Suicidal IdeationRISENCT07051200
Recovery Through Inspiration, Support, and Empowerment
A study testing Peer Support Services Recovery in people with Suicidal Ideation and Suicide Attempt, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. Read more about this study
- Who is it for?
- Ages 18 to 27 years
- Conditions the study is for
- Suicidal Ideation, Suicide Attempt, Anxiety
- What is being tested?
- Peer Support Services Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Dec 2027
- 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 18 to 27 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
- discharged from inpatient care or from emergency department
- men and women ages 18-27
Who cannot join
- primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources.
Read more
The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO).
Participants will be assigned to either Cohort A or B for 8 weeks.
Cohort A will be the intervention group with PSS and RCOs.
- Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4.
- Weeks 5 and 7: One-on-one meetings with PSS for education and support.
- Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks.
Cohort B will be the SOC group with no PSS or RCOs.
- Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4.
- Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8.
Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
Read the detailed description
Purpose
- This is a pilot study to test the effectiveness of a novel intervention aimed at reducing the incidences of suicidality, depression, anxiety, re-hospitalization rates, and improving mental health recovery by utilizing outpatient services, and medication adherence for young adults (18-27) with mental health conditions verses the standard of care (SOC) at discharge which only provides a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.
- The intervention will use peer support specialist (PSS) and recovery community organizations (RCO) aimed at improving knowledge, awareness, and utilization of recovery and wellness programs for those patients recently discharged from an acute psychiatric treatment facility.
Objectives
- Implement a program of mental health recovery education and support through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility to determine the effectiveness of: Reduction of suicidality, depression, anxiety, re-hospitalization rate AND Improvement in mental health recovery by participating in outpatient services, and medication adherence.
- Determine if peer-led interventions improve knowledge, awareness, and utilization of recovery and wellness programs and support.
Endpoints
- Determine the efficacy of peer-led, one-on-one and group sessions vs standard of care (SOC) based on responses to assessments, adherence to medication, and re-admittance to a psychiatric facility.
- Determine if there is a difference in outcome based on demographics (age, race, ethnic background, diagnosis, public vs private insurance, and zip code)
Study Design This is a 1:1 randomized, 8-week interventional study that will include an orientation session and a collection of baseline data. At the conclusion of the orientation session, subjects will be randomly assigned to Cohort A or B. Target recruitment is 40 subjects for this pilot study; 20 subjects in cohort A and 20 in cohort B. At the conclusion of the study, both groups will be provided a list of resources for therapy, outpatient psychiatry providers/services, RCOs, local emergency departments and inpatient psychiatric facilities.
Cohort A - Intervention group with PSS and RCOs
- Weeks 1-4: one-on-one meetings with peer support specialist (PSS) for education and support. Qualitative and quantitative assessments completed at weeks 2 and 4
- Weeks 5-8: Biweekly (every other week) of one-on-one meetings with PSS for education and support. Biweekly group meetings with PSS and other participants. Qualitative and quantitative assessments completed at weeks 6 and 8
Cohort B - SOC group with no PSS or RCOs; participants are responsible for finding resources or group support by following the information provided at discharge
- Weeks 1-4: Weekly check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 2 and 4 (completed during phone call check in)
- Weeks 5-8: Biweekly (every other week) check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 6 and 8 (completed during phone call check in).
- Conditions
- Suicidal Ideation, Suicide Attempt, Anxiety, Depression Disorders
- Being tested
- Peer Support Services Recovery
- Keywords
- Peer Support Specialist (PSS), Recovery Community Organization (RCO), Mental Health Recovery, Transitional Age Youth (TAY), UT Southwestern Medical Center, Young Adult
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Support Services RecoveryBehavioural
A program of mental health recovery through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Intervention group with PSS and RCOs | Experimental | One on one meetings peer support specialist (PSS) for education and support. Group meetings with PSS and other participants. Qualitative and quantitative assessments. Receives: Behavioral: Peer Support Services Recovery |
| Cohort B: Standard of Care | No intervention | Scheduled telephone call visit with a member of the research team. Qualitative and quantitative assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation
The intervention in this study will use peer support specialist (PSS) and recovery community organization (RCO) programs to improve knowledge, awareness, and utilization of recovery and wellness programs.
Connecting patients with a PSS and recovery organizations has been associated with an improvement in patient outcomes - including a change in the incidences of suicide/attempted suicide.
Changes in suicide ideation and consequently the mortality from suicide will be determine by administrating the Columbia Suicide Severity Rating Scale (C-SSRS) using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity.
Changes is scores will be analyzed to determine the effectiveness of the intervention.
Measured: Weeks 2, 4, 6, and 8.
Secondary outcomes (1)
Changes in symptoms associated with anxiety and depression
A reduction of anxiety and depression symptoms and rates of occurrence will be measured using the following standardized assessments:
- Generalized Anxiety Disorder (GAD) 7 - a widely used screening tool for assessing the severity of generalized anxiety disorder (GAD) and consists of 7 items that evaluate anxiety symptoms over the past two weeks.
- The Patient Health Questionnaire (PHQ) - a self reported inventory used as a screening and diagnostic tool for depression.
Responses on each assessment at each time point specified in the protocol, will be reviewed for changes (as indicating by the scoring of frequency or severity) to determine the efficacy of the intervention.
Measured: Weeks 2, 4, 6 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Model description
- Cohort A: Intervention Group Cohort B: Standard of Care
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Guillory, University of Texas Southwestern Medical Center
- Investigators
- Joseph Guillory, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051200
- Sponsor's protocol ID
- STU-2024-0135
- Acronym
- RISE
- Status last verified
- Jun 2026
- First submitted
- 30 Apr 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time - there is no intention of sharing individual participant data as this is a pilot study, and due to the relatively small number of participants, any data that is shared or published will be in aggregate.
Publications
Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.
PubMed 22654945Walker G, Bryant W. Peer support in adult mental health services: a metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013 Mar;36(1):28-34. doi: 10.1037/h0094744.
PubMed 23477647Lyons N, Cooper C, Lloyd-Evans B. A systematic review and meta-analysis of group peer support interventions for people experiencing mental health conditions. BMC Psychiatry. 2021 Jun 23;21(1):315. doi: 10.1186/s12888-021-03321-z.
PubMed 34162340
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Through Inspiration, Support, and Empowerment
- ClinicalTrials.gov ID
- NCT07051200
- Acronym / sponsor ID
- RISE / STU-2024-0135
- Conditions
- Suicidal Ideation, Suicide Attempt, Anxiety, Depression Disorders
- Keywords
- Peer Support Specialist (PSS), Recovery Community Organization (RCO), Mental Health Recovery, Transitional Age Youth (TAY), UT Southwestern Medical Center, Young Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Jul 2025 (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 pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services.
The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources.
The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO).
Participants will be assigned to either Cohort A or B for 8 weeks.
Cohort A will be the intervention group with PSS and RCOs.
- Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4.
- Weeks 5 and 7: One-on-one meetings with PSS for education and support.
- Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks.
Cohort B will be the SOC group with no PSS or RCOs.
- Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4.
- Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8.
Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
Detailed description
Purpose
- This is a pilot study to test the effectiveness of a novel intervention aimed at reducing the incidences of suicidality, depression, anxiety, re-hospitalization rates, and improving mental health recovery by utilizing outpatient services, and medication adherence for young adults (18-27) with mental health conditions verses the standard of care (SOC) at discharge which only provides a discharge plan with a list of their medication(s), anticipated outpatient appointment(s), and corresponding information on when and where to find community resources.
- The intervention will use peer support specialist (PSS) and recovery community organizations (RCO) aimed at improving knowledge, awareness, and utilization of recovery and wellness programs for those patients recently discharged from an acute psychiatric treatment facility.
Objectives
- Implement a program of mental health recovery education and support through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility to determine the effectiveness of: Reduction of suicidality, depression, anxiety, re-hospitalization rate AND Improvement in mental health recovery by participating in outpatient services, and medication adherence.
- Determine if peer-led interventions improve knowledge, awareness, and utilization of recovery and wellness programs and support.
Endpoints
- Determine the efficacy of peer-led, one-on-one and group sessions vs standard of care (SOC) based on responses to assessments, adherence to medication, and re-admittance to a psychiatric facility.
