Social Reward Psychotherapy for Suicidal Thoughts

Overseen By Nili Solomonov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Must be taking: Antidepressants

Must not be taking: Psychotropic drugs

Disqualifiers: Neurological disorders, Severe medical illness, others

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

Compensation: Varies

Number of Visits: 9

Duration: 9 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new therapy called Engage & Connect Psychotherapy, designed to reduce suicidal thoughts by enhancing positive social interactions. Participants will either engage in this therapy or receive symptom education, both targeting depression. It is ideal for individuals aged 50-80 who experience depression and occasional suicidal thoughts but have no immediate plans to act on them. The trial seeks participants who are either not taking antidepressants or are on a stable dose. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve mental health treatments.

Will I have to stop taking my current medications?

The trial requires that you either be off antidepressants or on a stable dose for 8 weeks, and you should not plan to change the dose during the study. Other psychotropic drugs are generally not allowed, except for a small dose of lorazepam.

What prior data suggests that these psychotherapies are safe?

Research has shown that Engage & Connect psychotherapy is generally safe for participants. In one study, individuals at risk for suicide collaborated with therapists to develop action plans and coping strategies, which helped them manage symptoms without serious side effects.

Another study examined postpartum depression and found similar results. Participants reported feeling more socially connected and less depressed, again without significant negative effects. These findings suggest that the therapy is well-tolerated and may benefit those dealing with suicidal thoughts or depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Engage & Connect Psychotherapy because it takes a fresh approach to reducing suicidal thoughts by focusing on social engagement, rather than just managing symptoms through medication or traditional talk therapy. Unlike many existing treatments that primarily address the chemical imbalances in the brain, this therapy works by encouraging individuals to actively participate in rewarding social activities, which can enhance their sense of connection and purpose. Delivered remotely, it offers flexibility and accessibility, making it easier for middle-aged and older adults to participate without the need for frequent clinic visits. This novel focus on social rewards might offer a new pathway to alleviating symptoms of depression and reducing suicidality.

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

Research shows that Engage & Connect therapy, a treatment in this trial, can reduce depression by encouraging participation in enjoyable social activities. Studies have found that engaging in these activities helps people feel less isolated and improves overall mood. For individuals at risk of suicide, this therapy emphasizes planning social activities, which has been linked to reducing suicidal thoughts and actions. Early findings suggest that increased social connection often decreases feelings of loneliness and depression. This makes Engage & Connect a promising method for reducing suicidal thoughts in middle-aged and older adults. ^{1 4 6 7 8}

Who Is on the Research Team?

Nili Solomonov, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 with Major Depressive Disorder and suicidal thoughts, who have a certain level of cognitive function (MMSE score within normal range) and are either off antidepressants or on a stable dose. They must not be receiving other psychotherapy, have no plans to change medication doses, and cannot have severe medical conditions or other psychiatric diagnoses that could interfere with the study.

Inclusion Criteria

I've been on a stable dose of antidepressants for 8 weeks and won't change it.

I am able to understand and agree to the research and treatment plan.

I have been diagnosed with Major Depressive Disorder.

Exclusion Criteria

I have a neurological disorder like dementia or Parkinson's.

Intent or plan to attempt suicide in the near future

I take 0.5 mg or less of lorazepam daily, but no other psychotropic drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to 9-weekly sessions of either Engage & Connect therapy or Symptom Review and Psychoeducation

9 weeks

9 visits (virtual)

Assessment

Participants complete 4 research assessments and 3 MRI scans to evaluate brain- and behavioral changes

9 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Engage & Connect Psychotherapy
• Symptom Review and Psychoeducation (SRP)

Trial Overview

'Engage & Connect' Psychotherapy is being tested against Symptom Review and Psychoeducation (SRP) over a 9-week period to see if it improves brain functions related to positive emotions and reduces suicidality in older adults suffering from depression.

How Is the Trial Designed?

Group I: "Engage & Connect" Psychotherapy Experimental Treatment 1 Intervention

Engage \& Connect is a remotely-delivered psychotherapy, aimed to increase engagement in rewarding social activities and in turn, reduce suicidality. In Engage \& Connect, depressed middle-aged and older adults with suicidal ideation work with a therapist to develop "action plans" to pursue rewarding social activities of their choice.

Group II: Symptom Review and Psychoeducation (SRP) Active Control 1 Intervention

In this intervention, the therapist will review the participant's symptoms and provide literature-based clinical explanations and clarifications about the symptoms, the course, and the causes of depression and aging processes. In SRP, the therapist reviews the depressed individual's symptoms, and level of information on depression, identifies misconceptions, and guides selection of educational material which could benefit the patient.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 98 young adults who had recently attempted or thought about suicide, those with poorer problem-solving skills showed greater improvement when receiving problem-solving treatment compared to those with better skills, indicating that targeting deficits can be more effective.

The findings suggest that for individuals struggling with suicidal thoughts, focusing on improving problem-solving abilities rather than leveraging existing strengths may lead to better treatment outcomes over a 6-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of compensation and capitalization models when treating suicidality in young adults. Wingate, LR., Van Orden, KA., Joiner, TE., et al.[2009]

This study aims to evaluate a blended problem-solving therapy for men at risk of suicide, combining face-to-face therapy with a smartphone app, to improve outcomes for those who have engaged in self-harm.

