Clinical trial NCT04690582: Improving Treatment Outcomes for Suicidal Veterans With PTSD
Official title: Enhancing the Effectiveness of Cognitive Processing Therapy Among Suicidal Military Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicide, Attempted
Ptsd
Keywords: crisis response plan
safety planning
safety plan
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Cognitive behavioral treatments tend to be the most highly efficacious treatments for PTSD. Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was the most effective treatment for PTSD, typically yielding a 50% or larger reduction in PTSD symptoms from pre- to posttreatment. Redutions in PTSD symptoms are similar in magnitude when CPT is delivered in a virtual or telehealth format as compared to face-to-face delivery. Long-term follow-up studies conducted in nonmilitary samples also suggest the beneficial effects of CPT endure for up to 10 years posttreatment. Clinical improvement and recovery rates tend to be higher among patients who complete CPT compared to those that drop out of treatment early. Data also suggest that PTSD outcomes are moderated by session frequency, such that CPT sessions spaced closer together yield better effects than CPT sessions that are spaced further apart.

In addition to reducing PTSD symptoms, recent studies indicate CPT is also associated with significant short-term reduction in suicide ideation, potentially due to its effects on PTSD and depression symptom severity. In some studies, suicide ideation increased in severity again several months after the conclusion of therapy, however, suggesting a period of increased vulnerability for suicide. Enhancing CPT with procedures that have been shown to significantly reduce suicidal thoughts and behaviors could serve to further reduce suicide risk during and after treatment completion. One such procedure is the crisis response plan (CRP), a collaborative, patient-centered intervention that is typically handwritten on an index cards and focuses on several key components: (1) warning signs, (2) self-regulatory strategies, (3) reasons for living, (4) sources of social support, and (5) professional and crisis services. In a randomized clinical trial previously conducted by our team, acutely suicidal patients who received a CRP showed significantly faster declines in suicide ideation and were 76% less likely to attempt suicide during the 6-month follow-up as compared to patients who received mental health treatment as usual.

In the present study, the investigators aim to determine if the addition of a CRP with CPT will lead to faster reductions in suicide ideation and prevent the recurrence of suicide ideation during follow-up as compared to the standard provision of CPT. To achieve this, this study includes a two-arm, double blind parallel randomized clinical trial. The investigators will enroll 150 military personnel and veterans who meet full diagnostic criteria for PTSD (i.e., having 4 of 4 symptom criteria at or above threshold levels) or subthreshold PTSD (i.e., having 3 of 4 symptom criteria at or above threshold levels). All participants will receive 10-12 sessions of CPT, administered on a daily basis for two consecutive weeks. The investigators will assess suicide ideation, suicide attempts, and psychological symptom severity for up to one year post-treatment. Our primary hypothesis is that the combination of CRP and CPT will result in larger reductions in suicide ideation than CPT alone.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Suicide Ideation
timeFrame: Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks
measure: Percent With Follow-up Suicidal Behaviors
timeFrame: 52 weeks
measure: Number of Follow-up Suicidal Behaviors
timeFrame: 52 weeks
Secondary outcomes:
measure: Change in PTSD Symptoms
timeFrame: Baseline (Pretreatment) , 1 week, 2 weeks, 26 weeks, 52 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Craig Bryan, PsyD
role: PRINCIPAL_INVESTIGATOR
References: