IOK Therapy for PTSD

(IOK Trial)

Recruiting at 2 trial locations

Overseen By Shira Maguen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorder, Untreated mania, Recent hospitalization, Alcohol dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

101 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.

Research Team

Shira Maguen, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

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.

Inclusion Criteria

I am a Veteran and have completed my CPT or PE treatment, waiting for two weeks before screening.

I am a veteran who has started or finished PTSD treatment like CPT or PE.

Veterans who have experienced and feel upset or disturbed about causing harm or being involved in the death of others in a war zone.

Exclusion Criteria

Veterans with recent psychiatric hospitalizations

If you have recently had thoughts of hurting yourself or others, you may not be able to participate. But if you often think about hurting yourself, that's okay.

Veterans with current or lifetime diagnosis of a psychotic disorder or current untreated/unmanaged mania

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Impact of Killing (IOK) or Present Centered Therapy (PCT) for 10 sessions, each lasting 60-90 minutes

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for psychosocial functioning and PTSD severity, with assessments at 6 months post-treatment

6 months

Treatment Details

Interventions

• Impact of Killing (IOK)
• Present Centered Therapy

Trial Overview 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.

Participant Groups

Group I: Impact of Killing (IOK) Experimental Treatment 1 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 Therapy Active Control 1 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)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+