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Not yet recruiting NCT06875726

Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care

No phase Interventional Depression - Major Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sidekick.
Who it may be relevant to
Registry conditions: Depression - Major Depressive Disorder. Basic parameters: 13 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Sidekick
    Sidekick is a just-in-time adaptive intervention that sends behavior change messages based on personalized sleep and physical activity goals.

Primary outcome measures

  • Sleep disturbance [Time frame: Baseline to 4 weeks]
  • Sleep related impairment [Time frame: Baseline to 4 weeks]
  • Sleep Quality [Time frame: Baseline to 4 weeks]
  • Physical Activity Questionnaire - Adolescent [Time frame: Baseline to 4 weeks]
Secondary outcome measures (2)
  • Depression [Time frame: Baseline to 4 weeks]
  • Anxiety [Time frame: Baseline to 4 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06875726 · STUDY00019936 · R61MH132809

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