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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CLASP-PE arm
  • Behavioral: CLASP-PE arm
    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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Ronald Acierno, PhD
713-486-2863
Ronald.Acierno@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Ronald Acierno, PhD
(713) 486-2863
Ronald.Acierno@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.