Cognitive Reappraisal for Suicide Prevention

(CRISP Trial)

Overseen By Laurie Evans, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Psychotropics

Disqualifiers: Psychotic disorders, Bipolar I/II, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help middle-aged and older adults manage emotions and reduce suicide risk. It features the Cognitive Reappraisal Intervention for Suicide Prevention, a program that teaches participants to change their perspectives and reactions using tools like notes and apps. The trial also compares this method with Supportive Therapy, which emphasizes expressing feelings and finding positive experiences. It seeks individuals who have been hospitalized for suicidal thoughts or attempts and have depression or anxiety. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new suicide prevention strategies.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, patients who are on psychotropics and receiving community psychotherapy are included, so it seems you can continue your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, 56% of participants completed 12 weeks of the Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) without reporting any suicidal thoughts. However, 19% experienced an increase in suicidal thoughts. CRISP aims to help individuals manage emotions by changing their thought patterns to improve feelings. Some participants also received tools like notes and checklists, along with support through phone calls and a tablet app. While many responded well to the treatment, a small number faced increased challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) because it offers a fresh approach to reducing suicide risk by focusing on emotion regulation techniques. Unlike traditional therapies that often rely on medication or talk therapy alone, CRISP teaches individuals to change their perspective and thought patterns to improve emotional reactions. It combines these cognitive strategies with practical tools like environmental adaptation aids and a supportive tablet app called WellPATH, providing a comprehensive support system. This innovative blend of techniques aims to empower individuals to manage their emotions more effectively, which could lead to a significant reduction in suicide risk.

What evidence suggests that this trial's treatments could be effective for reducing suicide risk?

Research has shown that the Cognitive Reappraisal Intervention for Suicide Prevention (CRISP), one of the treatments in this trial, might help lower the risk of suicide. This method focuses on changing how people think about their emotions, which can improve their feelings and responses. Previous studies have found similar methods promising in reducing suicidal thoughts by helping people manage their emotions better. The intervention also uses tools like notes, checklists, and a tablet app to aid emotional adjustment. These strategies aim to create a more stable emotional environment for individuals hospitalized for suicidal thoughts or attempts. Another treatment arm in this trial involves Supportive Therapy, which facilitates the expression of affect, conveys understanding, offers empathy, and highlights positive experiences. ^{1 2 3 5 6}

Who Is on the Research Team?

Dimitris Kiosses, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults aged 50-90 who have recently been hospitalized for suicidal thoughts or attempts. Participants must have a diagnosis of depression or anxiety, be on psychotropics, and receiving community psychotherapy. Excluded are those with psychotic disorders, bipolar I/II in manic states, dementia, severe medical issues, or language/sensory barriers.

Inclusion Criteria

I have been diagnosed with depression or anxiety.

Recent hospitalization for suicidal ideation or suicide attempt with specific criteria

Patients with any degree of suicidal ideation at discharge

Exclusion Criteria

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

History or current diagnosis of Psychotic Disorders

I have been diagnosed with Bipolar I or II and am currently experiencing a hypomanic, manic, or mixed episode.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Treatment

Certified social workers administer 12 weekly sessions of CRISP to participants after a suicide-related hospitalization

12 weeks

12 visits (in-person)

R61 Follow-up

Participants are assessed for target engagement with EEG assessments and cognitive reappraisal paradigm

12 weeks

Assessments at discharge, 6 and 12 weeks post-discharge

R33 Treatment

Participants are randomized to CRISP or Supportive Therapy to evaluate cognitive reappraisal and suicide risk

24 weeks

Assessments at admission, discharge, 6, 12, and 24 weeks post-discharge

R33 Follow-up

Participants are monitored for improvement in cognitive reappraisal ability and its association with suicide risk

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Reappraisal Intervention for Suicide Prevention
• Supportive Therapy

Trial Overview The study tests a new emotion-regulation intervention aimed at reducing suicide risk against supportive therapy. It targets middle-aged and older adults post-suicide-related hospitalization to see if the novel approach can better prevent future crises.

How Is the Trial Designed?

Group I: CRISP (R61) Experimental Treatment 1 Intervention

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.

Group II: CRISP (R33) Experimental Treatment 1 Intervention

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.

Group III: Supportive Therapy (ST) (R33) Active Control 1 Intervention

Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.

Cognitive Reappraisal Intervention for Suicide Prevention is already approved in United States for the following indications:

Approved in United States as CRISP for:

• Suicide prevention in middle-aged and older adults

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Published Research Related to This Trial

In a study of 120 individuals with recent suicide attempts, those receiving cognitive therapy showed a significantly faster improvement in their problem-solving skills, particularly in reducing negative views and impulsive behaviors, compared to a control group.

Cognitive therapy not only helps decrease the recurrence of suicide attempts but also leads to rapid changes in problem-solving appraisal within 6 months, which is crucial during the high-risk period following a suicide attempt.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in problem-solving appraisal after cognitive therapy for the prevention of suicide. Ghahramanlou-Holloway, M., Bhar, SS., Brown, GK., et al.[2022]

A manual-based cognitive-behavioral therapy for suicide prevention (CBT-SP) was developed and tested on 110 adolescents aged 13 to 19 who recently attempted suicide, focusing on risk reduction and relapse prevention.

The therapy was well-received, with 72.4% of participants completing 12 or more sessions, indicating its feasibility for preventing recurrence of suicidal behavior in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. Stanley, B., Brown, G., Brent, DA., et al.[2022]

The SAFETY program, a cognitive-behavioral and family-focused treatment, significantly reduced the likelihood of suicide attempts in adolescents aged 12-18 who had recently engaged in self-harm, with a 100% survival rate without attempts in the SAFETY group compared to 67% in the control group at the 3-month follow-up.

