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

NCT ID: NCT06875726

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

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.

Conditions

Depression - Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Group Type: EXPERIMENTAL

Sidekick

Intervention Type: BEHAVIORAL

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

Interventions

Sidekick

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

Intervention Type: BEHAVIORAL

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;

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jessica Jenness

Assistant Professor: Department of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Jenness, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Warren Szewczyk

Role: CONTACT

sidekick@uw.edu

2068801977

Other Identifiers

R61MH132809

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00019936

Identifier Type: -

Identifier Source: org_study_id