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IOK Therapy for PTSD (IOK Trial)

N/A
Waitlist Available
Led By Shira Maguen, 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
If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from post-treatment (week 10) to 6 month follow-up
Awards & highlights

IOK Trial Summary

This trial is testing whether a new treatment called Impact of Killing (IOK) is more effective than present-centered therapy (PCT) for treating post-traumatic stress disorder (PTSD) in veterans.

Who is the study for?
This trial is for Veterans aged 18-82 with PTSD related to moral injury from killing in war. They must have completed or be stable on PTSD treatments like CPT or PE, and not changing medications during the study. Those with recent severe mental health issues, substance dependence, or active suicidal behaviors cannot join.Check my eligibility
What is being tested?
The trial tests a new treatment called Impact of Killing (IOK) against Present Centered Therapy (PCT). It aims to see if IOK improves psychosocial functioning and reduces PTSD symptoms more effectively than PCT, and whether these improvements last at least six months after treatment.See study design
What are the potential side effects?
While specific side effects are not listed for IOK or PCT, psychological interventions can sometimes cause temporary increases in distress as individuals confront traumatic memories or challenging emotions during therapy.

IOK Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a Veteran and have completed my CPT or PE treatment, waiting for two weeks before screening.
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I am a veteran who has started or finished PTSD treatment like CPT or PE.
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I am a veteran aged between 18 and 82.
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I have been on stable PTSD medication for at least a month and won't change it during the study.

IOK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from post-treatment (week 10) to 6 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from post-treatment (week 10) to 6 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
World Health Organization Quality of Life-BREF
Secondary outcome measures
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Other outcome measures
Quality of Life Inventory (QOLI)
Trauma-related Guilt Inventory (TRGI)

IOK Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Impact of Killing (IOK)Experimental Treatment1 Intervention
Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
Group II: Present Centered TherapyActive Control1 Intervention
Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,495 Total Patients Enrolled
5 Trials studying Moral Injury
367 Patients Enrolled for Moral Injury
Shira Maguen, PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
4 Previous Clinical Trials
230 Total Patients Enrolled

Media Library

Moral Injury Clinical Trial 2023: Impact of Killing (IOK) Highlights & Side Effects. Trial Name: NCT03764033 — N/A
Impact of Killing (IOK) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03764033 — N/A

Frequently Asked Questions

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

Are there still opportunities for volunteers to partake in this research?

"Affirmative. As per the information on clinicaltrials.gov, this research trial is actively looking for participants to take part in it; the study was first posted on August 12th 2019 and last updated July 1st 2022. It requires 95 individuals from 2 medical centres to be enrolled."

Answered by AI

Is the enrollment criteria for this trial limited to individuals aged fifty and below?

"Per the inclusion criteria, participants in this trial must be between 18 and 82 years of age."

Answered by AI

Is enrollment available for this research study?

"This research trial is recruiting 95 veterans suffering from moral injury, aged 18 to 82. Qualifying criteria includes having experienced killing or death in a warzone with continued distress; DSM-5 PTSD diagnosis or CAPS score of 23+; positive response to at least one item on the EMIS-M scale or MIES #4; completion and two weeks waiting period after CPT/PE treatment if undergoing therapy; 1 month stability on prescription medications for PTSD without any changes during active phase of study and initiation/completion of evidence based treatments such as CPT/PE."

Answered by AI

What is the current participant headcount of this clinical research?

"Affirmative, clinicaltrials.gov indicates that this trial is still on-going and actively seeking participants since it was posted in August 12th 2019 with the latest update occurring July 1st 2022. The project necessitates 95 patients to be recruited from two distinct locales."

Answered by AI
~2 spots leftby Apr 2024