Trial Outcomes & Findings for Improving Treatment Outcomes for Suicidal Veterans With PTSD (NCT NCT04690582)

Last Updated: 2024-12-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

157 participants

Primary outcome timeframe

Baseline (Pretreatment), 1 week, 2 weeks, 26 weeks, 52 weeks

Results posted on

2024-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	81	76
Overall Study COMPLETED	75	72
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	6	4

Baseline Characteristics

Improving Treatment Outcomes for Suicidal Veterans With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Plan n=81 Participants 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.	Crisis Response Plan n=76 Participants 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.	Total n=157 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	76 Participants n=5 Participants	66 Participants n=7 Participants	142 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	45.9 years STANDARD_DEVIATION 13.0 • n=5 Participants	48.3 years STANDARD_DEVIATION 12.1 • n=7 Participants	47.0 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	12 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	64 Participants n=7 Participants	115 Participants n=5 Participants
Race/Ethnicity, Customized White	63 Participants n=5 Participants	58 Participants n=7 Participants	121 Participants n=5 Participants
Race/Ethnicity, Customized Black	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Native American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Latino/Hispanic	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants	76 participants n=7 Participants	157 participants n=5 Participants
Scale for Suicide Ideation	5.91 units on a scale STANDARD_DEVIATION 7.79 • n=5 Participants	6.86 units on a scale STANDARD_DEVIATION 7.56 • n=7 Participants	6.37 units on a scale STANDARD_DEVIATION 7.67 • n=5 Participants
Number of Participants with Pre-Baseline Suicide Attempts	62 Participants n=5 Participants	63 Participants n=7 Participants	125 Participants n=5 Participants
National Stressful Events Survey PTSD Short Scale	27.01 units on a scale STANDARD_DEVIATION 7.09 • n=5 Participants	25.93 units on a scale STANDARD_DEVIATION 7.38 • n=7 Participants	26.49 units on a scale STANDARD_DEVIATION 7.23 • n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Safety Plan n=81 Participants 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.	Crisis Response Plan n=76 Participants 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.
Change in Suicide Ideation Baseline (Pretreatment)	5.91 units on a scale Standard Deviation 7.79	6.37 units on a scale Standard Deviation 7.67
Change in Suicide Ideation 1 week	3.67 units on a scale Standard Deviation 5.64	2.47 units on a scale Standard Deviation 4.83
Change in Suicide Ideation 2 weeks	3.00 units on a scale Standard Deviation 5.49	2.25 units on a scale Standard Deviation 5.18
Change in Suicide Ideation 26 weeks	3.49 units on a scale Standard Deviation 6.59	3.20 units on a scale Standard Deviation 6.22
Change in Suicide Ideation 52 weeks	3.42 units on a scale Standard Deviation 5.32	3.36 units on a scale Standard Deviation 5.37

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Safety Plan n=81 Participants 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.	Crisis Response Plan n=76 Participants 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.
Percent With Follow-up Suicidal Behaviors	4 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Safety Plan n=81 Participants 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.	Crisis Response Plan n=76 Participants 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.
Number of Follow-up Suicidal Behaviors	8 count of suicide attempts	4 count of suicide attempts

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Safety Plan n=81 Participants 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.	Crisis Response Plan n=76 Participants 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.
Change in PTSD Symptoms Baseline (Pretreatment)	27.01 units on a scale Standard Deviation 7.09	25.93 units on a scale Standard Deviation 7.38
Change in PTSD Symptoms 1 week	17.57 units on a scale Standard Deviation 7.59	18.05 units on a scale Standard Deviation 8.74
Change in PTSD Symptoms 2 weeks	13.42 units on a scale Standard Deviation 8.10	13.06 units on a scale Standard Deviation 6.85
Change in PTSD Symptoms 26 weeks	14.09 units on a scale Standard Deviation 9.22	14.87 units on a scale Standard Deviation 9.33
Change in PTSD Symptoms 52 weeks	14.85 units on a scale Standard Deviation 8.91	14.83 units on a scale Standard Deviation 9.44

Adverse Events

Safety Plan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crisis Response Plan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Craig Bryan, PsyD, ABPP

The Ohio State University College of Medicine

Phone: 614-814-8612

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place