Improving Treatment Outcomes for Suicidal Veterans With PTSD

NCT04690582 | Completed Results

• 1 other identifier: 2020H0431
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide, Attempted; Ptsd

Keywords

crisis response plan; safety planning; safety plan

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Number of Follow-up Suicidal Behaviors

  Number of 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 and then summed to calculate the total number of suicidal behaviors during the 52 week follow-up.

  52 weeks

Secondary Outcomes (1)

• Change in PTSD Symptoms

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

Study Arms (2)

Treatment As Usual

ACTIVE COMPARATOR

Participants will receive cognitive processing therapy (CPT) for PTSD combined with a self-guided safety plan. As a recommended standard care practice with suicidal patients, the combination of CPT and safety plan represents treatment as usual. The safety plan will be assigned during the first therapy session.

Behavioral: Cognitive Processing Therapy (CPT); Behavioral: Safety Planning Intervention (SPI)

Crisis Response Plan (CPT+CRP)

EXPERIMENTAL

Participants will receive cognitive processing therapy (CPT) for PTSD combined with a collaborative crisis response plan (CRP). The CRP includes many of the same elements as the safety plan (i.e., warning signs, self-management strategies, sources of social support, crisis services), but is created collaboratively by the patient with active input of their clinician rather than being self-guided. The CRP also includes a section focused on the participant's reasons for living, an addition that has been shown to increase positive emotional states (e.g., hope, optimism) and lead to faster reductions in suicidal intent. The CRP will be collaboratively created during the first therapy session.

Behavioral: Cognitive Processing Therapy (CPT); Behavioral: Crisis Response Plan (CRP); Behavioral: Narrative Assessment

Interventions

Cognitive Processing Therapy (CPT) BEHAVIORAL

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 (CPT+CRP); Treatment As Usual

Crisis Response Plan (CRP) BEHAVIORAL

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.

Crisis Response Plan (CPT+CRP)

Safety Planning Intervention (SPI) BEHAVIORAL

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.

Treatment As Usual

Narrative Assessment BEHAVIORAL

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.

Crisis Response Plan (CPT+CRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Craig Bryan, PsyD, ABPP
• Organization: The Ohio State University College of Medicine

craig.bryan@osumc.edu

614-814-8612

Study Officials

• Craig Bryan, PsyD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stress, Trauma, and Resilience (STAR) Professor

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: January 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of primary results
• Access Criteria: All requests for data and/or code use will be reviewed by the PIs and co-Is and a majority vote will be used to determine whether the request is approved or not. If the request is approved, Dr. Bryan will inform the requestor, return a signed copy of the completed Data Use Request Form to the requestor, and let the requestor know that written IRB approval of the requestor's proposed study from the requestor's home institution will be required before data and/or code will be shared with the requestor. If a request is approved pending revision to the Data Use Request Form, Dr. Bryan will work with requestors to revise sections of their Data Use Request Forms in order to obtain approval. If the request is not approved, Dr. Bryan will inform the requestor and returned a signed copy of the completed Data Use Request Form to the requestor that includes an explanation for the denial.

Locations

US (1)