Phase 2
N=33
IOK Treatment Study
Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01605799 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Change in PTSD Symptoms as Measured by the PCL — -7.33; -2.13 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IOK Killing Treatment (Behavioral); Wait list control group (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Symptoms as Measured by the PCL |
-7.33; -2.13 | — |
| SECONDARY Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53) |
-17.73; 4.53 | — |
Summary
The goals of this project are
* 1) to evaluate the effectiveness of a CBT treatment module addressing the mental health and functional impact of killing in the war zone,
* 2) to gather data on Veteran stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to further refine the intervention, and
* 3) to gather data on clinician stakeholders' perceptions of acceptability and feasibility of the CBT treatment module, which would be used to ensure that the module could be easily integrated into EBT for PTSD.
Eligibility Criteria
Inclusion Criteria
- Combat Veterans ranging in age from 18-70 years will be recruited to participate in this study. Combat veterans ranging in age from 70 to 90 years will also be considered for enrollment in the study on a case-by-case basis.
- Veterans will need to endorse having taken a life in a war zone context, to meet criteria for PTSD, and to have received some prior treatment for PTSD to be included in the study.
- Participants in current PTSD treatment will not be excluded; however, if receiving medications, they will need to be stabilized on current medications for at least one month.
- If receiving Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), the two treatments the VA recognizes as evidence-based treatment for PTSD, individuals will need to wait two weeks after they have completed the treatment in order to enroll in the study, and new baseline measures will be obtained at that time.
Exclusion Criteria
- Potential participants will only be excluded if they meet current or lifetime criteria for a psychotic disorder.
Data sourced from ClinicalTrials.gov (NCT01605799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.