IOK Therapy for PTSD

(IOK Trial)

No longer recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for Veterans with PTSD, particularly those experiencing moral injury from involvement in wartime killing. The study compares a therapy called Impact of Killing (IOK), which targets moral injury, with a more general therapy addressing the overall impact of trauma. It seeks to determine if IOK can enhance daily life and reduce PTSD symptoms for Veterans, and if these improvements persist over time. Veterans who have experienced distress from actions in a war zone and have previously tried other PTSD treatments might be well-suited for this trial. As an unphased trial, it offers Veterans a unique opportunity to explore new therapeutic options tailored to their specific experiences.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but you must be stable on your PTSD medication for one month and not change it during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Impact of Killing (IOK) treatment is generally well-tolerated by participants. In a previous study, individuals who received IOK experienced significant improvements in PTSD symptoms and overall mental health. These studies reported no major safety concerns, and most participants completed the treatment. Only two individuals, one from each group, did not finish the treatment. This suggests that the treatment is manageable for most participants. Overall, IOK appears to be a safe option for those dealing with PTSD related to moral injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard PTSD treatments that often focus on trauma exposure or cognitive restructuring, the Impact of Killing (IOK) therapy takes a unique approach by specifically addressing moral injury. This treatment is designed for individuals dealing with the emotional and psychological impact of having killed in a combat situation, which is not typically the focus of traditional PTSD therapies like Cognitive Processing Therapy or Prolonged Exposure Therapy. Researchers are excited about IOK because it aims to help participants process and heal from the moral and ethical dilemmas they faced, potentially offering relief to a group that might not fully benefit from existing treatments. By targeting the moral injury aspect, IOK could provide a more tailored and effective treatment option for veterans and others with similar experiences.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Impact of Killing (IOK) therapy, one of the treatments in this trial, can significantly reduce PTSD symptoms. In one study, participants who received IOK therapy experienced fewer PTSD symptoms and other mental health issues compared to those who did not. They also reported an improved quality of life after treatment. IOK therapy addresses moral injury, which arises when actions during war, such as killing, conflict with personal beliefs. This approach has shown promise in helping Veterans manage their experiences and enhance their daily lives. Meanwhile, another group in this trial will receive Present Centered Therapy (PCT), which focuses on the functional impact of trauma without emphasizing trauma or cognitive restructuring. ^{1 2 3 6 7}

Who Is on the Research Team?

Shira Maguen, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9078088/

Treatment for Moral Injury: Impact of Killing in War - PMC In a pilot trial assessing IOK, participants demonstrated a reduction in multiple mental health symptoms and improvement in quality-of-life ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28294318/

Impact of Killing in War: A Randomized, Controlled Pilot Trial Results: We found that compared to controls (N = 16), the IOK group (N = 17) experienced a significant improvement in PTSD symptoms, general psychiatric ...

3. link.springer.com link.springer.com/article/10.1007/s40501-022-00262-6

Treatment for Moral Injury: Impact of Killing in War In a pilot trial assessing IOK, participants demonstrated a reduction in multiple mental health symptoms and improvement in quality-of-life ...

4. ptsd.va.gov ptsd.va.gov/publications/rq_docs/V33N1.pdf

Moral Injury Impact of Killing (IOK) is a cognitive behavioral intervention focused on moral injury from killing others in combat. (Maguen et al., 2017). Key themes ...

5. ctv.veeva.com ctv.veeva.com/study/a-novel-posttraumatic-stress-disorder-treatment-for-veterans-with-moral-injury

A Novel Posttraumatic Stress Disorder Treatment for Veterans ... 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 ...

6. mirecc.va.gov mirecc.va.gov/MIRECC/visn17/moralinjury/psychotherapy.asp

Moral Injury - MIRECC / CoE Two participants failed to complete treatment, one from each group. The IOK group had significantly greater reductions in PCL total scores compared to the ...

7. researchgate.net researchgate.net/publication/360450804_Treatment_for_Moral_Injury_Impact_of_Killing_in_War

(PDF) Treatment for Moral Injury: Impact of Killing in War Recent Findings In a pilot trial assessing IOK, participants demonstrated a reduction in multiple mental health symptoms and improvement in ...