Development of a Recovery Oriented Treatment for Post-Acute Suicidal Episode (PASE) Veterans

NCT04731519 | Recruiting

• 2 other identifiers: D3571-WRX-003571-01A1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Recovery Assessment Scale

  The RAS is a 41-item self-report measure using a 5-point Likert scale with outcome scores ranging from 1-5 and increasing scores indicating better outcomes. Sample items include: 'I have a desire to succeed.' and 'I have goals in life that I want to reach.' Factor analysis identified five factors: personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by symptoms (Salzer \& Brusilovskiy, 2014). Narrative reviews of recovery measures have been highly favorable toward the RAS which has been described as the most acceptable and valid measure of personal recovery available (Salzer \& Brusilovskiy, 2014)

  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

  a widely used semi-structured interview in VA clinical studies measuring suicide ideation and behavior has demonstrated sensitivity to change (Stanley \& Brown, 2008). The first subscale, (severity scale) is a 6-point ordinal scale, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). The second subscale, (intensity scale) is comprised of five items (i.e., frequency, duration, controllability, deterrents, reasons for ideation), rated on an ordinal scale (total scores ranging from 2 to 25). The behavior scale is a 5-point scale assessing interrupted, aborted, and actual suicide attempts; preparatory behavior for a suicide attempt; and non-suicidal self-injurious behavior.

  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

Secondary Outcomes (7)

• Change in WHOQOL-BREF

  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 Satisfaction With Life Scale

  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 Beck Hopelessness Scale

  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 WHODAS 2.0

  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 Future Self Continuity Questionnaire

  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

Study Arms (3)

General Health Education Active Control Group

ACTIVE COMPARATOR

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

Behavioral: General Health Education

CI-CT Group

EXPERIMENTAL

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.

Behavioral: Continuous Identity Cognitive Therapy (CI-CT)

CI-CT Treatment Development Group

OTHER

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.

Behavioral: Continuous Identity Cognitive Therapy (CI-CT)

Interventions

General Health Education BEHAVIORAL

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

General Health Education Active Control Group

Continuous Identity Cognitive Therapy (CI-CT) BEHAVIORAL

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.

CI-CT Group; CI-CT Treatment Development Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

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

RECRUITING

Related Publications (1)

• Sokol Y, Glatt S, Andrusier S, Levin C, Boucher C, Ridley J, Brown CH, Landa Y, Glynn S, Goodman M. Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study. Contemp Clin Trials Commun. 2025 Nov 24;48:101576. doi: 10.1016/j.conctc.2025.101576. eCollection 2025 Dec.

  PMID: 41403475 DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Yosef A Sokol, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yosef A Sokol, PhD

CONTACT

(718) 584-9000; Yosef.Sokol@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two stage model including a open label single group for treatment development purposes and, following this, an experimental and control group.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: February 1, 2021
• Study Start: February 22, 2022
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): March 17, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)