- Determine if there is a difference in outcome based on demographics (age, race, ethnic background, diagnosis, public vs private insurance, and zip code)
Study Design This is a 1:1 randomized, 8-week interventional study that will include an orientation session and a collection of baseline data. At the conclusion of the orientation session, subjects will be randomly assigned to Cohort A or B. Target recruitment is 40 subjects for this pilot study; 20 subjects in cohort A and 20 in cohort B. At the conclusion of the study, both groups will be provided a list of resources for therapy, outpatient psychiatry providers/services, RCOs, local emergency departments and inpatient psychiatric facilities.
Cohort A - Intervention group with PSS and RCOs
- Weeks 1-4: one-on-one meetings with peer support specialist (PSS) for education and support. Qualitative and quantitative assessments completed at weeks 2 and 4
- Weeks 5-8: Biweekly (every other week) of one-on-one meetings with PSS for education and support. Biweekly group meetings with PSS and other participants. Qualitative and quantitative assessments completed at weeks 6 and 8
Cohort B - SOC group with no PSS or RCOs; participants are responsible for finding resources or group support by following the information provided at discharge
- Weeks 1-4: Weekly check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 2 and 4 (completed during phone call check in)
- Weeks 5-8: Biweekly (every other week) check-in phone calls with a member of the research team. Qualitative and quantitative assessments completed at weeks 6 and 8 (completed during phone call check in).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cohort A: Intervention Group Cohort B: Standard of Care
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Intervention group with PSS and RCOs | Experimental | Behavioral: Peer Support Services RecoveryOne on one meetings peer support specialist (PSS) for education and support. Group meetings with PSS and other participants. Qualitative and quantitative assessments. |
| Cohort B: Standard of Care | No intervention | –Scheduled telephone call visit with a member of the research team. Qualitative and quantitative assessments. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
- discharged from inpatient care or from emergency department
- men and women ages 18-27
Key exclusion criteria (1 listed)
- primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III)
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 |
|---|---|---|
| Peer Support Services RecoveryA program of mental health recovery through one-on-one and small group meetings with a PSS and RCOs for individuals recently discharged from an acute care psychiatric facility. | Behavioural | Cohort A: Intervention group with PSS and RCOs |
Primary outcome
Change in suicidal ideation
Time frame: Weeks 2, 4, 6, and 8.
The intervention in this study will use peer support specialist (PSS) and recovery community organization (RCO) programs to improve knowledge, awareness, and utilization of recovery and wellness programs. Connecting patients with a PSS and recovery organizations has been associated with an improvement in patient outcomes - including a change in the incidences of suicide/attempted suicide. Changes in suicide ideation and consequently the mortality from suicide will be determine by administrating the Columbia Suicide Severity Rating Scale (C-SSRS) using both the baseline and since last visit assessment versions. Scoring of the assessment indicates severity. Changes is scores will be analyzed to determine the effectiveness of the intervention.
1 secondary outcome
Changes in symptoms associated with anxiety and depression
Time frame: Weeks 2, 4, 6 and 8
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 25 Jun 2026.
- Background: PubMed 22654945Davidson L, Bellamy C, Guy K, Miller R. Peer support among persons with severe mental illnesses: a review of evidence and experience. World Psychiatry. 2012 Jun;11(2):123-8. doi: 10.1016/j.wpsyc.2012.05.009.
- Background: PubMed 23477647Walker G, Bryant W. Peer support in adult mental health services: a metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013 Mar;36(1):28-34. doi: 10.1037/h0094744.
- Background: PubMed 34162340Lyons N, Cooper C, Lloyd-Evans B. A systematic review and meta-analysis of group peer support interventions for people experiencing mental health conditions. BMC Psychiatry. 2021 Jun 23;21(1):315. doi: 10.1186/s12888-021-03321-z.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. At this time - there is no intention of sharing individual participant data as this is a pilot study, and due to the relatively small number of participants, any data that is shared or published will be in aggregate.
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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.
Joseph Guillory, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Support Services Recovery in people with Suicidal Ideation and Suicide Attempt, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Noureen Hoq (214-648-0311, noureen.hoq@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation (time frame: Weeks 2, 4, 6, and 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07051200, which also lists 3 linked publications.
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 25 Jun 2026.