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NCT Number: NCT06285708

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

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.

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Key information

Conditions

PTSD Behavior Behavioral Symptoms Mental Disorders Psychological Trauma Self-Injurious Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Suicidal Ideation Suicide Suicide, Attempted Trauma and Stressor Related Disorders Trauma, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Jaryd Hiser

CONTACT

[email protected]

614-814-0163

Justin Baker, Ph.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Beck Scale for Suicidal Ideation (SSI)

    Time frame: During the first 3 weeks and through one year follow up

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

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

    Time frame: During the first 3 weeks and through one year follow up

    31 item self-report measure of suicidal thoughts and behavior

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

    Time frame: During the first 3 weeks and through one year follow up

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

Secondary outcomes

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

    Time frame: During the first 3 weeks and through one year follow up

    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.

  2. Interpersonal Needs Questionnaire (INQ) - Abbreviated

    Time frame: During the first 3 weeks and through one year follow up

    self-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation.

  3. Beck Hopelessness Scale (BHS) - Abbreviated

    Time frame: During the first 3 weeks and through one year follow up

    A 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome

  4. Brief Suicide Cognitions Scale (SCS)

    Time frame: During the first 3 weeks and through one year follow up

    6 item self-report assessment of thoughts related to suicidal ideation, range of scores is 0-30, higher score indicates worse outcome

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

    Time frame: During the first 3 weeks and through one year follow up

    self-report assessment of emotion regulation.

  6. Monetary Choice Questionnaire (MCQ)

    Time frame: During the first 3 weeks and through one year follow up

    a self-report assessment of impulsivity

  7. Behavioral Inhibition Scale (BIS)

    Time frame: During the first 3 weeks and through one year follow up

    a 7 item self-report assessment of punishment sensitivity, range 0-28, higher scores indicate worse outcome

  8. Behavioral Activation Scale (BAS)

    Time frame: During the first 3 weeks and through one year follow up

    a 13 item self-report assessment of reward sensitivity, range 0-52, higher scores indicate worse outcome

  9. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 4 item self-report assessment of depression, range of scores 4-20, higher score indicates worse outcome

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 4 item self-report assessment of anxiety, range of scores 4-20, higher scores indicate worse outcome

  11. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 4 item self-report assessment of social activity, range of scores is 4-20, higher score indicates worse outcome

  12. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 4 item self-report assessment of fatigue, range of scores is 4-20, higher scores indicate worse outcome

  13. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 4 item self-report assessment of sleep, range of scores is 4-20, higher scores indicate worse outcome

  14. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 4 item self-report assessment of physical function, range of scores is 4-20, higher score indicates better outcome

  15. Patient-Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: During the first 3 weeks and through one year follow up

    a 5 item self-report assessment of pain, range of scores 5-25, higher scores indicates worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Jaryd Hiser, Ph.D.

CONTACT

[email protected]

614-814-0163

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • United States Department of Defense

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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