Clinical trial NCT06786247: Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents
Official title: Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Adolescent Behavior
Keywords: depression
adolescence
asynchronous remote community
behavioral activation
digital health
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Intervention Usability Scale
timeFrame: Week 12
measure: User Burden Scale
timeFrame: Week 12
measure: Client Satisfaction Questionnaire - 8
timeFrame: Week 12
measure: Acceptability Of Intervention Measure
timeFrame: Week 12
measure: Intervention Appropriateness Measure
timeFrame: Week 12
measure: Feasibility Of Intervention Measure
timeFrame: Week 12
Secondary outcomes:
measure: Loneliness
timeFrame: Baseline to Week 24
measure: Therapeutic Alliance
timeFrame: Week 12
Other outcomes:
measure: Enrollment Rate
timeFrame: Baseline
measure: Loss to Follow Up Rate
timeFrame: Baseline to Week 24
measure: Behavioral Activation Attendance
timeFrame: Baseline to Week 12
measure: Behavioral Activation Homework Completion
timeFrame: Baseline to Week 12
measure: Behavioral Activation Skill Use
timeFrame: Baseline to Week 12
measure: ActivaTeen - Time Spent on Platform
timeFrame: Baseline to Week 12
measure: ActivaTeen - Messaging Rates
timeFrame: Baseline to Week 12
measure: Treatment-Related Adverse Events
timeFrame: Baseline to Week 24
measure: Suicidality
timeFrame: Baseline to Week 24
measure: Depression Symptoms
timeFrame: Baseline to Week 24
measure: Anxiety Symptoms
timeFrame: Baseline to Week 24
measure: Major Depressive Disorder
timeFrame: Baseline to Week 24
measure: Externalizing psychopathology symptoms
timeFrame: Baseline to Week 24
measure: Client-Centeredness of Treatment
timeFrame: Week 12
Locations:
Study officials:
affiliation: University of Washington
name: Jessica Jenness, PhD
role: PRINCIPAL_INVESTIGATOR
References: