Depression in AdolescenceNCT07593443
Application for Arts-Based Social Prescribing
A study testing Art Pharmacy and Stable treatment in people with Depression in Adolescence and Anxiety, run by SocialRx Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Depression in Adolescence, Anxiety, Loneliness
- What is being tested?
- Art Pharmacy and Stable treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Member Engagement Application for Personalized Arts-based Social Prescriptions
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:
Read more
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
- Depression in Adolescence, Anxiety, Loneliness, Social Connectedness
- Being tested
- Art Pharmacy, Stable treatment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art PharmacyBehavioural
A personalized arts-based social prescribing program
Stable treatmentOther
Stable treatment (no change to existing care) through Medicaid managed care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Art Pharmacy |
| Stable treatment | Active comparator | Existing, stable treatment regimen without major changes Receives: Other: Stable treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, and 3-, 6-, 9-, and 12-month follow up
Secondary 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.
Measured: At baseline, and 3-, 6-, 9-, and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SocialRx Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Boston College
- Responsible party
- Principal investigator, Dawn McDaniel, SocialRx Inc
- Investigators
- Dawn McDaniel, PhD, Principal investigator, SocialRx Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593443
- Sponsor's protocol ID
- 26.0599
- Other IDs
- R44AT013552
- Status last verified
- May 2026
- First submitted
- 10 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Member Engagement Application for Personalized Arts-based Social Prescriptions
- ClinicalTrials.gov ID
- NCT07593443
- Acronym / sponsor ID
- 26.0599
- Conditions
- Depression in Adolescence, Anxiety, Loneliness, Social Connectedness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- SocialRx IncIndustry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Boston College
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Pharmacy program delivered through the SocialRx App | Experimental | Behavioral: Art PharmacyA personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app, SocialRx App |
| Stable treatment | Active comparator | Other: Stable treatmentExisting, stable treatment regimen without major changes |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art PharmacyA personalized arts-based social prescribing program | Behavioural | Art Pharmacy program delivered through the SocialRx App |
| Stable treatmentStable treatment (no change to existing care) through Medicaid managed care | Other | Stable treatment |
Primary outcome
Anxiety - Generalized Anxiety Disorder-7 (GAD-7)
Time frame: At baseline, and 3-, 6-, 9- and 12-month follow up.
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.
Depression - Patient Health Questionnaire-9 Adolescent Version (PHQ-9A)
Time frame: At baseline, and 3-, 6-, 9- and 12-month follow up.
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.
Loneliness - UCLA Loneliness Scale
Time frame: At baseline, and 3-, 6-, 9-, and 12-month follow up
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.
Social Connectedness - Social Connectedness Scale-Revised (SCS-R)
Time frame: At baseline, and 3-, 6-, 9-, and 12-month follow up
The SCS-R measures feelings of interpersonal closeness and connectedness. Scores range from 20 to 120, with higher scores indicating greater social connectedness.
1 secondary outcome
Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire
Time frame: At baseline, and 3-, 6-, 9-, and 12-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dawn McDaniel, PhD principal investigator
SocialRx Inc
Questions about this trial
What is this clinical trial studying?
A study testing Art Pharmacy and Stable treatment in people with Depression in Adolescence and Anxiety, run by SocialRx Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Research & Evaluation Manager (845-807-8005, peter@socialrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety - Generalized Anxiety Disorder-7 (GAD-7) (time frame: At baseline, and 3-, 6-, 9- and 12-month follow up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.