The primary focus is on reducing suicidal ideation, with secondary measures assessing depression, anxiety, PTSD, and overall quality of life, using a cohort study design nested within a larger trial to explore the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BEACON study: protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario. Hatcher, S., Heisel, M., Ayonrinde, O., et al.[2023]

Cognitive behavior therapy (CBT) and problem-solving therapy (PST) both led to significant improvements in various measures related to hopelessness and suicidal ideation among suicide attempters, indicating their efficacy as treatment options.

Participants receiving CBT and PST reported higher satisfaction levels compared to those receiving treatment as usual (TAU), highlighting the potential benefits of these brief therapies in managing suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing cognitive behavior therapy, problem solving therapy, and treatment as usual in a high risk population. Stewart, CD., Quinn, A., Plever, S., et al.[2018]

This study aims to systematically review and analyze the effectiveness of psychotherapy in reducing suicidal thoughts and behaviors by conducting an individual patient data meta-analysis (IPD-MA) involving adult outpatients with suicidal ideation or behavior.

The research will identify factors that may moderate the efficacy of psychotherapy, providing valuable insights for mental health practitioners to tailor treatments for individuals at risk of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive database and individual patient data meta-analysis of randomised controlled trials on psychotherapies reducing suicidal thoughts and behaviour: study protocol. Hu, MX., Palantza, C., Setkowski, K., et al.[2021]

Cognitive behavioral therapy (CBT) and dialectical behavioral therapy (DBT) have been identified as effective psychotherapeutic treatments for individuals who have attempted suicide, based on recent Cochrane reviews and meta-analyses.

Despite the effectiveness of these therapies, the overall impact is small, and there are significant methodological issues in the research, indicating a need for better empirical support and wider dissemination of suicide-specific psychotherapy programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychotherapy after a suicide attempt-current evidence and evaluation]. Teismann, T., Gysin-Maillart, A.[2022]

Telehealth problem-solving therapy (tele-PST) significantly reduced suicidal ideation among low-income homebound adults aged 50+, showing an effect size of 0.31 at 36 weeks, compared to a support call.

In-person PST also reduced hopelessness and suicidal ideation, but the effect was not as strong as tele-PST, indicating that telehealth may be a more effective option for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Problem-Solving Therapy on Depressed Low-Income Homebound Older Adults' Death/Suicidal Ideation and Hopelessness. Choi, NG., Marti, CN., Conwell, Y.[2022]

The PREVAIL peer support intervention, designed for psychiatric inpatients at high risk for suicide, was found to be feasible and acceptable, with participants attending an average of 6.1 sessions over 12 weeks.

Qualitative feedback from participants indicated that peer specialists effectively provided support and fostered discussions about hope and safety, highlighting the potential of peer support in suicide prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and pilot study of a suicide prevention intervention delivered by peer support specialists. Pfeiffer, PN., King, C., Ilgen, M., et al.[2022]

Psychotherapeutic interventions have been shown to effectively reduce suicidal thoughts and behaviors, as evidenced by several randomized controlled trials (RCTs) that demonstrate their efficacy in preventing suicide attempts.

Despite these positive findings, the current literature has significant gaps and methodological limitations, indicating a need for more rigorous research to enhance the effectiveness of suicide prevention therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based psychotherapies for suicide prevention: future directions. Brown, GK., Jager-Hyman, S.[2022]

Individuals who attempt suicide often do not continue with treatment, indicating a significant challenge in engaging them in ongoing care.

Current evidence on the effectiveness of psychosocial interventions in reducing repeated suicidal behaviors is inconclusive, suggesting that while some groups may benefit, more research is needed to improve treatment delivery and follow-through.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide and suicidal behaviours: implications for mental health services. Rhodes, AE., Links, PS.[2017]

The study identified five effective manualized treatments for reducing suicidality, highlighting common interventions such as a clear treatment framework, crisis management strategies, and an active therapist style, based on a comprehensive review of literature from 1970 to 2007.

While the treatments shared several key elements, the study emphasizes the need for further research to determine which specific interventions or combinations are most effective in reducing suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies in treatment of suicidality: identification of common and treatment-specific interventions in empirically supported treatment manuals. Weinberg, I., Ronningstam, E., Goldblatt, MJ., et al.[2022]

Building a strong therapeutic alliance with suicidal patients is crucial for effective treatment, emphasizing shared responsibility for patient safety.

Three key principles—fostering a treatment alliance, exploring the reasons behind suicidal thoughts, and encouraging emotional expression—are supported by evidence from trials, highlighting their importance in reducing feelings of isolation and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core principles in treating suicidal patients. Fowler, JC.[2022]

Current suicide risk models primarily focus on psychiatric disorders, but they fail to address the personal and fluid nature of an individual's experience with suicidality, highlighting the need for more patient-centered approaches.

Effective therapeutic interventions for reducing suicide risk should emphasize collaboration between therapist and patient, focusing on active participation and understanding the individual's unique crisis, while also considering the integration of biological factors into psychological treatment models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide Models and Treatment Models Are Separate Entities. What Does It Mean for Clinical Suicide Prevention? Michel, K.[2022]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

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