An interventional study of Just Do You and Active Control in Depression, Bipolar Disorder and Psychosis, sponsored by New York University. Completed at 1 site in United States. Open to participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by New York University · Not applicable, Interventional, and Other
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 13 studies in Depression by New York University — 5 open to participants now, 6 under way, none of them phase 3. Depression · New York University.
Among the 13 studies in Depression by New York University, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 13 with no phase, and was the 4th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →5 of the 13 studies in Depression by New York University are open now, in 2 countries. Recruiting first, the newest first:
New York University · Sites in United States
Ages 18+ · Women only
New York University · Sites in United States
Ages 18+ · Healthy volunteers
New York University · Sites in United States
Ages 12–19 · Healthy volunteers
New York University · Sites in United States
Ages 18+
New York University · Sites in United States, Korea, Republic of
Ages 18+
By country, each count listing its studies:
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 28 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
13 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 1 started in 2018.
This study's enrollment of 124 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 124 across the 13 interventional studies. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
New York University is the lead sponsor of 123 studies on the registry; 32 are open to participants now.
4 of the studies in Depression by New York University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05654207New York UniversityWeCare: A System of Care for Black Youth | 2027-04-01 |
| NCT04752618New York UniversitySafe Mothers, Safe Children Initiative | 2027-04-30 |
| NCT06262178New York UniversityParenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children | 2027-05-31 |
| NCT05461495New York UniversityNYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers | 2027-06-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 13 studies in Depression by New York University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care.
This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, we will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
Background
Young adults have elevated rates of serious mental illnesses and they often do not receive consistent mental health care. This is a considerable challenge for public health, as most often mental health conditions persist into adulthood. Continuing to engage this population in their professional mental health treatment has been a pervasive challenge globally. Few mental health interventions have been designed specifically for young adults and none are conceptualized as meta-interventions or orientation programs. Just Do You is a young-adult-centered and theoretically guided intervention that has shown promise for keeping young adults connected to their professional treatments, while also enhancing their hope for the future and their own recovery. Just Do You is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to address mistrust, lack of hope for the future, stigma concerns, literacy and a sense of efficacy early on when young adults begin a new service experience in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services).
Methods/design
This study utilizes a randomized controlled trial to test the preliminary impact of the intervention, compared to best available services (treatment as usual, TAU) at two outpatient programs for adults with serious mental illnesses (n = 195). The program was adapted to two-sessions from the piloted four-session version through conversations with leadership at partnering agencies. The intervention involves intensive staff training and 24 months of ongoing provision, monitoring and supervision of the program. Quantitative survey data will be collected at baseline (pre), 2 weeks (post), 1 month, and 3 months. In this intention-to-treat analysis, the investigators will conduct basic omnibus analyses to examine whether Just Do You leads to improved outcomes relative to TAU utilizing t tests across treatment conditions for each outcome measure specified. The investigators will likewise examine whether changes in the proposed mediating variables differ across groups.
Discussion
The aim of this study is to test Just Do You through a moderately-sized randomized trial in order to see if it improves initial and secondary engagement among young adults with serious mental health conditions. The program is designed as an orientation to services, coupled with a curriculum designed to enhance motivation and agency, and keep young adults connected to their care. Continuity of care among this population is a serious challenge and Just Do You has the potential to address this challenge in the service system for poor, young adults living in low-resourced communities. If it is shown to be successful in this setting, it could likely be used to address the continuity of care issue more broadly in additional settings that serve young adults with serious mental illness. It may enhance the menu of care options for those who have been recently diagnosed with a serious mental health condition, providing them with an orientation for how professional mental health care can help them. The program is recovery-oriented, builds on the best evidence to date, and is in line with both local and national health care reform efforts.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to the experimental arm will be enrolled in the 2-session Just Do You intervention described elsewhere.
Behavioral: Just Do You
Participants assigned to treatment as usual will receive the PROS program that is standard in the agencies without any additional intervention.
Participants assigned to the active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population.
