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Not yet recruiting NCT07593443

Application for Arts-Based Social Prescribing

No phase Interventional Depression in Adolescence Anxiety Loneliness Social Connectedness

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: Art Pharmacy, Stable treatment.
Who it may be relevant to
Registry conditions: Depression in Adolescence, Anxiety, Loneliness, Social Connectedness. Basic parameters: 15 years — 18 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 →

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Official title

Member Engagement Application for Personalized Arts-based Social Prescriptions

Overview

The goal of this clinical trial is to learn if a personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app (SocialRx App) can improve mental health and social connectedness in adolescents aged 15-18 with depression or anxiety enrolled in Medicaid managed care. The main question it aims to answer is: Compared to stable treatment, does participation in the Art Pharmacy program through the SocialRx App improve depression, anxiety, social connectedness, and loneliness? Researchers will compare participants receiving the Art Pharmacy program and digital companion to those receiving stable treatment (no change to existing care) to evaluate its effects on mental health and social connectedness. Participants will: Be randomly assigned to either the Art Pharmacy program delivered through the SocialRx App or a control group receiving stable treatment. Complete online surveys at baseline and follow-up time points (e.g., 3, 6, 9, and 12 months). If assigned to the intervention group, Art Pharmacy, participants will receive monthly arts and cultural activity recommendations, attend activities, and interact with a care navigator delivered through the SocialRx App.

Interventions

  • Behavioral Art Pharmacy
    A personalized arts-based social prescribing program
  • Other Stable treatment
    Stable treatment (no change to existing care) through Medicaid managed care

Primary outcome measures

  • Anxiety - Generalized Anxiety Disorder-7 (GAD-7) [Time frame: At baseline, and 3-, 6-, 9- and 12-month follow up.]
  • Depression - Patient Health Questionnaire-9 Adolescent Version (PHQ-9A) [Time frame: At baseline, and 3-, 6-, 9- and 12-month follow up.]
  • Loneliness - UCLA Loneliness Scale [Time frame: At baseline, and 3-, 6-, 9-, and 12-month follow up]
  • Social Connectedness - Social Connectedness Scale-Revised (SCS-R) [Time frame: At baseline, and 3-, 6-, 9-, and 12-month follow up]
Secondary outcome measures (1)
  • Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire [Time frame: At baseline, and 3-, 6-, 9-, and 12-month follow up]

Eligibility criteria

Inclusion criteria

Participants must meet the following criteria:

  • Aged 15-18 years enrolled in Medicaid managed care
  • Positive screen for depression and/or anxiety (e.g., PHQ-2 or GAD-2 ≥ 3)
  • Currently own and easily operate a smartphone
  • Have a valid e-mail address checked regularly
  • English fluency, and
  • Have a stable treatment regimen for at least 30 days prior to baseline with no planned treatment changes.

Exclusion criteria

Participants will be excluded if they:

  • Endorse current suicidal ideation at study screening, defined as a response ≥ 1 ("several days") on Item 9 of the PHQ-9A
  • Initiate a new treatment regimen or plan on initiating a new treatment regimen (i.e., medication, psychotherapy, or mind-body interventions) at the time of enrollment.

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

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07593443 · 26.0599 · R44AT013552

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