What side effects are associated with this type of intervention?

Psychosocial interventions like cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), which are similar to the WellPATH-PREVENT approach, generally have minimal physical side effects but can sometimes lead to emotional discomfort as patients confront distressing thoughts and feelings. Pharmacotherapy options, such as antidepressants and mood stabilizers, may be used alongside these therapies and can have side effects including nausea, weight gain, sleep disturbances, and, in some cases, increased anxiety or agitation. It is important for patients to discuss these potential side effects with their healthcare provider to tailor the treatment plan to their individual needs.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs solely for the treatment of suicide attempts. However, certain medications, such as antidepressants (e.g., SSRIs like fluoxetine), have been used to manage underlying conditions like depression, which can reduce suicide risk. Cognitive reappraisal ability, targeted in the WellPATH-PREVENT trial, is typically enhanced through psychosocial interventions rather than pharmacotherapy. Therefore, while there are no direct FDA-approved drugs for suicide attempts, treatments for related mental health conditions are utilized to mitigate risk.

What other types of research exist?

Promising novel alternatives to WellPATH-PREVENT for suicide attempt patients include: 1) Texting 4 Relapse Prevention (T4RP), a text messaging-based program that has shown high acceptability and support among patients with schizophrenia and schizoaffective disorder, which could be adapted for broader use in suicide prevention. 2) Collaborative care management models that integrate behavioral health professionals into primary care settings to provide continuous support and monitoring. 3) Mobile apps designed for cognitive behavioral therapy (CBT) and dialectical behavior therapy (DBT) that offer real-time coping strategies and crisis intervention. 4) Virtual reality (VR) therapy, which provides immersive environments for practicing emotion regulation and stress reduction techniques.

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Mobile Intervention for Suicidal Thoughts

N/A

Recruiting

Led By Dimitris Kiosses, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

50-90 years old

Be older than 18 years old

Must not have

Current diagnosis of Psychotic Disorders

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, week 12, week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests WellPATH-PREVENT, a tablet-based program, to help adults aged 50-90 manage emotions and reduce suicide risk. The program teaches recognizing emotional triggers and changing negative thoughts into positive ones.

Who is the study for?

This trial is for middle-aged and older adults aged 50-90 who have been hospitalized due to suicidal thoughts or attempts. Participants must be able to understand English, not suffer from severe cognitive impairments (MMSE > 24), psychotic disorders, dementia, or acute medical illnesses.

What is being tested?

The study tests WellPATH-PREVENT, a mobile psychosocial intervention aimed at improving emotion regulation and reducing suicide risk in participants recently discharged after hospitalization for suicide-related issues.

What are the potential side effects?

Since WellPATH-PREVENT is a psychosocial intervention rather than a medication, it may not have typical drug side effects. However, participants might experience emotional discomfort when discussing sensitive topics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a psychotic disorder.

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I have not had a severe illness or major surgery in the last 3 months.

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I have been diagnosed with dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, week 12, week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, week 12, week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, week 12, week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Client Satisfaction with Treatment (CSQ) - R33

Change in Client Satisfaction with Treatment (CSQ) - R61

Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Proof-of-Concept WellPATH-PREVENT (R61)Experimental Treatment1 Intervention

Group II: Optimized WellPATH-PREVENT (R33)Experimental Treatment1 Intervention

Group III: Attention Control Usual Care (R33)Active Control1 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The WellPATH-PREVENT trial focuses on a mobile psychosocial intervention designed to enhance cognitive reappraisal ability, which is a key mechanism in many treatments for suicide attempt patients. Cognitive reappraisal involves changing the way one thinks about potentially distressing situations to alter their emotional impact. This mechanism is crucial because it helps patients manage negative emotions and reduce impulsive behaviors that can lead to suicide attempts. By improving cognitive reappraisal, patients can develop healthier coping strategies, thereby reducing their overall suicide risk.