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

The University of Texas System (UT)

Status

Withdrawn

Conditions

Suicidal Ideation

Post Traumatic Stress Disorder

Treatments

Behavioral: CLASP-PE arm

Study type

Interventional

Funder types

Other

Identifiers

NCT04284410

HSC-MS-19-1067

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.