Improving Treatment Outcomes for Suicidal Veterans With PTSD

Ptsd Clinical Trial

Official title:

Enhancing the Effectiveness of Cognitive Processing Therapy Among Suicidal Military Veterans With PTSD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04690582
• Other study ID #: 2020H0431
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ptsd
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Cognitive Processing Therapy (CPT)
Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.
• Crisis Response Plan (CRP)
The crisis response plan (CRP) is 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.
• Safety Planning Intervention (SPI)
The safety planning intervention (SPI) is a suicide-focused intervention typically handwritten on a pre-printed form that includes the following sections: (1) warning signs, (2) internal coping strategies, (3) people and social settings that provide distraction, (4) people who can offer help, (5) professionals or agencies they can contact during a crisis, and (6) making the environment safe.
• Narrative Assessment
The narrative assessment is a patient-centered assessment approach in which the clinician invites the patient to share "the story" of a recent crisis or period of intense emotional distress. Patients are asked to identify the thoughts, emotions, and physical sensations experienced in the time leading up to this crisis, as well as the contextual and environmental characteristics surrounding the crisis. Information obtained from the narrative assessment is then used to help formulate a crisis response plan.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in suicide ideation	Suicide ideation will be measured using the Scale for Suicide Ideation, an empirically-supported self-report scale that assesses the intensity of suicide-related thoughts, urges, intentions, and behaviors. Scores range from 0 to 38, with higher scores indicating more severe suicide ideation.	Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks
Primary	Percent with follow-up suicidal behaviors	Percent of participants with one or more suicidal behaviors will be measured using the Self-Injurious Thoughts and Behaviors Interview-Revised, an empirically-supported self-report scale that assesses a range of self-injurious behaviors including suicide attempts, interrupted suicide attempts, preparatory behaviors, and non-suicidal self-injury during the 52 week follow-up. Suicidal behaviors will be coded with a binary variable indicating the presence or absence of any suicidal behavior during the study period.	52 weeks
Secondary	Change in PTSD symptoms	Change in PTSD symptom severity will be measured using the National Stressful Events Survey PTSD Short Scale. Scores range from 0 to 36, with higher scores indicating more severe PTSD symptoms.	Baseline (Pretreatment) , 1 week, 2 weeks, 26 weeks, 52 weeks
Secondary	Change in psychiatric symptoms	Psychiatric symptom severity will be measured using the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure, a 23-item self-report scale of symptoms that cut across 13 diagnostic domains (e.g., depression, anger, mania, anxiety, psychosis, etc.).	Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks
Secondary	Change in psychological well-being	Psychological well-being will be measured using the Ryff Scales of Psychological Well-Being. Scores range from 18 to 126, with higher scores indicating higher levels of well-being.	Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks