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Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06285708
Enrollment
100
Registered
2024-02-29
Start date
2024-02-26
Completion date
2027-06-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed 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.

Interventions

BEHAVIORALProlonged 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.

Sponsors

Ohio State University
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED
Congressionally Directed Medical Research Programs
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Beck Scale for Suicidal Ideation (SSI)During the first 3 weeks and through one year follow up19 item self-report assessment of suicidal ideation, range of scores is 0-57, higher score indicates higher suicidal ideation
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)During the first 3 weeks and through one year follow up31 item self-report measure of suicidal thoughts and behavior
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5)During the first 3 weeks and through one year follow up20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. range is 0-80, higher score indicates higher PTSD symptoms

Secondary

MeasureTime frameDescription
Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Self-Rated Level 1 Cross-Cutting Symptom MeasureDuring the first 3 weeks and through one year follow uptransdiagnostic 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.
Interpersonal Needs Questionnaire (INQ) - AbbreviatedDuring the first 3 weeks and through one year follow upself-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation.
Beck Hopelessness Scale (BHS) - AbbreviatedDuring the first 3 weeks and through one year follow upA 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome
Brief Suicide Cognitions Scale (SCS)During the first 3 weeks and through one year follow up6 item self-report assessment of thoughts related to suicidal ideation, range of scores is 0-30, higher score indicates worse outcome
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)During the first 3 weeks and through one year follow upself-report assessment of emotion regulation.
Monetary Choice Questionnaire (MCQ)During the first 3 weeks and through one year follow upa self-report assessment of impulsivity
Behavioral Inhibition Scale (BIS)During the first 3 weeks and through one year follow upa 7 item self-report assessment of punishment sensitivity, range 0-28, higher scores indicate worse outcome
Behavioral Activation Scale (BAS)During the first 3 weeks and through one year follow upa 13 item self-report assessment of reward sensitivity, range 0-52, higher scores indicate worse outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) MeasuresDuring the first 3 weeks and through one year follow upa 4 item self-report assessment of depression, range of scores 4-20, higher score indicates worse outcome

Countries

United States

Contacts

CONTACTJaryd Hiser, Ph.D.
jaryd.hiser@osumc.edu614-814-0163
PRINCIPAL_INVESTIGATORJaryd Hiser, Ph.D.

Assistant Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026