Clinical trial NCT06875726: Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care
Official title: Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression - Major Depressive Disorder
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm study of a micro-randomized digital intervention for teens with depression. All teens will receive the intervention, and randomization of which time points a teen receives an intervention or not will occur within-subject. The intervention will consist of messages sent via a secure app. Intervention messages will be possible up to 2x/day with a 50% chance of being delivered at each time point.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a tailored smartphone intervention called Sidekick can help improve sleep and physical activity for teenagers in depression treatment. The main question it aims to answer is:

Does Sidekick help teens improve sleep or physical activity?

Teen participants will be asked to complete surveys about how they are feeling and doing at the beginning of the study and throughout their participation. All teen participants will be able to use the Sidekick app during the study.


Eligibility criteria: Inclusion Criteria:

1. English-speaking
2. 13 to 17 years old
3. PHQ-8 score ≥5
4. PHQ-8 rating of ≥1 on anhedonia, sleep, or fatigue items
5. Own a personal smartphone

Exclusion Criteria:

1. Active safety concerns (e.g., acute suicidal ideation)
2. Diagnosed developmental disability (e.g., autism spectrum)
3. Primary mental health diagnosis other than MDD according to baseline Mini-international Neuropsychiatric Interview (MINI) (comorbidity allowed when MDD primary)
4. Sleep disorder from another medical cause
5. Inability to engage in moderate exercise because of medical concerns;

Primary outcomes:
measure: Sleep disturbance
timeFrame: Baseline to 4 weeks
measure: Sleep related impairment
timeFrame: Baseline to 4 weeks
measure: Sleep Quality
timeFrame: Baseline to 4 weeks
measure: Physical Activity Questionnaire - Adolescent
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Depression
timeFrame: Baseline to 4 weeks
measure: Anxiety
timeFrame: Baseline to 4 weeks
Other outcomes:
measure: Step Count
timeFrame: Baseline to 4 weeks
measure: Diagnostic Interview Schedule for Children
timeFrame: Baseline to 4 weeks
measure: Activity Intensity
timeFrame: Baseline to 4 weeks
measure: Suicide Ideation
timeFrame: Baseline to 4 weeks
measure: Functional Impairment
timeFrame: Baseline to 4 weeks
measure: Sleep Duration
timeFrame: Baseline to 4 weeks
measure: Midpoint sleep variability
timeFrame: Baseline to 4 weeks
Locations:
Study officials:
affiliation: University of Washington
name: Jessica Jenness, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: