Recruiting

Recovery Oriented Treatment

Sponsor:

VA Office of Research and Development

Code:

NCT04731519

Conditions

Suicide

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous Identity Cognitive Therapy (CI-CT)

General Health Education

Study Details

Brief summary:

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.

Conditions

Suicide

Study ID

NCT04731519

Start date

Feb 22, 2022

Status verified date

Mar, 2026

Completion date

Mar 17, 2027

Anticipated

Primary completion date

Sep 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • suicide attempt, or creation of a suicide plan with intent or preparatory behavior, within the past year, as assessed using the Columbia Suicide Severity Rating Scale (CSSRS) - to provide this information, in addition to the standard lifetime/3 months categories in the CSSRS a 1 year category will be added
  • participation in mental health services at the JJPVA
  • sufficient clinical stability and readiness to participate in a group therapy as deemed by a mental health treatment provider
  • sufficient medical stability as deemed by a medical provider
  • Veteran of US Military
  • resides in NYC region

Exclusion Criteria:

  • active alcohol or opiate dependence requiring medically supervised withdrawal
  • imminent risk of suicidal or homicidal behavior
  • acute suicidal episode within past week
  • current acute suicidal symptoms (based on scores of the BSI and SBQ-R - see above)
  • inability to perform CI-CT treatment tasks based on their performance on a sample reading and writing task from the CI-CT manual (given during screening), operationalized as an ability to read the sample material, understand the instructions, and write a response connected with the material and in line with the writing instructions
  • unable to speak English
  • lack of capacity to consent
  • unable or unwilling to provide at least one contact for emergency purposes
  • unable to attend outpatient group treatment program
  • participation in another intervention RCT
  • insufficient interpersonal functioning to function appropriately within the group assessed through a consultation with the referrer and the Veterans' mental health provider about their interpersonal functioning and ability to tolerate group therapy, and a chart review searching for disruptive behavior in group therapy

Study Design

Enrollment

57 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: General Health Education Active Control Group

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

experimental: CI-CT Group

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.

other: CI-CT Treatment Development Group

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.

Interventions

Continuous Identity Cognitive Therapy (CI-CT)

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 recovery oriented CI-CT for post acute suicidal episode Veterans 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.

General Health Education

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

Primary outcome measure

  • Change in Recovery Assessment Scale [ Time Frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention ]
  • Change in Columbia Suicide Severity Rating Scale [ Time Frame: four assessment time points: (TP-1) baseline, (TP-2) immediately following intervention, (TP-3) follow-up at 3 months post-intervention and (TP-4) 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

James J. Peters VA Medical Center, Bronx, NY

Recruiting

The Bronx, New York, United States, 10468-3904

Contacts

Principal Investigator:

Yosef A Sokol, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Keywords

  • Personal Identity
  • Recovery
  • Future Self-Continuity
  • Post-Acute Suicidal Episode
  • Continuous Identity
  • Suicide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-13.