Application for Arts-Based Social Prescribing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-18
SponsorSocialRx Inc
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Art Pharmacy
BehavioralA personalized arts-based social prescribing program
Stable treatment
Other interventionStable treatment (no change to existing care) through Medicaid managed care
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Art Pharmacy program delivered through the SocialRx AppExperimental treatment 1 intervention
Group B: Stable treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline, and 3-, 6-, 9- and 12-month follow up.2
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.
Time frame
At baseline, and 3-, 6-, 9- and 12-month follow up.3
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.
Time frame
At baseline, and 3-, 6-, 9-, and 12-month follow up4
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.
Time frame
At baseline, and 3-, 6-, 9-, and 12-month follow upSecondary outcomes
1
Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire
A study-developed questionnaire assessing participant engagement with behavioral health treatment and arts/cultural activities. Higher scores/frequencies indicate greater utilization and engagement.
Time frame
At baseline, and 3-, 6-, 9-, and 12-month follow upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SocialRx Inc
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Boston College
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: