Clinical trial NCT04284410: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Suicidal Ideation
Keywords: depression
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
timeFrame: Baseline
measure: 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)
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: 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)
timeFrame: 3 months post treatment
measure: 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)
timeFrame: 6 months post treatment
measure: The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
timeFrame: Baseline
measure: The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
timeFrame: before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
measure: The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
timeFrame: 3 months post treatment
measure: The extent to which participants have been bothered by PTSD symptoms as assessed by the PTSD Checklist for DSM-5 (PCL-5) assessment.
timeFrame: 6 months post treatment
measure: Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
timeFrame: Baseline
measure: Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
timeFrame: before each session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
measure: Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
timeFrame: end of treatment(Upto 16 weeks from start of treatment)
measure: Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
timeFrame: 3 months post treatment
measure: Number of patients with characteristic attitudes and symptoms of depression as measured by the Black depression Inventory (BDI)
timeFrame: 6 months post treatment
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: before every session(participants will complete 8-16 weekly or twice weekly individual therapy sessions)
measure: 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.
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: 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.
timeFrame: 3 months post treatment
measure: 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.
timeFrame: 6 months post treatment
measure: Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
timeFrame: Baseline
measure: Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
timeFrame: 3 months post treatment
measure: Intensity of attitudes, behaviors and plans to commit suicide over the prior week as assessed by the Beck Scale for Suicidal ideation(BSSI)
timeFrame: 6 months post treatment
measure: Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline
measure: Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 3 months post-treatment
measure: Measure of suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: 6 months post-treatment
measure: Number of patients with anxiety, mood, psychotic, substance, and eating disorders as assessed by the MINI International Neuropsychiatric Interview (MINI)
timeFrame: Baseline
measure: Extent to which client was satisfied with the training as assessed by the Client Satisfaction Questionnaire (CSQ)
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: 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
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
Secondary outcomes:
measure: Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
timeFrame: Baseline
measure: Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
timeFrame: end of treatment (Upto 16 weeks from start of treatment)
measure: Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
timeFrame: 3 months post treatment
measure: Number of potentially traumatic events in a respondent's lifetime as assessed by The Life Events Checklist for DSM-5 (LEC-5).
timeFrame: 6 months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ronald Acierno, PhD
role: PRINCIPAL_INVESTIGATOR
References: