Application for Arts-Based Social Prescribing

NCT07593443 | Not Yet Recruiting DMC

• 2 other identifiers: 26.0599R44AT013552
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety; Loneliness; Depression in Adolescence; Social Connectedness

Outcome Measures

Primary Outcomes (4)

• Anxiety - Generalized Anxiety Disorder-7 (GAD-7)

  The GAD-7 is a 7-item self-report measure of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety severity.

  At baseline, and 3-, 6-, 9- and 12-month follow up.

• Depression - Patient Health Questionnaire-9 Adolescent Version (PHQ-9A)

  The PHQ-9A is a 9-item self-report measure of depressive symptoms in adolescents. Scores range from 0 to 27, with higher scores indicating greater depression severity.

  At baseline, and 3-, 6-, 9- and 12-month follow up.

• Loneliness - UCLA Loneliness Scale

  The UCLA Loneliness Scale assesses subjective feelings of loneliness and social isolation. Scores range from 20 - 80, with higher scores indicating a higher degree of loneliness.

  At baseline, and 3-, 6-, 9-, and 12-month follow up

• Social Connectedness - Social Connectedness Scale-Revised (SCS-R)

  The SCS-R measures feelings of interpersonal closeness and connectedness. Scores range from 20 to 120, with higher scores indicating greater social connectedness.

  At baseline, and 3-, 6-, 9-, and 12-month follow up

Secondary Outcomes (1)

• Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire

  At baseline, and 3-, 6-, 9-, and 12-month follow up

Study Arms (2)

Art Pharmacy program delivered through the SocialRx App

EXPERIMENTAL

A personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app, SocialRx App

Behavioral: Art Pharmacy

Stable treatment

ACTIVE COMPARATOR

Existing, stable treatment regimen without major changes

Other: Stable treatment

Interventions

Art Pharmacy BEHAVIORAL

A personalized arts-based social prescribing program

Art Pharmacy program delivered through the SocialRx App

Stable treatment OTHER

Stable treatment (no change to existing care) through Medicaid managed care

Stable treatment

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SocialRx Inc: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Boston College: collaborator

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Dawn McDaniel, PhD

  SocialRx Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Research & Evaluation Manager

CONTACT

845-807-8005; peter@socialrx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 18, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share