Recovery Oriented Cognitive Therapy for Suicide Risk

Recruiting at 1 trial location

Overseen By Marianne S Goodman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Alcohol, Opiate dependence, Suicidal risk, others

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

Compensation: Varies

Number of Visits: 28

57 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and test a new therapy called Continuous Identity Cognitive Therapy (CI-CT) to support Veterans who have experienced suicidal thoughts or actions. The goal is to help these Veterans build a positive sense of self and future through structured group sessions. Participants will be divided into groups, with some receiving the new CI-CT therapy and others participating in general health education sessions for comparison. Veterans who have attempted suicide or had a serious plan in the past year and are currently receiving mental health services in NYC might be a good fit for this trial. As an unphased study, this trial offers Veterans a unique opportunity to contribute to the development of innovative mental health therapies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research has shown that Continuous Identity Cognitive Therapy (CI-CT) is practical and well-received by Veterans who have experienced suicidal thoughts. Studies indicate that Veterans find this therapy helpful and are generally open to participating. CI-CT aims to boost hope, reduce depression, and address suicidal thoughts.

Although this therapy is still fairly new, early feedback suggests it is well-tolerated. Veterans report positive experiences, and significant negative effects have not been reported. This therapy includes group sessions that focus on personal growth and planning for the future, which participants seem to appreciate. However, like any new treatment, ongoing research will help confirm its safety and effectiveness over time. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Continuous Identity Cognitive Therapy (CI-CT) because it offers a fresh approach to reducing suicide risk by integrating cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) with unique components. Unlike traditional therapies that often focus on immediate symptom relief, CI-CT emphasizes building a continuous identity and a future-oriented life story, helping individuals connect with their desired future selves. This therapy aims to increase hopefulness, life meaning, and empowerment by constructing a personal narrative and identifying life values, which are new ways of engaging patients compared to standard therapies.

What evidence suggests that this trial's treatments could be effective for Veterans with suicidal symptoms?

Research has shown that Continuous Identity Cognitive Therapy (CI-CT), one of the treatments studied in this trial, may assist Veterans who have experienced a Post-Acute Suicidal Episode (PASE). CI-CT aims to enhance how Veterans perceive their life story and future, potentially increasing feelings of hope and purpose. Early studies suggest that CI-CT is practical and well-received by Veterans, indicating they are likely to participate and benefit from it. By integrating elements of Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT), CI-CT helps Veterans connect with their future selves and pursue personal goals. Although further research is necessary, these early findings suggest that CI-CT could be a valuable tool for supporting Veterans' mental health recovery. Another group in this trial will receive General Health Education, serving as an active control condition. ^{1 3 4 6 7}

Who Is on the Research Team?

Yosef A Sokol, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Are You a Good Fit for This Trial?

This trial is for U.S. Military Veterans in the NYC region who've had a suicide attempt or plan within the past year but are currently stable enough to join group therapy. They must be involved in mental health services and medically stable, with no acute suicidal symptoms or imminent risk behaviors.

Inclusion Criteria

Resides in NYC region

Participation in mental health services at the JJPVA

Sufficient medical stability as deemed by a medical provider

Exclusion Criteria

I am unable to understand or make decisions about my treatment.

I cannot attend group treatment sessions in person.

Unable or unwilling to provide at least one contact for emergency purposes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Development

Three one-arm treatment development trials of CI-CT to test and improve the therapy protocol

12 weeks

12 weekly sessions (in-person)

Pilot RCT

Pilot RCT to assess the acceptability and feasibility of CI-CT for PASE Veterans

12 weeks

12 weekly sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at 3 and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Identity Cognitive Therapy (CI-CT)
• General Health Education

Trial Overview The study tests Continuous Identity Cognitive Therapy (CI-CT), aimed at improving Veterans' life story and future outlook, against General Health Education. It seeks to fill gaps in care post-suicide attempts by focusing on recovery-oriented psychotherapy.

How Is the Trial Designed?

Group I: CI-CT Treatment Development Group Experimental Treatment 1 Intervention

The 3 treatment development groups will receive CI-CT (Continuous Identity Cognitive Therapy). CI-CT is planned to be a weekly, 90-minute, 12-session group treatment and to be run by two clinicians using the final version manual and workbook. CI-CT was developed as a manualized treatment integrating components of CBT and Acceptance and Commitment Therapy (ACT) with self-continuity and future-self related interventions to help Veterans develop a better present-to-the-future life story as a framework for increasing hopefulness, a sense of life meaning, empowerment, and an ability to attain future self-goals. The CI-CT includes eight components: 1) constructing a CI narrative, 2) mindfulness training, 3) life values identification, 4) developing a self-growth perspective, 5) identifying possible future selves - timelines, 6) connecting with the desired future self, 7) CI as context for current problems, and 8) moving toward the future self.

Group II: CI-CT Group Experimental Treatment 1 Intervention

The experimental group will receive CI-CT (Continuous Identity Cognitive Therapy). CI-CT is planned to be a weekly, 90-minute, 12-session group treatment and to be run by two clinicians using the final version manual and workbook. CI-CT was developed as a manualized treatment integrating components of CBT and Acceptance and Commitment Therapy (ACT) with self-continuity and future-self related interventions to help Veterans develop a better present-to-the-future life story as a framework for increasing hopefulness, a sense of life meaning, empowerment, and an ability to attain future self-goals. The CI-CT includes eight components: 1) constructing a CI narrative, 2) mindfulness training, 3) life values identification, 4) developing a self-growth perspective, 5) identifying possible future selves - timelines, 6) connecting with the desired future self, 7) CI as context for current problems, and 8) moving toward the future self.

Group III: General Health Education Active Control Group Active Control 1 Intervention

The control condition will receive General Health Education a structured manualized group health education intervention previously developed by VISN 2 MIRECC investigators as a control condition for group psychotherapy RCTs. It has 12 1.5-hour weekly group sessions focusing on health and wellness topics such as Sleep, Physical Activity, Impact of Stress, Relaxation Techniques, Substance Use, Nutrition, Managing Daily Activities, Medication Benefits and Side Effects. GHE was chosen for the AC because it aligns in many respects with CI-CT (e.g., group format, length of sessions, similar expectations) while diverging in specific topics and skills targeted allowing for control of common factors like attention without causing confounding due to overlap in concepts

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Continuous identity cognitive therapy (CI-CT) is a new intervention designed to help individuals struggling with suicidal thoughts by focusing on their perceived future self and personal goals, integrating techniques from cognitive behavioral therapy and acceptance and commitment therapy.

In a pilot study with 17 U.S. Veterans, CI-CT was found to be feasible and acceptable, showing potential benefits in reducing suicidality, depression, and hopelessness, with improvements in future self-continuity maintained at a 1-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Identity Cognitive Therapy: Feasibility and Acceptability of a Novel Intervention for Suicidal Symptoms. Sokol, Y., Ridley, J., Goodman, M., et al.[2021]

A case report demonstrated that a patient with PTSD and major depression achieved complete recovery after undergoing six sessions of self-study assisted cognitive therapy, which reduced therapist contact time by half compared to standard treatment.

This approach suggests that self-study modules can be a feasible and effective way to treat PTSD, but further research is needed to evaluate its broader acceptability and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-study assisted cognitive therapy for PTSD: a case study. Wild, J., Ehlers, A.[2021]

Cognitive-behavioral therapy (CBT) has become the most supported psychological treatment for various psychiatric conditions, including many Axis I and selected Axis II disorders, due to its evolution over four decades based on empirical evidence.

The development of CBT has followed a scientific framework that includes systematic observations, operational definitions of cognitive and behavioral constructs, and large-scale randomized controlled trials, ensuring its efficacy and adaptability in treating mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy: empirical considerations. Rector, NA.[2013]

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]

Cognitive therapy (CT) has evolved into a broad scientific approach that includes various disorder-specific interventions, making it adaptable for different psychological disorders.

