavioral Activation

Intervention Type: BEHAVIORAL

Behavioral activation therapy involves individual weekly sessions with a trained therapist for 12 weeks. The sessions are completed either in-person or via telehealth. The treatment focuses on behavioral manifestations of depression such as isolating, and how these behaviors are interconnected with low mood and depressive emotions. BA helps patients find ways to engage in behaviors that are meaningful to them based on their values, priorities, and goals, with the aim of creating positive loops between doing meaningful activities and improved mood. The therapist provides structure and problem-solving for activating these behaviors and keeping track of changes over time.

Interventions

ActivaTeen

The ActivaTeen app is built on HIPAA-compliant instance of a popular messaging software. Participants in the treatment group can access the app at any time via desktop or mobile, where they can find features designed to enhance their receipt of BA therapy.

These features include: weekly BA skills and homework completion support, in-app messaging with their BA therapist, mood and activity tracking and data visualizations, chatbot check-ins on progress and guided problem-solving around barriers, and moderated peer support using the ActivaTeen app. The app will have a moderator, who is part of the study team, to manage peer-to-peer interactions within ActivaTeen.

Intervention Type: BEHAVIORAL

Behavioral Activation

Behavioral activation therapy involves individual weekly sessions with a trained therapist for 12 weeks. The sessions are completed either in-person or via telehealth. The treatment focuses on behavioral manifestations of depression such as isolating, and how these behaviors are interconnected with low mood and depressive emotions. BA helps patients find ways to engage in behaviors that are meaningful to them based on their values, priorities, and goals, with the aim of creating positive loops between doing meaningful activities and improved mood. The therapist provides structure and problem-solving for activating these behaviors and keeping track of changes over time.

Intervention Type: BEHAVIORAL

Other Intervention Names

BA

Eligibility Criteria

Inclusion Criteria

• Age 13 - 19
• Referred for MDD treatment
• Clinically assessed diagnosis of current MDD based on caregiver or patient report or a PHQ-8 total of 8 or greater (moderate MDD)
• MDD clinically determined to be the primary diagnosis
• English-speaking
• Access to a smartphone device

Exclusion Criteria

• Developmental disability (e.g., intellectual disability, autism spectrum disorder)
• Severe psychiatric comorbidity (e.g., active suicidality requiring higher level of care; psychosis or substance use, bipolar, or conduct disorder)
• Previously completed a full course of evidence based psychosocial intervention for depression

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jessica Jenness

Associate Professor: Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Jenness, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Warren Szewczyk

Role: CONTACT

activateen@uw.edu

206-543-5080

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R34MH128387-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00018887

Identifier Type: -

Identifier Source: org_study_id