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

Not Applicable

Not yet recruiting

• Conditions: Depression; Adolescent Behavior

• Registration Number: NCT06786247
• Lead Sponsor: University of Washington

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22
• Study Start: 2025-04
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention Usability Scale	Week 12	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.
User Burden Scale	Week 12	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.
Client Satisfaction Questionnaire - 8	Week 12	The CSQ-8 is an 8-item, unidimensional measure assessing general satisfaction with mental health services. Higher scores indicate greater satisfaction (range: 8 - 32)
Acceptability Of Intervention Measure	Week 12	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)
Intervention Appropriateness Measure	Week 12	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)
Feasibility Of Intervention Measure	Week 12	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)

Secondary Outcome Measures

Name	Time	Method
Loneliness	Baseline to Week 24	The self-report NIH Loneliness Toolbox assesses perceptions of loneliness in the past month using a 7-item survey for ages 8 to 17 scored on a 5-point Likert scale from 1 (Never) to 5 (Always). Higher total scores indicate greater loneliness. Age-adjusted scale scores will be generated for each participant.
Therapeutic Alliance	Week 12	The Working Alliance Inventory, Short Form (WAI-S) will be used to assess the therapeutic alliance between clients and therapists. The WAI-S comprises 12 items designed to evaluate the quality of the working relationship, agreement on goals, and agreement on tasks between the client and therapist. Each item is scored on a 1 to 7 Likert scale, where higher scores indicate stronger therapeutic alliance. The total score ranges from 12 to 84, with higher scores indicating a more positive and effective therapeutic alliance.