Suicide, AttemptedNCT05183230
WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt
A study testing WellPATH-PREVENT and Optimized WellPATH-PREVENT in people with Suicide, Attempted and Suicidal Ideation, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation, Depression
- What is being tested?
- WellPATH-PREVENT and Optimized WellPATH-PREVENT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2022to 30 Sep 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-90 years old
- Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis of Dementia
- Recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific Active Suicidal Thoughts."
- We will also include patients on psychotropics and on after-care community psychotherapy.
Who cannot join
- Current diagnosis of Psychotic Disorders; Diagnosis of Dementia
- Cognitive Impairment (MMSE ≤ 24)
- Acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry
- Aphasia, sensory problems, and/or inability to speak English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
New York Presbyterian Hospital/Weill Cornell Medicine
New York, New York, 10065
Dimitris Kiosses, PhD, 914-997-4381, dkiosses@med.cornell.edu
Laurie Evans, MS, 914-682-9100 ext. 1012570, lad9011@med.cornell.edu
- Recruiting
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
White Plains, New York, 10605
Dimitris Kiosses, PhD, 914-997-4381, dkiosses@med.cornell.edu
Laurie Evans, MS, 914-682-9100 ext. 1012570, lad9011@med.cornell.edu
About this study
The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).
Read the detailed description
R61 Phase: In this "proof-of-concept" phase, interventionists will administer 12 weeks of WellPATH-PREVENT in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. The interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. There will be 4 assessments: At study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. An EEG will be conducted upon entry into the study, at Week 6, and at Week 12.
R33 Phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of WellPATH-PREVENT (Week 6 and Week 12 duration based on R61 results) or to Attention Control-Usual Care with a tablet (AC-UC). There will be 5 assessments: At study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. Participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. Psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.
- Conditions
- Suicide, Attempted, Suicidal Ideation, Depression
- Being tested
- WellPATH-PREVENT, Optimized WellPATH-PREVENT
- Keywords
- Older Adults, Middle Aged Adults
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellPATH-PREVENTBehavioural
WellPATH-PREVENT is a novel personalized, easy to use, mainly stand-alone mobile intervention which focuses on the exclusive use of the WellPATH tablet app and includes training meetings during hospitalization, and virtual post-discharge coaching meetings. The meetings aim to: a) identify stressors and triggers of negative emotions associated with increased suicidal ideation or with suicidal behavior; b) develop techniques (text or video) to increase cognitive reappraisal ability; c) incorporate the techniques into the WellPATH app and promote the use of WellPATH during stressful incidents, triggers of negative emotions, or scheduled brief training sessions; and d) remotely update the triggers, negative emotions, and techniques in the app.
Optimized WellPATH-PREVENTBehavioural
The Optimized WellPATH-PREVENT intervention will be as described above, but based on the results of the Proof-of-Concept (R61) Phase, an expert committee will help select the duration (6 or 12 weeks) that shows greater improvement in cognitive reappraisal.
| Study group | Role | What they receive |
|---|---|---|
| Proof-of-Concept WellPATH-PREVENT (R61) | Experimental | Not described Receives: Behavioral: WellPATH-PREVENT |
| Optimized WellPATH-PREVENT (R33) | Experimental | Not described Receives: Behavioral: Optimized WellPATH-PREVENT |
| Attention Control Usual Care (R33) | No intervention | The AC-UC group will parallel the delivery of the WellPATH-PREVENT intervention and will also include: a) meetings during hospitalization: a non-clinical member of the team will present the control tablet and explain its use; b) scheduled or requested meetings through zoom: to parallel the delivery of WellPATH-PREVENT. The tablet will still have a link to schedule a meeting with a non-clinician member of the team. The meetings will focus on issues that the patient may have in using the tablet. There will not be any therapeutic or psychological interaction between participants in the control group and the team. The experimental and the control group will also be under usual outpatient care, which is arranged during the hospitalization by the inpatient treatment team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Measured: Study Entry, Week 6, Week 12
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Measured: Study Entry, Week 6, Week 12, Week 24
Change in Self-Reported Affect - R61
Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.
Measured: Study Entry, Week 6, Week 12
Change in Self-Reported Affect - R33
Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.
Measured: Study Entry, Week 6, Week 12, Week 24
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.
Measured: Study Entry, Week 6, Week 12
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.
Measured: Study Entry, Week 6, Week 12, Week 24
Change in Client Satisfaction with Treatment (CSQ) - R61
Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.
Measured: Week 6, Week 12
Change in Client Satisfaction with Treatment (CSQ) - R33
Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.
