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Recovery Oriented Cognitive Therapy for Suicide Risk

N/A

Recruiting

Led By Yosef A Sokol, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

Study Summary

This trial will assess and enhance a continuous identity-cognitive therapy (CI-CT) treatment for post-acute suicidal episode (PASE) veterans.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves psychotherapy interventions rather than medications, traditional side effects are not expected; however, participants may experience emotional discomfort when discussing sensitive topics related to their mental health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Columbia Suicide Severity Rating Scale

Change in Recovery Assessment Scale

Secondary outcome measures

Change in Beck Hopelessness Scale

Change in Future Self Continuity Questionnaire

Change in Interpersonal Needs Questionnaire

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: CI-CT Treatment Development GroupExperimental Treatment1 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 GroupExperimental Treatment1 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 GroupActive Control1 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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,127 Total Patients Enrolled

39 Trials studying Suicide

6,489 Patients Enrolled for Suicide

Yosef A Sokol, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

Media Library

Continuous Identity Cognitive Therapy (CI-CT) Clinical Trial Eligibility Overview. Trial Name: NCT04731519 — N/A

Suicide Research Study Groups: General Health Education Active Control Group, CI-CT Group, CI-CT Treatment Development Group

Suicide Clinical Trial 2023: Continuous Identity Cognitive Therapy (CI-CT) Highlights & Side Effects. Trial Name: NCT04731519 — N/A

Continuous Identity Cognitive Therapy (CI-CT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731519 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have enrolled in the experiment thus far?

"Indeed, the records maintained on clinicaltrials.gov demonstrate that this experiment is actively searching for candidates to partake in the trial which was posted online on February 22nd 2022. Last updated April 1st 2022, 57 individuals are sought from a single site."

Answered by AI

What purpose does this clinical experiment seek to fulfill?

"The primary objective of this medical trial, with four assessment periods including baseline (TP-1), immediate post-intervention (TP-2), three months after the intervention (TP-3) and six months following treatment (TP4). is to measure changes in Columbia Suicide Severity Rating Scale. Secondary outcomes include alteration in Satisfaction With Life Scale, Interpersonal Needs Questionnaire and WHOQOL-BREF; all of which have been validated by past studies for their reliability, validity and correlation with measures of recovery. Scores range from 5 - 35 or 1 - 7 or 0 – 100 respectively depending on the scale being used."

Answered by AI

Are recruitment efforts currently underway for this trial?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this trial is actively trying to find volunteers. It was initially posted on February 22nd 2022 and has been modified recently on April 1st 2022, with the aim of enrolling 57 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Development of a Recovery Oriented Treatment for Post-Acute Suicidal Episode (PASE) Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04731519.