Behavioral: Active Control
Just Do You is an intervention designed to keep young adults connected to their professional behavioral health treatments. It is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to increase young adult engagement in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The first session consists of the following components: 1) Welcome; Group Guidelines, Purpose, 2) Discuss Recovery Principles; Narrative of Role Model; 3) Video of Celebrity Service User and Discussion, and 4) Recovery Goals (and role of services in that). The second session consists of: 1) What are services \& how can they help? 2) Visual art exercise -- Cause of SMI and validation, 3) Maintaining my Medicaid Insurance, and 4) Discussion of Systemic Barriers.
The active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population.
Adherence to PROS program
Past week attendance to mental health appointments at PROS
Time frame: Assessed 4 weeks following baseline
Adherence to PROS program
Past week attendance to mental health appointments at PROS
Time frame: Assessed 3 months following baseline
Adherence to medication
Past week adherence to mental health-related medications
Time frame: Assessed 4 weeks following baseline
Adherence to medication
Past week adherence to mental health-related medications
Time frame: Assessed 3 months following baseline
Client Engagement in Child Protective Services Scale
This scale is altered to measure young adult engagement in PROS services. The scale includes 8 questions and responses will be summed. The range for the scale is 8 to 40, with higher scores indicating higher levels of engagement.
Time frame: Assessed 4 weeks following baseline
Client Engagement in Child Protective Services Scale
This scale is altered to measure young adult engagement in PROS services. The scale includes 8 questions and responses will be summed. The range for the scale is 8 to 40, with higher scores indicating higher levels of engagement.
Time frame: Assessed 3 months following baseline
Center for Epidemiological Studies Depression Scale
This is a standardized measure of depression. The range on the scale is 0 to 60. Scores will be summed. Higher scores indicated higher levels of depression.
Time frame: Assessed 3 months following baseline
Global Measure of Perceived Stress
This is a standardized measure of recent stress. The range on the scale is 0 to 56. Scores will be summed. Higher scores indicated higher levels of stress.
Time frame: Assessed 4 weeks following baseline
Inventory of Attitudes Toward Seeking Mental Health Services
The investigators will use the stigma subscale of the Inventory of Attitudes Toward Seeking Mental Health Services. The range of the measure is 0 to 48, with higher scores indicating higher levels of stigma. For this study the score will be summed.
Time frame: Assessed 4 weeks following baseline
Inventory of Attitudes Toward Seeking Mental Health Services
The investigators will use the stigma subscale of the Inventory of Attitudes Toward Seeking Mental Health Services. The range of the measure is 0 to 48, with higher scores indicating higher levels of stigma. For this study the score will be summed.
Time frame: Assessed 3 months following baseline
Group-Based Medical Mistrust Scale
Standardized measure of mistrust of mental health services. The range for the measure is 4 to 20. For this study the scores will be summed, with higher scores indicating more mistrust.
Time frame: Assessed 4 weeks following baseline
Group-Based Medical Mistrust Scale
Standardized measure of mistrust of mental health services. The range for the measure is 4 to 20. For this study the scores will be summed, with higher scores indicating more mistrust.
Time frame: Assessed 3 months following baseline
The Hope Scale
This is a standardized measure of hope. The scores will be summed. The range is 8 to 96, with higher scores indicating higher levels of hope.
Time frame: Assessed 4 weeks following baseline
The Hope Scale
This is a standardized measure of hope. The scores will be summed. The range is 8 to 96, with higher scores indicating higher levels of hope.
Time frame: Assessed 3 months following baseline
Self-Efficacy/Advocacy
Perceived Behavioral Control (4-items adapted from autonomy factor and 3-items from capacity factor). The scores will be summed. For the autonomy factor, the range is 4 to 16, with higher scores indicating more control and autonomy. For the capacity factor, the range is 3 to 12, with higher scores indicating less capacity.
Time frame: Assessed 4 weeks following baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Mar 2020, 25 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 25 months is above that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.