Integration of Prolonged Exposure (PE) and Coping Long-Term With Active Suicide Program (CLASP) for PTSD and Suicide Risk in Military Families
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of patients with anxiety, mood, psychotic, substance, and eating disorders as assessed by the MINI International Neuropsychiatric Interview (MINI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CLASP-PE arm
干预措施: CLASP-PE arm (Behavioral)
结局指标
主要结局
Number of patients with anxiety, mood, psychotic, substance, and eating disorders as assessed by the MINI International Neuropsychiatric Interview (MINI)
时间窗: Baseline
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.
时间窗: 6 months post treatment
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
时间窗: 6 months post treatment
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
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)
时间窗: 6 months post treatment
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 patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
时间窗: 6 months post treatment
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.
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
时间窗: 6 months post treatment
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).
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
时间窗: end of treatment (Upto 16 weeks from start of treatment)
Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 6 months post-treatment
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.
Extent to which client was satisfied with the training as assessed by the Client Satisfaction Questionnaire (CSQ)
时间窗: end of treatment (Upto 16 weeks from start of treatment)
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.
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.
时间窗: Baseline
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)
时间窗: Baseline
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)
时间窗: end of treatment (Upto 16 weeks from start of treatment)
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)
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.
时间窗: before every session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
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)
时间窗: 3 months post treatment
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.
时间窗: Baseline
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.
时间窗: before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
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.
时间窗: end of treatment (Upto 16 weeks from start of treatment)
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).
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.
时间窗: end of treatment (Upto 16 weeks from start of treatment)
The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
时间窗: 3 months post treatment
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)
时间窗: Baseline
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)
时间窗: before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
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)
时间窗: end of treatment(Upto 16 weeks from start of treatment)
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)
时间窗: 3 months post treatment
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.
时间窗: 3 months post treatment
Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
时间窗: Baseline
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)
时间窗: end of treatment (Upto 16 weeks from start of treatment)
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)
时间窗: 3 months post treatment
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)
时间窗: Baseline
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)
时间窗: end of treatment (Upto 16 weeks from start of treatment)
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)
时间窗: 3 months post-treatment
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.
次要结局
- Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).(6 months post treatment)
- Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).(Baseline)
- Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).(end of treatment (Upto 16 weeks from start of treatment))
- Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).(3 months post treatment)
研究者
Ronald E. Acierno
Visiting Professor
The University of Texas Health Science Center, Houston