The article reviews the efficacy and validity of CT, highlighting its effectiveness in treating conditions like posttraumatic stress disorder and health anxiety, while also noting the differences and similarities in treatment approaches for these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The science of cognitive therapy. Hofmann, SG., Asmundson, GJ., Beck, AT.[2018]

Cognitive therapy effectively addresses key issues in suicidal patients, such as perfectionism, social sensitivity, and hopelessness, by helping them develop constructive thinking patterns.

The therapy involves planning activities and tracking negative thoughts, which can lead to a decrease in feelings of hopelessness and improve overall mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive therapy for the suicidal patient: a case study. Reilly, CE.[2019]

An interdisciplinary, recovery-oriented intensive outpatient program (IR-IOP) for veterans showed a significant decrease in suicide ideation severity after treatment, indicating its potential effectiveness in suicide prevention.

The program utilized evidence-based strategies and assessed outcomes using standardized measures, although it lacked a control group and follow-up data, which limits the strength of the conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Recovery-Oriented Intensive Outpatient Program for Veterans at Risk for Suicide. Roush, JF., O'Brien, KM., Ruha, AL.[2021]

The study is a 3-year pilot project involving 57 Veterans who have experienced an acute suicidal episode, aiming to assess the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT) for those in the post-acute suicidal episode (PASE) stage.

If CI-CT proves feasible and acceptable, it could lead to a larger randomized controlled trial to evaluate its effectiveness in reducing suicidal thoughts and behaviors, ultimately helping to improve recovery outcomes for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of continuous identity cognitive therapy as a recovery-oriented suicide treatment for Veterans: A study protocol. Sokol, Y., Andrusier, S., Glatt, S., et al.[2023]

Cognitive therapy (CT) is significantly more effective than waiting-list controls and antidepressants for treating mild to moderate depression, based on a meta-analysis of 48 high-quality trials involving 2765 patients.

CT may also help prevent relapses in the long term, suggesting it could be a more sustainable treatment option compared to antidepressants, which have higher relapse rates in naturalistic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effects of cognitive therapy in depressed patients. Gloaguen, V., Cottraux, J., Cucherat, M., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2451865423001394

Feasibility and acceptability of continuous identity cognitive ... This study aims to develop and evaluate the feasibility and acceptability of a novel recovery-oriented intervention for Veterans experiencing PASE.

2. researchgate.net researchgate.net/publication/348226771_Continuous_Identity_Cognitive_Therapy_Feasibility_and_Acceptability_of_a_Novel_Intervention_for_Suicidal_Symptoms

Continuous Identity Cognitive Therapy: Feasibility and ... We introduce continuous identity cognitive therapy (CI-CT), a novel suicide intervention. CI-CT was developed based on evidence that ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37546228/

Feasibility and acceptability of continuous identity cognitive ... This study aims to develop and evaluate the feasibility and acceptability of a novel recovery-oriented intervention for Veterans experiencing PASE.

4. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01523-2

A cognitive-behavioral treatment for suicide prevention among ... This randomized pilot trial will provide clinically relevant information about whether CBSPp can improve SI/A, depression, and psychosis among adults with SSDs.

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2823589

Brief Cognitive Behavioral Therapy for Suicidal Inpatients This randomized clinical trial assesses the effect of brief cognitive behavioral therapy on outcomes among suicidal inpatients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33397785/

Continuous Identity Cognitive Therapy: Feasibility and ... CI-CT is feasible, acceptable to Veterans, and may help with suicidality, depression, hopelessness, and future self-continuity.

7. zerosuicide.edc.org zerosuicide.edc.org/about/framework

Framework | Zero Suicide The seven elements of Zero Suicide represent what experts in the field of suicide prevention have identified as the core components of safe care.