Clinical trial NCT06626425: Well-being Training for Adolescent Depressive Symptoms (TeenWell Study)
Official title: Smartphone-based Meditation Training to Reduce Adolescent Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: adolescent
meditation
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized active-controlled wait-list trial
Primary purpose: TREATMENT

Brief summary: This study is being done to see if the Healthy Minds Program app helps adolescents with elevated depressive symptoms. Up to 200 participants will be on study for 20 weeks.

Detailed description: Participants will be randomized into one of two groups: Healthy Minds Program intervention group (HMP) or a water tracking active control group. The groups will use different mobile health apps for eight weeks. All participants will complete assessments pre-intervention, after weeks 2, 4, and 6 of the intervention, at week 8 (post-intervention), and at week 20 (follow-up). Participants will complete a short daily diary set of questions on their social interactions that day. Participants will wear a Biostrap band for continuous collection of heart rate, movement, and daily sleep indices, and geolocation data will be extracted from participant phones using the FollowMee app. Participants will receive access to the app they were not assigned to after follow-up.

Primary Objective

* Assess acceptability and preliminary efficacy of an 8-week mHealth meditation training program on depressive symptoms.

Secondary Objectives

* Investigate effects of the meditation training program on symptoms of anxiety, behavior (social isolation), psychophysiological processes related to health and disease (e.g., sleep). Test changes in behavior and psychophysiology as mechanisms of improved mental health. Test whether improved mental health is associated with improved academic outcomes.

Eligibility criteria: 1. Age 14 to 19
2. Currently in high school (i.e., 9th to 12th grade) or if not attending school, would be in high school if enrolled
3. Proficient in English
4. Able to understand and provide informed consent (greater than or equal to 18 years old) or assent and parent/guardian consent (if less than 18 years old)
5. PROMIS Depression Scale T-score greater than or equal to 60 or sum of Patient Health Questionnaire-2 (PHQ-2) greater than or equal to 2
6. If on a psychotropic meditation, has been receiving a stable dose for greater than or equal to 4 weeks
7. Willing and able to complete all study procedures

Exclusion Criteria:

1. Has received a high school diploma or a high school equivalency diploma (HSED or GED)
2. Weekly or more frequent meditation practice
3. Prior use of the Healthy Minds Program app
4. Prior use of the water tracking app
5. Endorses current suicidal thoughts on the baseline screen
6. Self-reported history of psychosis or mania
7. Currently receiving, history of receiving in the last 6 months, or planning to start any of the following types of therapy within the next 5 months: Acceptance Commitment Therapy (ACT), Dialectical Behavior Therapy (DBT), and other mindfulness-based therapies (e.g., Mindfulness-Based Cognitive Therapy). For history of receiving only, only excluded if the participants has used the techniques on a weekly more frequent basis in the last 6 months.

Primary outcomes:
measure: PROMIS Pediatric Depression T-Scores
timeFrame: 8 weeks, 20 weeks
Secondary outcomes:
measure: PROMIS Pediatric Anxiety T-Scores
timeFrame: 8 weeks, 20 weeks
measure: EPOCH Wellbeing Scores
timeFrame: 8 weeks, 20 weeks
measure: PROMIS Pediatric Sleep Disturbance T-Score
timeFrame: 8 weeks, 20 weeks
measure: Sleep Duration assessed with wearable device
timeFrame: Daily through 20 weeks
measure: Sleep Staging assessed with wearable device
timeFrame: Daily through 20 weeks
measure: Wake after sleep onset
timeFrame: Daily through 20 weeks
measure: Pulse Rate Variability (PRV) collected by a wearable sensor
timeFrame: Daily through 20 weeks
measure: Belonging Uncertainty Scale Score
timeFrame: 8 weeks, 20 weeks
measure: Drexel Defusion Teen Score
timeFrame: 8 weeks, 20 weeks
measure: NIH Toolbox - Emotional Battery Loneliness (Ages 8-17) Fixed Form
timeFrame: 8 weeks, 20 weeks
measure: Perseverative Thinking Questionnaire - Child Scores
timeFrame: 8 weeks, 20 weeks
measure: Healthy Minds Index
timeFrame: 8 weeks
measure: Five Facet Mindfulness Questionnaire 16-item Adolescent version
timeFrame: 8 weeks
measure: Attitudes Towards Online Psychological Interventions
timeFrame: 8 weeks
measure: Adverse Meditation Experience Questionnaire
timeFrame: 8 weeks, 20 weeks
Other outcomes:
measure: Digital Working Alliance Inventory
timeFrame: Weeks 2, 4, 6, 8 and 20.
measure: Growth mindset personality and intelligence
timeFrame: Baseline, week 8 and week 20.
measure: Problematic Internet Use Scale
timeFrame: Baseline, week 8 and week 20
measure: Daily diary of social interactions
timeFrame: Daily through 8 weeks
Locations:
city: Madison
country: United States
facility: Center for Healthy Minds, University of Wisconsin Madison
state: Wisconsin
Study officials:
affiliation: Center for Healthy Minds, UW Madison
name: Matthew Hirshberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: