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Integration of PE & Coping Long-Term With Active Suicide Program for PTSD & Suicide Risk in Military Families

Primary Purpose

Post Traumatic Stress Disorder, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLASP-PE arm
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to read and write in English. This is essential in order to complete the informed consent, self-report questionnaires, and homework assignments for the study.
  • Diagnosis of PTSD according to the Clinician Administered PTSD Scale (CAPS). This is essential for the aims of the study, which include primarily to demonstrate a reduction in PTSD-related distress and ultimately in suicidal behaviors and thoughts.
  • Suicidal ideation (SI) with a plan and/or a history of suicide attempts (SA). This is essential for the aims of the study, which include primarily to demonstrate a reduction in suicidal behaviors and thoughts as well as in PTSD related distress.
  • Active duty service member
  • Willingness to sign a release of information to allow for continuous communication between research study staff and treatment providers or between the research study staff and external mental health providers in order to ensure that any important information between the patient and their care team can be shared openly between the participating center and research staff involved in the patients care or assessment.

Exclusion Criteria:

  • Current psychotic or manic episode as indicated by the MINI International Neuropsychiatric Interview. While it is possible that the intervention may be effective in individuals with psychosis, the research community needs to demonstrate the overall success of the intervention before it is applied to specialized subgroups, like individuals with psychosis. The intervention may also be eventually useful for individuals with a bipolar illness(defined by the presence of manic episodes) but likely that would require stabilization of mania prior to intervention implementation. As such these individuals will be excluded from the current study, though should possibly be included in future research depending on the results of the study.
  • Current substance use disorder, severe (in the past terminology "dependence") that would preclude the ability to focus on PTSD and suicide symptom reduction. As with key exclusion criterion above, it is possible that individuals with a principal substance use disorder diagnosis may benefit from the intervention. However, the research community needs to demonstrate the overall success of the intervention (including in individuals with comorbid, but not principal) substance use disorders before it is applied in those with a principal substance use disorder.
  • Current alternative evidence-based PTSD or suicide-focused individual psychotherapy, including current individual weekly Prolonged Exposure, current individual weekly Cognitive Processing Therapy, and current individual Coping LongTerm with Active Suicide Program (CLASP). Active involvement in an evidence-based PTSD or suicide-focused therapy would preclude the ability to scientifically test the effect of the intervention.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLASP-PE arm

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CAPS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CAPS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CPAS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CPAS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Number of patients with anxiety, mood, psychotic, substance, and eating disorders as assessed by the MINI International Neuropsychiatric Interview (MINI)
Extent to which client was satisfied with the training as assessed by the Client Satisfaction Questionnaire (CSQ)
The CSQ is an 8-item measure of client satisfaction rated on a 1-4 point Likert scale. A higher score indicates a higher satisfaction.
Feedback form participants as assessed by the Qualitative interview(QI) which will include a series of open ended questions aimed at eliciting feedback from participants about their perspective on the PE-CLASP Intervention

Secondary Outcome Measures

Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.

Full Information

First Posted
February 20, 2020
Last Updated
October 31, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04284410
Brief Title
Integration of PE & Coping Long-Term With Active Suicide Program for PTSD & Suicide Risk in Military Families
Official Title
Integration of Prolonged Exposure (PE) and Coping Long-Term With Active Suicide Program (CLASP) for PTSD and Suicide Risk in Military Families
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2021 (Actual)
Primary Completion Date
September 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to develop an innovative, safe, acceptable, feasible, and efficacious integrated CLASP-PE intervention and to Collect pilot data to evaluate the preliminary evidence of the promise of the intervention. We hypothesize that the CLASP-PE intervention will demonstrate safety, acceptability, feasibility, and efficacy in the open trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Suicidal Ideation
Keywords
depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLASP-PE arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CLASP-PE arm
Intervention Description
Participants will complete 8-16 weekly or twice weekly individual therapy sessions (with total session number determined by clinical need, as is typical in clinical trials of PE for PTSD), 1 therapy session (session 3) with a supportive significant other (SO), consistent with the CLASP protocol, and 11 brief (30 minute) phone calls as possible, with calls occurring every week in between therapy sessions and on a less frequent basis following treatment termination up to 3 months after the final in-person therapy session. In addition, the supportive SOs will complete 11 brief (30 minute) phone calls with the therapist at the same frequency as participants. Participants will sign a release of information prior to involving the supportive significant other in treatment.
Primary Outcome Measure Information:
Title
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
Description
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CAPS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Time Frame
Baseline
Title
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
Description
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CAPS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
Description
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CPAS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Time Frame
3 months post treatment
Title
Number of participants with a diagnosis of post-traumatic stress syndrome(PTSD)as assessed by The Clinician Administered PTSD Scale for DSM 5 (CAPS 5)
Description
The CAPS 5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week.The CPAS-5 total score ranges from 0(absent) to 4(extreme/incapacitating)
Time Frame
6 months post treatment
Title
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
Description
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
Time Frame
Baseline
Title
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
Description
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
Time Frame
before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
Title
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
Description
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
Description
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
Time Frame
3 months post treatment
Title
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
Description
The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past month (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely).
Time Frame
6 months post treatment
Title
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
Description
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Time Frame
Baseline
Title
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
Description
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Time Frame
before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
Title
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
Description
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Time Frame
end of treatment(Upto 16 weeks from start of treatment)
Title
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
Description
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Time Frame
3 months post treatment
Title
Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
Description
The BDI is a 21-item self-report rating inventory that is rated in a 4 point scale from 0-3 based in severity with a maximum score if 63.
Time Frame
6 months post treatment
Title
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Time Frame
Baseline
Title
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Time Frame
before every session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
Title
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Time Frame
3 months post treatment
Title
Severity of depression as assessed by the Quick Inventory of Depression Symptomatology (QIDS) The QIDS is a 16-item measure that is scored on a 4 point scale from 0-3 with a higher number indicating more severity of depression.
Time Frame
6 months post treatment
Title
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
Description
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Time Frame
Baseline
Title
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
Description
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
Description
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Time Frame
3 months post treatment
Title
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
Description
BSSI is a 21-item self-report measure that is scored on a 3 point scale from 0-2 with a higher number indicting a greater suicidal ideation
Time Frame
6 months post treatment
Title
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Time Frame
Baseline
Title
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Time Frame
3 months post-treatment
Title
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
Time Frame
6 months post-treatment
Title
Number of patients with anxiety, mood, psychotic, substance, and eating disorders as assessed by the MINI International Neuropsychiatric Interview (MINI)
Time Frame
Baseline
Title
Extent to which client was satisfied with the training as assessed by the Client Satisfaction Questionnaire (CSQ)
Description
The CSQ is an 8-item measure of client satisfaction rated on a 1-4 point Likert scale. A higher score indicates a higher satisfaction.
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
Feedback form participants as assessed by the Qualitative interview(QI) which will include a series of open ended questions aimed at eliciting feedback from participants about their perspective on the PE-CLASP Intervention
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Secondary Outcome Measure Information:
Title
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
Description
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Time Frame
Baseline
Title
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
Description
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Time Frame
end of treatment (Upto 16 weeks from start of treatment)
Title
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
Description
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Time Frame
3 months post treatment
Title
Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
Description
The LEC-5 assesses exposure to 16 events known to potentially result in PTSD or distress and includes one additional item assessing any other extraordinarily stressful event not captured in the first 16 items. For each potentially traumatic life event, respondents rate their experience of that event on a 6-point nominal scale (1 = happened to me, 2 = witnessed it, 3 = learned about it, 4 = part of my job, 5 = not sure, and 6 = doesn't apply). The LEC-5 does not yield a total score or composite score.
Time Frame
6 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to read and write in English. This is essential in order to complete the informed consent, self-report questionnaires, and homework assignments for the study. Diagnosis of PTSD according to the Clinician Administered PTSD Scale (CAPS). This is essential for the aims of the study, which include primarily to demonstrate a reduction in PTSD-related distress and ultimately in suicidal behaviors and thoughts. Suicidal ideation (SI) with a plan and/or a history of suicide attempts (SA). This is essential for the aims of the study, which include primarily to demonstrate a reduction in suicidal behaviors and thoughts as well as in PTSD related distress. Active duty service member Willingness to sign a release of information to allow for continuous communication between research study staff and treatment providers or between the research study staff and external mental health providers in order to ensure that any important information between the patient and their care team can be shared openly between the participating center and research staff involved in the patients care or assessment. Exclusion Criteria: Current psychotic or manic episode as indicated by the MINI International Neuropsychiatric Interview. While it is possible that the intervention may be effective in individuals with psychosis, the research community needs to demonstrate the overall success of the intervention before it is applied to specialized subgroups, like individuals with psychosis. The intervention may also be eventually useful for individuals with a bipolar illness(defined by the presence of manic episodes) but likely that would require stabilization of mania prior to intervention implementation. As such these individuals will be excluded from the current study, though should possibly be included in future research depending on the results of the study. Current substance use disorder, severe (in the past terminology "dependence") that would preclude the ability to focus on PTSD and suicide symptom reduction. As with key exclusion criterion above, it is possible that individuals with a principal substance use disorder diagnosis may benefit from the intervention. However, the research community needs to demonstrate the overall success of the intervention (including in individuals with comorbid, but not principal) substance use disorders before it is applied in those with a principal substance use disorder. Current alternative evidence-based PTSD or suicide-focused individual psychotherapy, including current individual weekly Prolonged Exposure, current individual weekly Cognitive Processing Therapy, and current individual Coping LongTerm with Active Suicide Program (CLASP). Active involvement in an evidence-based PTSD or suicide-focused therapy would preclude the ability to scientifically test the effect of the intervention.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Acierno, PhD
Phone
(713) 486-2863
Email
Ronald.Acierno@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel J Murphy
Email
Daniel.J.Murphy@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Acierno, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Acierno, PhD
Phone
713-486-2863
Email
Ronald.Acierno@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Daniel J Murphy
Phone
(713) 486-2841
Email
Daniel.J.Murphy@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Integration of PE & Coping Long-Term With Active Suicide Program for PTSD & Suicide Risk in Military Families

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