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

NCT06786247 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY000188875R34MH128387-02
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Keywords

depression; adolescence; asynchronous remote community; behavioral activation; digital health

Outcome Measures

Primary Outcomes (6)

• Intervention Usability Scale

  The IUS was adapted from the System Usability Scale, with the word "system" replaced with "intervention platform" for each item. Items are rated on a Likert-type scale from 0 (strongly disagree) to 4 (strongly agree) and half of the items are reverse-scored. The total score is calculated by multiplying the sum of these scores by 2.5 (possible range: 0-100), with higher scores indicating greater usability.

  Week 12

• User Burden Scale

  The User Burden Scale (UBS) is a widely used and reliable scale that includes 20-items that capture user burden of computing systems across 6 subscales1) difficulty of use, 2) physical, 3) time and social, 4) mental and emotional, 5) privacy, and 6) financial. Items are rated on a 5-point Likert scale from 0 (Never/Not at all) to 4 (All of the time/Extremely). Higher scale scores indicate greater user burden.

  Week 12

• Client Satisfaction Questionnaire - 8

  The CSQ-8 is an 8-item, unidimensional measure assessing general satisfaction with mental health services. Higher scores indicate greater satisfaction (range: 8 - 32)

  Week 12

• Acceptability Of Intervention Measure

  The Acceptability of Intervention Measure assesses the acceptability of a particular intervention. The measure has 4 items each and responses are coded on a 1 - 5 Likert scale (Completely Disagree to Completely Agree). Higher scores indicate greater acceptability (range: 4 - 20)

  Week 12

• Intervention Appropriateness Measure

  The Intervention Appropriateness Measure assesses the appropriateness of a particular intervention. The measure has 4 items each and responses are coded on a 1 - 5 Likert scale (Completely Disagree to Completely Agree). Higher scores indicate greater appropriateness (range: 4 - 20)

  Week 12

• Feasibility Of Intervention Measure

  The Feasibility of Intervention Measure assesses the feasibility of a particular intervention. The measure has 4 items each and responses are coded on a 1 - 5 Likert scale (Completely Disagree to Completely Agree). Higher scores indicate greater feasibility (range: 4 - 20)

  Week 12

Secondary Outcomes (2)

• Loneliness

  Baseline to Week 24

• Therapeutic Alliance

  Week 12

Other Outcomes (14)

• Enrollment Rate

  Baseline

• Loss to Follow Up Rate

  Baseline to Week 24

• Behavioral Activation Attendance

  Baseline to Week 12

Study Arms (2)

ActivaTeen + BA

EXPERIMENTAL

Receives access to ActivaTeen app along with individual behavioral activation therapy

Behavioral: ActivaTeen; Behavioral: Behavioral Activation

BA Only

ACTIVE COMPARATOR

Receives individual behavioral activation therapy alone

Behavioral: Behavioral Activation

Interventions

ActivaTeen 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.

ActivaTeen + BA

Behavioral Activation 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.

Also known as: BA

ActivaTeen + BA; BA Only

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depression; Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessica Jenness, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Warren Szewczyk

CONTACT

206-543-5080; activateen@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 22, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01