Depression - Major Depressive DisorderNCT06875726
Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care
A study testing Sidekick in people with Depression - Major Depressive Disorder, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- Sidekick
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Sidekick
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SidekickBehavioural
Sidekick is a just-in-time adaptive intervention that sends behavior change messages based on personalized sleep and physical activity goals.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Behavioral: Sidekick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbance
The PROMIS Sleep Disturbance 8a scale for adolescents is a self-report assessment of sleep difficulties over the past week. It includes 8 items related to sleep quality and disturbances rated on a 5-point scale. Raw scores (range: 8 - 40) are converted to normalized T-scores, with higher scores indicating greater sleep disturbance
Measured: Baseline to 4 weeks
Sleep related impairment
The PROMIS Sleep-Related Impairment measure is a self-report assessment of the impact of sleep disturbances on daily functioning over the past week. It includes 8 items related to how sleep problems affect activities like school performance, mood, and social interactions, rated on a 5-point scale. Raw scores (range: 8-40) are converted to normalized T-scores, with higher scores indicating greater impairment in daily functioning due to sleep issues.
Measured: Baseline to 4 weeks
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a self-report assessment of sleep quality over the past month. It includes 19 items covering sleep patterns, duration, disturbances, and daytime dysfunction. Response values are combined into components produce a global score (range: 0-21), with higher scores indicating poorer sleep quality and greater sleep-related difficulties.
Measured: Baseline to 4 weeks
Physical Activity Questionnaire - Adolescent
The Physical Activity Questionnaire for Adolescents (PAQ-A) is a self-report assessment of physical activity levels in adolescents over the past 7 days. It includes 9 items related to the frequency and intensity of various physical activities, with responses on a 5-point scale. Scores are summed and averaged, with higher scores indicating greater physical activity levels.
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Depression
The Patient Health Questionnaire-9 (PHQ-9) is a self-report tool used to assess the severity of depressive symptoms over the past two weeks. It includes 9 items related to mood, interest, and other depressive symptoms, rated on a 4-point scale. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms and greater impairment.
Measured: Baseline to 4 weeks
Anxiety
The Generalized Anxiety Disorder-7 (GAD-7) is a self-report assessment of the severity of anxiety symptoms over the past two weeks. It includes 7 items related to anxiety-related feelings like worry, restlessness, and physical symptoms, rated on a 4-point scale. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms and greater impairment.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jessica Jenness, University of Washington
- Investigators
- Jessica Jenness, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875726
- Sponsor's protocol ID
- STUDY00019936
- Other IDs
- R61MH132809
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT06875726
- Acronym / sponsor ID
- STUDY00019936
- Conditions
- Depression - Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Behavioral: Sidekick |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SidekickSidekick is a just-in-time adaptive intervention that sends behavior change messages based on personalized sleep and physical activity goals. | Behavioural | Treatment arm |
Primary outcome
Sleep disturbance
Time frame: Baseline to 4 weeks
The PROMIS Sleep Disturbance 8a scale for adolescents is a self-report assessment of sleep difficulties over the past week. It includes 8 items related to sleep quality and disturbances rated on a 5-point scale. Raw scores (range: 8 - 40) are converted to normalized T-scores, with higher scores indicating greater sleep disturbance
Sleep related impairment
Time frame: Baseline to 4 weeks
The PROMIS Sleep-Related Impairment measure is a self-report assessment of the impact of sleep disturbances on daily functioning over the past week. It includes 8 items related to how sleep problems affect activities like school performance, mood, and social interactions, rated on a 5-point scale. Raw scores (range: 8-40) are converted to normalized T-scores, with higher scores indicating greater impairment in daily functioning due to sleep issues.
Sleep Quality
Time frame: Baseline to 4 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-report assessment of sleep quality over the past month. It includes 19 items covering sleep patterns, duration, disturbances, and daytime dysfunction. Response values are combined into components produce a global score (range: 0-21), with higher scores indicating poorer sleep quality and greater sleep-related difficulties.
Physical Activity Questionnaire - Adolescent
Time frame: Baseline to 4 weeks
The Physical Activity Questionnaire for Adolescents (PAQ-A) is a self-report assessment of physical activity levels in adolescents over the past 7 days. It includes 9 items related to the frequency and intensity of various physical activities, with responses on a 5-point scale. Scores are summed and averaged, with higher scores indicating greater physical activity levels.
2 secondary outcomes
Depression
Time frame: Baseline to 4 weeks
Anxiety
Time frame: Baseline to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Jenness, Ph.D. principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Sidekick in people with Depression - Major Depressive Disorder, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warren Szewczyk (2068801977, sidekick@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbance (time frame: Baseline to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.