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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

Be older than 18 years old

Must not have

Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from post-treatment (week 10) to 6 month follow-up

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently in, nor planning to start, therapy for PTSD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from post-treatment (week 10) to 6 month follow-up

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

World Health Organization Quality of Life-BREF

Secondary study objectives

Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

Other study objectives

Quality of Life Inventory (QOLI)

Trauma-related Guilt Inventory (TRGI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 1Eligibility criteria met