Depression - Major Depressive Disorder
Conditions
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.
Interventions
BEHAVIORALSidekick
Sidekick is a just-in-time adaptive intervention that sends behavior change messages based on personalized sleep and physical activity goals.
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep disturbance | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline to 4 weeks | 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. |
| Anxiety | Baseline to 4 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Step Count | Baseline to 4 weeks | Step count will be collected via the Garmin smartwatch. The average daily step count over the 2-week baseline data collection period will be compared to the average daily step count in the last week of the intervention. |
| Midpoint sleep variability | Baseline to 4 weeks | The midpoint of sleep (clock time halfway between bedtime and waketime) will be collected via the Garmin smartwatch. The standard deviation of the midpoint during the two week baseline period will compared to the standard deviation of the midpoint during the last two weeks of the intervention period. |
| Diagnostic Interview Schedule for Children | Baseline to 4 weeks | — |
| Activity Intensity | Baseline to 4 weeks | Activity intensity will be collected via the Garmin smartwatch, categorized into light, medium, and vigorous. The average daily minutes of moderate + vigorous activity during the 2-week baseline data collection period will be compared to the average daily minutes of moderate + vigorous activity in the last week of the intervention. |
| Suicide Ideation | Baseline to 4 weeks | The Suicide Ideation Questionnaire-Junior (SIQ-Jr) measures the frequency of suicide ideations in the past month. The 15-item self-report assessment records frequency on a 7 point scale ranging from Almost every day (0) to I never had this thought (7). Scores range from 0 to 90 with higher scores indicating greater frequency of SI. |
| Functional Impairment | Baseline to 4 weeks | The Weiss Functional Impairment Rating Scale (WFIRS) is a self-report tool used to assess the functional impairment associated with ADHD symptoms across various domains, such as family, social, school/work, and emotional functioning. It includes 18 items rated on a 5-point scale. Total scores indicate the level of impairment, with higher scores reflecting greater functional difficulties and more significant impact on daily life. |
| Sleep Duration | Baseline to 4 weeks | Sleep duration will be collected via the Garmin smartwatch. The average daily sleep duration (in minutes) during the 2-week baseline data collection period will be compared to the average daily sleep duration (in minutes) in the last week of the intervention. |
Contacts
Primary ContactWarren Szewczyk
Outcome results
None listed