Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

NCT06285708 | Recruiting

• 1 other identifier: 2023B0193
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

Conditions

PTSD; Suicidal Ideation; Suicide, Attempted; Trauma, Psychological

Outcome Measures

Primary Outcomes (3)

• Beck Scale for Suicidal Ideation (SSI)

  19 item self-report assessment of suicidal ideation, range of scores is 0-57, higher score indicates higher suicidal ideation

  During the first 3 weeks and through one year follow up

• Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)

  31 item self-report measure of suicidal thoughts and behavior

  During the first 3 weeks and through one year follow up

• PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)

  20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. range is 0-80, higher score indicates higher PTSD symptoms

  During the first 3 weeks and through one year follow up

Secondary Outcomes (15)

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure

  During the first 3 weeks and through one year follow up

• Interpersonal Needs Questionnaire (INQ) - Abbreviated

  During the first 3 weeks and through one year follow up

• Beck Hopelessness Scale (BHS) - Abbreviated

  During the first 3 weeks and through one year follow up

• Brief Suicide Cognitions Scale (SCS)

  During the first 3 weeks and through one year follow up

• Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)

  During the first 3 weeks and through one year follow up

Study Arms (2)

Prolonged exposure with crisis response plan

EXPERIMENTAL

In the enhanced prolonged exposure condition, participants will complete a CRP instead of a safety plan. The CRP is another recommended standard care practice with suicidal patients that 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 administered during the first therapy session.

Behavioral: Prolonged exposure

Prolonged exposure with safety plan

ACTIVE COMPARATOR

In the standard prolonged exposure condition, participants will complete a safety plan, a procedure that includes personal warning signs for a suicidal crisis, self-management strategies, sources of social support, and contact information for professional resources and crisis services within the participant's local community, as well as the National Suicide Prevention Lifeline phone number. As a recommended standard care practice with suicidal patients, the combination of PE and safety plan represents treatment as usual. The safety plan will be administered during the first therapy session.

Behavioral: Prolonged exposure

Interventions

Prolonged exposure BEHAVIORAL

PE therapy is a manualized cognitive behavioral therapy consisting of imaginal exposure (repeated recounting of the most disturbing traumatic memory) followed by processing thoughts and feelings related to the imaginal experience; in-vivo exposure (approaching trauma-related situations); psychoeducation about PTSD; and controlled breathing training. Between sessions, participants listen to audio recordings of the imaginal recounting daily and complete in-vivo exercises. Typically, PE is delivered weekly for 10-12, 90-minutes sessions. For this study, participants will complete daily 60-minute sessions for 10 consecutive weekdays during a 2-week period.

Prolonged exposure with crisis response plan; Prolonged exposure with safety plan

Eligibility Criteria

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

You may qualify if:

• Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and 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; and 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

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Jaryd Hiser, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaryd Hiser, Ph.D.

CONTACT

614-814-0163; jaryd.hiser@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 29, 2024
• Study Start: February 26, 2024
• Primary Completion: July 1, 2025
• Study Completion: January 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)