This study, involving a randomized controlled trial, is the second to show that combining cognitive-behavioral therapy with family involvement can effectively protect high-risk youths from suicide attempts, highlighting the importance of family support in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Family Treatment for Suicide Attempt Prevention: A Randomized Controlled Trial. Asarnow, JR., Hughes, JL., Babeva, KN., et al.[2023]

Outpatients with mood disorders who committed suicide attended significantly fewer cognitive therapy sessions and had a higher dropout rate (88% vs. 53%) compared to those who did not commit suicide, indicating that engagement in therapy is crucial.

Patients who committed suicide exhibited higher levels of hopelessness at the end of therapy, suggesting that inadequate response to treatment and premature termination are important risk factors for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadequate response to therapy as a predictor of suicide. Dahlsgaard, KK., Beck, AT., Brown, GK.[2007]

In a study of 232 inpatient patients at a German psychotherapeutic hospital, the emotion regulation strategy of 'expressive suppression' was found to significantly predict increased suicidal ideation, indicating a potential risk factor for suicidality.

The relationship between expressive suppression and suicidal thoughts was independent of the presence of a current depressive episode, suggesting that this emotion regulation strategy may have unique implications for therapeutic approaches in treating suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation of cognitive reappraisal and expressive suppression to suicidal ideation and suicidal desire. Forkmann, T., Scherer, A., Böcker, M., et al.[2015]

The study involved 147 patients who had previously attempted suicide, and after a 6-session cognitive-based psychotherapy intervention over four months, there was a notable reduction in the odds of further suicide attempts and an increase in outpatient visits, although these results were not statistically significant.

While the intervention did not significantly lower the risk of subsequent suicide attempts or clinical severity at the 12-month mark, it did improve treatment adherence among patients who had made multiple attempts, suggesting that targeted approaches may be beneficial for specific subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive-based Psychosocial Intervention and Case Management for Suicide Attempters Discharged from the Emergency Department in Taipei, Taiwan: A Randomized Controlled Study. Lin, YC., Liu, SI., Chen, SC., et al.[2021]

Cognitive reappraisal, a common emotion regulation strategy, can improve emotional states in controlled settings, but its effectiveness may be limited by individual differences and the context in which it is applied, highlighting the need for tailored approaches in clinical practice.

The mechanism of cognitive reappraisal resembles extinction learning, where new meanings are assigned to emotional stimuli, suggesting that environmental cues play a crucial role in helping clients develop and retain effective emotional regulation strategies in real-life situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new understanding of the cognitive reappraisal technique: an extension based on the schema theory. Wang, YX., Yin, B.[2023]

A brief, one-time dialectical behavior therapy skills-based intervention was found to be valuable and acceptable to both treatment-seeking and nontreatment-seeking individuals experiencing suicidal ideation.

At the 1-month follow-up, participants reported significantly lower levels of suicidal ideation and an increase in the use of the skills taught during the intervention, indicating its potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open pilot feasibility study of a brief dialectical behavior therapy skills-based intervention for suicidal individuals. Ward-Ciesielski, EF.[2022]

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a new psychosocial intervention designed specifically for middle-aged and older adults recently hospitalized for suicidal ideation or attempts, addressing the high suicide risk during the critical post-hospitalization period.

CRISP focuses on identifying personalized emotional triggers and using cognitive reappraisal techniques to help individuals manage negative emotions, potentially reducing suicidal thoughts and improving overall suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) for Middle-Aged and Older Adults Hospitalized for Suicidality. Kiosses, DN., Alexopoulos, GS., Hajcak, G., et al.[2022]

In a study of 33 undergraduate students, those with a history of suicidal ideation showed a heightened brain response (measured by the late positive potential, LPP) when trying to reduce negative emotions in response to distressing images, indicating a struggle with cognitive reappraisal.

These results suggest that difficulties in effectively using cognitive reappraisal to manage negative emotions may be associated with an increased risk of suicidal thoughts and behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in emotion modulation using cognitive reappraisal in individuals with and without suicidal ideation: An ERP study. Kudinova, AY., Owens, M., Burkhouse, KL., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5860974/

Cognitive Reappraisal Intervention for Suicide Prevention ... In this article, we present the main aspects, stages, techniques and a clinical case study of Cognitive Reappraisal Intervention for Suicide Prevention (CRISP), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03026127

A Novel Cognitive Reappraisal Intervention for Suicide Prevention The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in middle-aged and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748117305444

Cognitive Reappraisal Intervention for Suicide Prevention ... In this article, we present the main aspects, stages, techniques and a clinical case study of Cognitive Reappraisal Intervention for Suicide Prevention (CRISP), ...

4. grants.uberresearch.com grants.uberresearch.com/100000025/R61MH110542/A-Novel-Cognitive-Reappraisal-Intervention-for-Suicide-Prevention

A Novel Cognitive Reappraisal Intervention for Suicide ... ABSTRACT The goal of this project is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03026127/a-novel-cognitive-reappraisal-intervention-for-suicide-prevention

A Novel Cognitive Reappraisal Intervention for Suicide ... The goal of this trial is to refine and test a novel emotion-regulation based psychosocial intervention designed to reduce suicide risk in ...

6. researchgate.net researchgate.net/publication/322081524_Cognitive_Reappraisal_Intervention_for_Suicide_Prevention_CRISP_for_Middle-Aged_and_Older_Adults_Hospitalized_for_Suicidality

Cognitive Reappraisal Intervention for Suicide Prevention ... Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) targets emotion dysregulation and psychological distress for middle-aged and older adults at ...