CompletedNot Applicable

Improving Treatment Outcomes for Suicidal Veterans With PTSD

United States157 participantsStarted 2021-01-15

Plain-language summary

The efficacy of cognitive processing therapy (CPT) for reducing the symptoms of posttraumatic stress disorder (PTSD) across populations including military personnel and veterans is well supported. CPT also contributes to significant and rapid reductions in suicide ideation among people diagnosed with PTSD, although available evidence suggests this effect decays over time. Studies also show that approximately 1 in 6 people who begin CPT without suicide ideation will subsequently report suicidal thoughts at some point during or soon after completing treatment. Research focused on improving CPT's effects on suicide risk is therefore warranted. The primary aim of this study is to determine if the integration of a crisis response plan (CRP)--an empirically-supported procedure for reducing suicide ideation and attempts--can lead to faster reductions in suicide ideation among acutely suicidal veterans receiving CPT and prevent the development of suicide ideation among veterans who begin CPT without suicide ideation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years of age or older * Current or prior service in the U.S. military * Current diagnosis of PTSD or subthreshold PTSD * Ability to speak and understand the English language * Ability to complete the informed consent process. Exclusion Criteria: * Substance use disorder requiring medical management * Imminent suicide risk warranting inpatient hospitalization or suicide-focused treatment * Impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Suicide Ideation

Timeframe: Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks

Percent With Follow-up Suicidal Behaviors

Timeframe: 52 weeks

Number of Follow-up Suicidal Behaviors

Timeframe: 52 weeks

Trial details

NCT IDNCT04690582

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

Results submitted2024-07-14

View on ClinicalTrials.gov More Suicidal Ideation trials