Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

PTSD Clinical Trial

Official title:

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285708
• Other study ID #: 2023B0193
• Status: Recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Jaryd Hiser, Ph.D.
• Phone: 614-814-0163
• Email: jaryd.hiser[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Posttraumatic stress disorder (PTSD) is associated with a host of functional problems and negative outcomes, including occupational and marital dissatisfaction, violence, alcohol and substance abuse, and suicide. Cognitive behavioral treatments tend to be the most highly efficacious treatments for PTSD. Prolonged Exposure (PE) therapy is a manualized cognitive behavioral therapy consisting of imaginal exposure followed by processing thoughts and feelings related to the imaginal experience; in-vivo exposure, psychoeducation, and controlled breathing training. Preliminary evidence suggests that PE is associated with significant suicidal ideation (SI) reductions. Enhancing PE 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. The long-term goal of this project is to prevent suicides among individuals diagnosed with PTSD by integrating trauma-focused therapies with suicide-focused interventions. The primary objective of this pilot project is to test the efficacy of PE when enhanced with a crisis response plan utilizing self-report, behavioral, and ecological assessment methods to compare treatment effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and 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; and impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Prolonged exposure
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.

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	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
Primary	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
Primary	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	Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom Measure	transdiagnostic measure of current mental health symptomatology. It is an adult measure that consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use.	During the first 3 weeks and through one year follow up
Secondary	Interpersonal Needs Questionnaire (INQ) - Abbreviated	self-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation.	During the first 3 weeks and through one year follow up
Secondary	Beck Hopelessness Scale (BHS) - Abbreviated	A 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome	During the first 3 weeks and through one year follow up
Secondary	Brief Suicide Cognitions Scale (SCS)	6 item self-report assessment of thoughts related to suicidal ideation, range of scores is 0-30, higher score indicates worse outcome	During the first 3 weeks and through one year follow up
Secondary	Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)	self-report assessment of emotion regulation.	During the first 3 weeks and through one year follow up
Secondary	Monetary Choice Questionnaire (MCQ)	a self-report assessment of impulsivity	During the first 3 weeks and through one year follow up
Secondary	Behavioral Inhibition Scale (BIS)	a 7 item self-report assessment of punishment sensitivity, range 0-28, higher scores indicate worse outcome	During the first 3 weeks and through one year follow up
Secondary	Behavioral Activation Scale (BAS)	a 13 item self-report assessment of reward sensitivity, range 0-52, higher scores indicate worse outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 4 item self-report assessment of depression, range of scores 4-20, higher score indicates worse outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 4 item self-report assessment of anxiety, range of scores 4-20, higher scores indicate worse outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 4 item self-report assessment of social activity, range of scores is 4-20, higher score indicates worse outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 4 item self-report assessment of fatigue, range of scores is 4-20, higher scores indicate worse outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 4 item self-report assessment of sleep, range of scores is 4-20, higher scores indicate worse outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 4 item self-report assessment of physical function, range of scores is 4-20, higher score indicates better outcome	During the first 3 weeks and through one year follow up
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS) Measures	a 5 item self-report assessment of pain, range of scores 5-25, higher scores indicates worse outcome	During the first 3 weeks and through one year follow up