Skip to content

Improving Treatment Outcomes for Suicidal Veterans With PTSD

Enhancing the Effectiveness of Cognitive Processing Therapy Among Suicidal Military Veterans With PTSD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04690582
Enrollment
157
Registered
2020-12-30
Start date
2021-01-15
Completion date
2023-12-31
Last updated
2024-12-20

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

Keywords

crisis response plan, safety planning, safety plan

Brief summary

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.

Detailed description

Cognitive behavioral treatments tend to be the most highly efficacious treatments for PTSD. Cognitive Processing Therapy (CPT) is one such treatment that has garnered a significant amount of empirical support, with a recent metaanalysis showing it was the most effective treatment for PTSD, typically yielding a 50% or larger reduction in PTSD symptoms from pre- to posttreatment. Redutions in PTSD symptoms are similar in magnitude when CPT is delivered in a virtual or telehealth format as compared to face-to-face delivery. Long-term follow-up studies conducted in nonmilitary samples also suggest the beneficial effects of CPT endure for up to 10 years posttreatment. Clinical improvement and recovery rates tend to be higher among patients who complete CPT compared to those that drop out of treatment early. Data also suggest that PTSD outcomes are moderated by session frequency, such that CPT sessions spaced closer together yield better effects than CPT sessions that are spaced further apart. In addition to reducing PTSD symptoms, recent studies indicate CPT is also associated with significant short-term reduction in suicide ideation, potentially due to its effects on PTSD and depression symptom severity. In some studies, suicide ideation increased in severity again several months after the conclusion of therapy, however, suggesting a period of increased vulnerability for suicide. Enhancing CPT 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. One such procedure is the crisis response plan (CRP), a collaborative, patient-centered intervention that is typically handwritten on an index cards and focuses on several key components: (1) warning signs, (2) self-regulatory strategies, (3) reasons for living, (4) sources of social support, and (5) professional and crisis services. In a randomized clinical trial previously conducted by our team, acutely suicidal patients who received a CRP showed significantly faster declines in suicide ideation and were 76% less likely to attempt suicide during the 6-month follow-up as compared to patients who received mental health treatment as usual. In the present study, the investigators aim to determine if the addition of a CRP with CPT will lead to faster reductions in suicide ideation and prevent the recurrence of suicide ideation during follow-up as compared to the standard provision of CPT. To achieve this, this study includes a two-arm, double blind parallel randomized clinical trial. The investigators will enroll 150 military personnel and veterans who meet full diagnostic criteria for PTSD (i.e., having 4 of 4 symptom criteria at or above threshold levels) or subthreshold PTSD (i.e., having 3 of 4 symptom criteria at or above threshold levels). All participants will receive 10-12 sessions of CPT, administered on a daily basis for two consecutive weeks. The investigators will assess suicide ideation, suicide attempts, and psychological symptom severity for up to one year post-treatment. Our primary hypothesis is that the combination of CRP and CPT will result in larger reductions in suicide ideation than CPT alone.

Interventions

Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.

BEHAVIORALCrisis Response Plan (CRP)

The crisis response plan (CRP) is a collaborative, patient-centered intervention that is typically handwritten on an index cards and focuses on several key components: (1) warning signs, (2) self-regulatory strategies, (3) reasons for living, (4) sources of social support, and (5) professional and crisis services.

The safety planning intervention (SPI) is a suicide-focused intervention typically handwritten on a pre-printed form that includes the following sections: (1) warning signs, (2) internal coping strategies, (3) people and social settings that provide distraction, (4) people who can offer help, (5) professionals or agencies they can contact during a crisis, and (6) making the environment safe.

The narrative assessment is a patient-centered assessment approach in which the clinician invites the patient to share the story of a recent crisis or period of intense emotional distress. Patients are asked to identify the thoughts, emotions, and physical sensations experienced in the time leading up to this crisis, as well as the contextual and environmental characteristics surrounding the crisis. Information obtained from the narrative assessment is then used to help formulate a crisis response plan.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* 18 years of age or older * Current or prior service in the U.S. military * Current diagnosis of PTSD or subthreshold PTSD * Ability to speak and understand the English language * 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 * Impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania)

Design outcomes

Primary

MeasureTime frameDescription
Change in Suicide IdeationBaseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeksSuicide 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.
Percent With Follow-up Suicidal Behaviors52 weeksPercent 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.
Number of Follow-up Suicidal Behaviors52 weeksNumber 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.

Secondary

MeasureTime frameDescription
Change in PTSD SymptomsBaseline (Pretreatment) , 1 week, 2 weeks, 26 weeks, 52 weeksChange 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Safety Plan
Participants will receive cognitive processing therapy (CPT) for PTSD combined with a self-guided safety plan. As a recommended standard care practice with suicidal patients, the combination of CPT and safety plan represents treatment as usual. The safety plan will be assigned during the first therapy session. Safety Plan (SP): Safety planning (SP) is a suicide-focused intervention typically handwritten on a pre-printed form that includes the following sections: (1) warning signs, (2) internal coping strategies, (3) people and social settings that provide distraction, (4) people who can offer help, (5) professionals or agencies they can contact during a crisis, and (6) making the environment safe.
81
Crisis Response Plan
Participants will receive cognitive processing therapy (CPT) for PTSD combined with a collaborative crisis response plan (CRP). The CRP 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 begins with a narrative suicide risk assessment, in which the patient is invited to tell the story of their suicidal thoughts and/or behaviors. 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 collaboratively created during the first therapy session. Crisis Response Plan (CRP): The crisis response plan (CRP) is a collaborative, patient-centered intervention that is typically handwritten on an index cards and focuses on several key components: (1) warning signs, (2) self-regulatory strategies, (3) reasons for living, (4) sources of social support, and (5) professional and crisis services.
76
Total157

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject64

Baseline characteristics

CharacteristicSafety PlanCrisis Response PlanTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants10 Participants15 Participants
Age, Categorical
Between 18 and 65 years
76 Participants66 Participants142 Participants
Age, Continuous45.9 years
STANDARD_DEVIATION 13
48.3 years
STANDARD_DEVIATION 12.1
47.0 years
STANDARD_DEVIATION 12.6
National Stressful Events Survey PTSD Short Scale27.01 units on a scale
STANDARD_DEVIATION 7.09
25.93 units on a scale
STANDARD_DEVIATION 7.38
26.49 units on a scale
STANDARD_DEVIATION 7.23
Number of Participants with Pre-Baseline Suicide Attempts62 Participants63 Participants125 Participants
Race/Ethnicity, Customized
Asian
2 Participants2 Participants4 Participants
Race/Ethnicity, Customized
Black
9 Participants7 Participants16 Participants
Race/Ethnicity, Customized
Latino/Hispanic
3 Participants10 Participants13 Participants
Race/Ethnicity, Customized
Native American
3 Participants2 Participants5 Participants
Race/Ethnicity, Customized
Other
4 Participants7 Participants11 Participants
Race/Ethnicity, Customized
White
63 Participants58 Participants121 Participants
Region of Enrollment
United States
81 participants76 participants157 participants
Scale for Suicide Ideation5.91 units on a scale
STANDARD_DEVIATION 7.79
6.86 units on a scale
STANDARD_DEVIATION 7.56
6.37 units on a scale
STANDARD_DEVIATION 7.67
Sex: Female, Male
Female
30 Participants12 Participants42 Participants
Sex: Female, Male
Male
51 Participants64 Participants115 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 810 / 76
other
Total, other adverse events
0 / 810 / 76
serious
Total, serious adverse events
0 / 810 / 76

Outcome results

Primary

Change in Suicide Ideation

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.

Time frame: Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Safety PlanChange in Suicide Ideation52 weeks3.42 units on a scaleStandard Deviation 5.32
Safety PlanChange in Suicide IdeationBaseline (Pretreatment)5.91 units on a scaleStandard Deviation 7.79
Safety PlanChange in Suicide Ideation1 week3.67 units on a scaleStandard Deviation 5.64
Safety PlanChange in Suicide Ideation2 weeks3.00 units on a scaleStandard Deviation 5.49
Safety PlanChange in Suicide Ideation26 weeks3.49 units on a scaleStandard Deviation 6.59
Crisis Response PlanChange in Suicide Ideation26 weeks3.20 units on a scaleStandard Deviation 6.22
Crisis Response PlanChange in Suicide Ideation2 weeks2.25 units on a scaleStandard Deviation 5.18
Crisis Response PlanChange in Suicide IdeationBaseline (Pretreatment)6.37 units on a scaleStandard Deviation 7.67
Crisis Response PlanChange in Suicide Ideation52 weeks3.36 units on a scaleStandard Deviation 5.37
Crisis Response PlanChange in Suicide Ideation1 week2.47 units on a scaleStandard Deviation 4.83
Primary

Number of Follow-up Suicidal Behaviors

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.

Time frame: 52 weeks

ArmMeasureValue (NUMBER)
Safety PlanNumber of Follow-up Suicidal Behaviors8 count of suicide attempts
Crisis Response PlanNumber of Follow-up Suicidal Behaviors4 count of suicide attempts
Primary

Percent With Follow-up Suicidal Behaviors

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.

Time frame: 52 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Safety PlanPercent With Follow-up Suicidal Behaviors4 Participants
Crisis Response PlanPercent With Follow-up Suicidal Behaviors3 Participants
Secondary

Change in PTSD Symptoms

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.

Time frame: Baseline (Pretreatment) , 1 week, 2 weeks, 26 weeks, 52 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Safety PlanChange in PTSD SymptomsBaseline (Pretreatment)27.01 units on a scaleStandard Deviation 7.09
Safety PlanChange in PTSD Symptoms2 weeks13.42 units on a scaleStandard Deviation 8.1
Safety PlanChange in PTSD Symptoms1 week17.57 units on a scaleStandard Deviation 7.59
Safety PlanChange in PTSD Symptoms26 weeks14.09 units on a scaleStandard Deviation 9.22
Safety PlanChange in PTSD Symptoms52 weeks14.85 units on a scaleStandard Deviation 8.91
Crisis Response PlanChange in PTSD Symptoms26 weeks14.87 units on a scaleStandard Deviation 9.33
Crisis Response PlanChange in PTSD Symptoms52 weeks14.83 units on a scaleStandard Deviation 9.44
Crisis Response PlanChange in PTSD SymptomsBaseline (Pretreatment)25.93 units on a scaleStandard Deviation 7.38
Crisis Response PlanChange in PTSD Symptoms1 week18.05 units on a scaleStandard Deviation 8.74
Crisis Response PlanChange in PTSD Symptoms2 weeks13.06 units on a scaleStandard Deviation 6.85

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026