PTSDNCT06285708
Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
A study testing Prolonged exposure in people with PTSD and Suicidal Ideation, run by Ohio State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Jaryd Hiser, 614-814-0163, jaryd.hiser@osumc.edu
Justin Baker, Ph.D.
About this study
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.
Read the 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.
- Conditions
- PTSD, Suicidal Ideation, Suicide, Attempted, Trauma, Psychological
- Being tested
- Prolonged exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic, Suicidal Ideation, Suicide, Attempted, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged exposureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prolonged exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
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.
Measured: During the first 3 weeks and through one year follow up
Interpersonal Needs Questionnaire (INQ) - Abbreviated
self-report assessment of interpersonal factors (perceived burdensomeness and thwarted belongingness) that contribute to suicidal ideation.
Measured: During the first 3 weeks and through one year follow up
Beck Hopelessness Scale (BHS) - Abbreviated
A 5 item self-report assessment of hopelessness, range of scores is 0-10, higher scores indicate better outcome
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
self-report assessment of emotion regulation.
Measured: During the first 3 weeks and through one year follow up
Monetary Choice Questionnaire (MCQ)
a self-report assessment of impulsivity
Measured: During the first 3 weeks and through one year follow up
Behavioral Inhibition Scale (BIS)
a 7 item self-report assessment of punishment sensitivity, range 0-28, higher scores indicate worse outcome
Measured: During the first 3 weeks and through one year follow up
Behavioral Activation Scale (BAS)
a 13 item self-report assessment of reward sensitivity, range 0-52, higher scores indicate worse outcome
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
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
Measured: During the first 3 weeks and through one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start26 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Jaryd Hiser, Ohio State University
- Investigators
- Jaryd Hiser, Ph.D., Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285708
- Sponsor's protocol ID
- 2023B0193
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data available by request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD
- ClinicalTrials.gov ID
- NCT06285708
- Acronym / sponsor ID
- 2023B0193
- Conditions
- PTSD, Suicidal Ideation, Suicide, Attempted, Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged exposure with crisis response plan | Experimental | Behavioral: Prolonged exposureIn 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. |
| Prolonged exposure with safety plan | Active comparator | Behavioral: Prolonged exposureIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current diagnosis of PTSD or subthreshold PTSD; ability to speak and understand the English language; and ability to complete the informed consent process.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged exposurePE 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. | Behavioural | Prolonged exposure with crisis response plan, Prolonged exposure with safety plan |
Primary outcome
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
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
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
15 secondary outcomes
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
Interpersonal Needs Questionnaire (INQ) - Abbreviated
Time frame: During the first 3 weeks and through one year follow up
Beck Hopelessness Scale (BHS) - Abbreviated
Time frame: During the first 3 weeks and through one year follow up
Brief Suicide Cognitions Scale (SCS)
Time frame: During the first 3 weeks and through one year follow up
Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
Time frame: During the first 3 weeks and through one year follow up
Monetary Choice Questionnaire (MCQ)
Time frame: During the first 3 weeks and through one year follow up
Behavioral Inhibition Scale (BIS)
Time frame: During the first 3 weeks and through one year follow up
Behavioral Activation Scale (BAS)
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Patient-Reported Outcomes Measurement Information System (PROMIS) Measures
Time frame: During the first 3 weeks and through one year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data available by request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaryd Hiser, Ph.D. principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged exposure in people with PTSD and Suicidal Ideation, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaryd Hiser, Ph.D. (614-814-0163, jaryd.hiser@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Scale for Suicidal Ideation (SSI) (time frame: During the first 3 weeks and through one year follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.