Measured: Week 6, Week 12, Week 24
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Measured: Weekly from Study Entry to Week 12 (R61)
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Measured: Weekly from Study Entry to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start22 Apr 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Dimitris Kiosses, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183230
- Sponsor's protocol ID
- 21-12024207
- Other IDs
- R61MH128516, R33MH128516
- Status last verified
- Sep 2026
- First submitted
- 20 Dec 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt
- ClinicalTrials.gov ID
- NCT05183230
- Acronym / sponsor ID
- 21-12024207
- Conditions
- Suicide, Attempted, Suicidal Ideation, Depression
- Keywords
- Older Adults, Middle Aged Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Jan 2022 (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 project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).
Detailed description
R61 Phase: In this "proof-of-concept" phase, interventionists will administer 12 weeks of WellPATH-PREVENT in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. The interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. There will be 4 assessments: At study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. An EEG will be conducted upon entry into the study, at Week 6, and at Week 12.
R33 Phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of WellPATH-PREVENT (Week 6 and Week 12 duration based on R61 results) or to Attention Control-Usual Care with a tablet (AC-UC). There will be 5 assessments: At study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. Participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. Psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proof-of-Concept WellPATH-PREVENT (R61) | Experimental | Behavioral: WellPATH-PREVENT |
| Optimized WellPATH-PREVENT (R33) | Experimental | Behavioral: Optimized WellPATH-PREVENT |
| Attention Control Usual Care (R33) | No intervention | –The AC-UC group will parallel the delivery of the WellPATH-PREVENT intervention and will also include: a) meetings during hospitalization: a non-clinical member of the team will present the control tablet and explain its use; b) scheduled or requested meetings through zoom: to parallel the delivery of WellPATH-PREVENT. The tablet will still have a link to schedule a meeting with a non-clinician member of the team. The meetings will focus on issues that the patient may have in using the tablet. There will not be any therapeutic or psychological interaction between participants in the control group and the team. The experimental and the control group will also be under usual outpatient care, which is arranged during the hospitalization by the inpatient treatment team. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50-90 years old
- Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis of Dementia
- Recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific Active Suicidal Thoughts."
- We will also include patients on psychotropics and on after-care community psychotherapy.
Key exclusion criteria (4 listed)
- Current diagnosis of Psychotic Disorders; Diagnosis of Dementia
- Cognitive Impairment (MMSE ≤ 24)
- Acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry
- Aphasia, sensory problems, and/or inability to speak English.
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 |
|---|---|---|
| WellPATH-PREVENTWellPATH-PREVENT is a novel personalized, easy to use, mainly stand-alone mobile intervention which focuses on the exclusive use of the WellPATH tablet app and includes training meetings during hospitalization, and virtual post-discharge coaching meetings. The meetings aim to: a) identify stressors and triggers of negative emotions associated with increased suicidal ideation or with suicidal behavior; b) develop techniques (text or video) to increase cognitive reappraisal ability; c) incorporate the techniques into the WellPATH app and promote the use of WellPATH during stressful incidents, triggers of negative emotions, or scheduled brief training sessions; and d) remotely update the triggers, negative emotions, and techniques in the app. | Behavioural | Proof-of-Concept WellPATH-PREVENT (R61) |
| Optimized WellPATH-PREVENTThe Optimized WellPATH-PREVENT intervention will be as described above, but based on the results of the Proof-of-Concept (R61) Phase, an expert committee will help select the duration (6 or 12 weeks) that shows greater improvement in cognitive reappraisal. | Behavioural | Optimized WellPATH-PREVENT (R33) |
Primary outcome
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61
Time frame: Study Entry, Week 6, Week 12
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
Time frame: Study Entry, Week 6, Week 12, Week 24
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Change in Self-Reported Affect - R61
Time frame: Study Entry, Week 6, Week 12
Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.
Change in Self-Reported Affect - R33
Time frame: Study Entry, Week 6, Week 12, Week 24
Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
Time frame: Study Entry, Week 6, Week 12
ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
Time frame: Study Entry, Week 6, Week 12, Week 24
ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.
Change in Client Satisfaction with Treatment (CSQ) - R61
Time frame: Week 6, Week 12
Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.
Change in Client Satisfaction with Treatment (CSQ) - R33
Time frame: Week 6, Week 12, Week 24
Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
Time frame: Weekly from Study Entry to Week 12 (R61)
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
Time frame: Weekly from Study Entry to Week 24
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
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 23 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
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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.
Dimitris Kiosses, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WellPATH-PREVENT and Optimized WellPATH-PREVENT in people with Suicide, Attempted and Suicidal Ideation, run by Weill Medical College of Cornell University at 2 sites 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 4 inclusion and 4 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 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Dimitris Kiosses, PhD (914-997-4381, dkiosses@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61 (time frame: Study Entry, Week 6, Week 12). The study lists 10 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 23 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.