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NCT04690582

Improving Treatment Outcomes for Suicidal Veterans With PTSD

Completed NA Results posted Last updated 20 December 2024
What this trial tests

NA trial testing Cognitive Processing Therapy (CPT) in Suicidal Ideation in 157 participants. Completed in 31 December 2023.

Timeline
15 January 2021
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorOhio State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment157
Start date15 January 2021
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ohio State University

Who can join

18 and older, any sex, with Suicidal Ideation or Suicide, Attempted. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Suicide Ideation Primary · Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks

Suicide ideation will be measured using the Scale for Suicide Ideation, an empirically-supported self-report scale that assesses the intensity of suicide-related thoughts, urges, intentions, and behaviors. Scores range from 0 to 38, with higher scores indicating more severe suicide ideation.

Baseline (Pretreatment)
GroupValue95% CI
Safety Plan5.91± 7.79
Crisis Response Plan6.37± 7.67
1 week
GroupValue95% CI
Safety Plan3.67± 5.64
Crisis Response Plan2.47± 4.83
2 weeks
GroupValue95% CI
Safety Plan3.00± 5.49
Crisis Response Plan2.25± 5.18
26 weeks
GroupValue95% CI
Safety Plan3.49± 6.59
Crisis Response Plan3.20± 6.22
52 weeks
GroupValue95% CI
Safety Plan3.42± 5.32
Crisis Response Plan3.36± 5.37
Percent With Follow-up Suicidal Behaviors Primary · 52 weeks

Percent of participants with one or more suicidal behaviors will be measured using the Self-Injurious Thoughts and Behaviors Interview-Revised, an empirically-supported self-report scale that assesses a range of self-injurious behaviors including suicide attempts, interrupted suicide attempts, preparatory behaviors, and non-suicidal self-injury during the 52 week follow-up. Suicidal behaviors will be coded with a binary variable indicating the presence or absence of any suicidal behavior during the study period.

GroupValue95% CI
Safety Plan4
Crisis Response Plan3
Number of Follow-up Suicidal Behaviors Primary · 52 weeks

Number of suicidal behaviors will be measured using the Self-Injurious Thoughts and Behaviors Interview-Revised, an empirically-supported self-report scale that assesses a range of self-injurious behaviors including suicide attempts, interrupted suicide attempts, preparatory behaviors, and non-suicidal self-injury during the 52 week follow-up. Suicidal behaviors will be coded with a binary variable indicating the presence or absence of any suicidal behavior during the study period and then summed to calculate the total number of suicidal behaviors during the 52 week follow-up.

GroupValue95% CI
Safety Plan8
Crisis Response Plan4
Change in PTSD Symptoms Secondary · Baseline (Pretreatment) , 1 week, 2 weeks, 26 weeks, 52 weeks

Change in PTSD symptom severity will be measured using the National Stressful Events Survey PTSD Short Scale. Scores range from 0 to 36, with higher scores indicating more severe PTSD symptoms.

Baseline (Pretreatment)
GroupValue95% CI
Safety Plan27.01± 7.09
Crisis Response Plan25.93± 7.38
1 week
GroupValue95% CI
Safety Plan17.57± 7.59
Crisis Response Plan18.05± 8.74
2 weeks
GroupValue95% CI
Safety Plan13.42± 8.10
Crisis Response Plan13.06± 6.85
26 weeks
GroupValue95% CI
Safety Plan14.09± 9.22
Crisis Response Plan14.87± 9.33
52 weeks
GroupValue95% CI
Safety Plan14.85± 8.91
Crisis Response Plan14.83± 9.44

Sponsor's own description

The efficacy of cognitive processing therapy (CPT) for reducing the symptoms of posttraumatic stress disorder (PTSD) across populations including military personnel and veterans is well supported. CPT also contributes to significant and rapid reductions in suicide ideation among people diagnosed with PTSD, although available evidence suggests this effect decays over time. Studies also show that approximately 1 in 6 people who begin CPT without suicide ideation will subsequently report suicidal thoughts at some point during or soon after completing treatment. Research focused on improving CPT's effects on suicide risk is therefore warranted. The primary aim of this study is to determine if the integration of a crisis response plan (CRP)--an empirically-supported procedure for reducing suicide ideation and attempts--can lead to faster reductions in suicide ideation among acutely suicidal veterans receiving CPT and prevent the development of suicide ideation among veterans who begin CPT without suicide ideation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparing the Impacts of Crisis Response Plan and Self-Administered Safety Plan Use in Real Life on Key Clinical Outcomes.
    Bozzay M, Cai X, Chen J, Daruwala S, et al · · 2025 · cited 1× · PMID 40938268 · DOI 10.1111/sltb.70050

Verify or expand the search:

Other trials of Cognitive Processing Therapy (CPT)

Trials testing the same drug.

Other recruiting trials for Suicidal Ideation

Currently open trials in the same condition.

Other Ohio State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04690582.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing