Recovery Oriented Cognitive Therapy for Suicide Risk

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

Trial Summary

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.

What data supports the effectiveness of the treatment Continuous Identity Cognitive Therapy (CI-CT) for suicide risk?

Research shows that Continuous Identity Cognitive Therapy (CI-CT) is feasible and acceptable for Veterans with serious mental illness, and it may help reduce suicidality, depression, and hopelessness by improving the connection to a positive future self. This therapy combines elements of cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT), which are both well-supported for treating various mental health conditions. ^{1 2 3 4 5}

Is Recovery Oriented Cognitive Therapy for Suicide Risk safe for humans?

Continuous Identity Cognitive Therapy (CI-CT), a form of Recovery Oriented Cognitive Therapy, has been found to be feasible and acceptable in a small study with U.S. Veterans, with high retention rates and positive feedback, suggesting it is generally safe for humans. ^{1 5 6 7 8}

How is Continuous Identity Cognitive Therapy (CI-CT) different from other treatments for suicide risk?

CI-CT is unique because it combines elements of cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT) to help individuals create a meaningful life story with a positive future self, addressing the difficulty suicidal individuals have in seeing a connection to their future. This focus on future self-continuity and personal goals sets it apart from other treatments. ^{1 2 3 5 9}

What is the purpose of this trial?

Mental health care for Veterans with suicidal symptoms is of paramount import to the VA. Unfortunately, VA suicide reports show suicide rates increasing, suggesting a need for enhancing current VA suicide mental health care efforts. While several psychotherapeutic treatments exist for acute suicidality, there are few treatments designed to help Veterans following an acute suicidal episode (Post-Acute Suicidal Episode; PASE), particularly after acute risk declines but when they still have ongoing mental health needs and, at times, long-term suicidal symptoms. Available suicide treatments are not designed to promote the recovery and rehabilitation of PASE Veterans. This is a significant gap in comprehensive suicide-focused mental health care. One avenue to close this gap lies through the development of a recovery-focused psychotherapy for PASE Veterans. Developing recovery-oriented care, "a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential" is a VA priority; however, available treatments for suicidal Veterans do not place a strong focus on recovery. Decades of research have shown the importance of increasing Veterans hopefulness about the future, developing a positive self-identity, promoting Veterans' sense of self-empowerment and improving relationships. Continuous Identity-Cognitive Therapy (CI-CT) is a promising new manualized suicide intervention focused on improving Veterans sense of their life story and personal future, with goals similar to recovery-oriented care. The proposed study will assess and enhance the CI-CT treatment materials using Veteran feedback and acceptability and feasibility data. Then, with the guidance of scientific and Veteran consumer advisory boards, use these results to update the treatment. Findings will be used to make an updated adaptation of the treatment materials and to develop a research protocol for a pilot RCT of CI-CT for PASE Veterans. This study will develop and pilot test a well-specified, group-based intervention tailored to the unique needs of PASE Veterans. The results of the proposed study will provide data to 1) identify adaptations needed to optimize CI-CT for PASE Veterans: 2) identify possible benefits of CI-CT; 3) inform development of a pilot RCT of CI-CT for PASE Veterans.

Research Team

Yosef A Sokol, PhD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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-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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of continuous identity cognitive therapy as a recovery-oriented suicide treatment for Veterans: A study protocol. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Changes in problem-solving appraisal after cognitive therapy for the prevention of suicide. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy: empirical considerations. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Continuous Identity Cognitive Therapy: Feasibility and Acceptability of a Novel Intervention for Suicidal Symptoms. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A meta-analysis of the effects of cognitive therapy in depressed patients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The science of cognitive therapy. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Self-study assisted cognitive therapy for PTSD: a case study. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Evaluating a Recovery-Oriented Intensive Outpatient Program for Veterans at Risk for Suicide. [2021]