N/A
N=90
Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans
Post Traumatic Stress Disorder · Smoking · Anxiety · Depression
Bottom Line
View on ClinicalTrials.gov: NCT01510834 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993) — -6.82456 units on a scale — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multibehavioral, Computerized Tailored Intervention STR2IVE (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Pacific Islands Health Care System
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993) |
-6.82456 | .001 sig |
| SECONDARY Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982) |
7.08772 | .001 sig |
| SECONDARY Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983) |
-3.78 | <.001 sig |
| SECONDARY Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999) |
-2.08772 | .015 sig |
Summary
This project assesses the usability and feasibility of a multi-behavioral computerized, tailored intervention (CTI) or expert system delivered via the Internet for veterans with Post-Traumatic Stress symptoms. Three behavioral health risk factors, (1) smoking, (2) depression, and (3) stress, that are associated with Post-Traumatic Stress Disorder (PTSD), are included in the Computerized, Tailored Intervention (CTI) system. The project adapts and modifies an existing CTI system built on the Transtheoretical Model of Behavior Change (TTM) to make it relevant to a veteran population. The system has been successfully utilized with general adult populations. The study utilizes methods that are characteristic of a product development project. Each of the four project phases are sequential and build upon the results of the previous phase. Phase 1 focuses on the review of current CTI programs on smoking cessation, stress management, and depression prevention, and integrating them into a multi-behavioral program for application with veterans. Phase 2 includes the development and adaptation of text-based feedback messages and multimedia components for smoking cessation, stress management, and depression prevention for veterans. Initial testing of the modified CTI programs commences in Phase 3. Cognitive and usability testing with veterans are performed, and additional modifications to the behavioral modules are made based on the test results. Phase 4 focuses on a feasibility study to test the multi-behavioral CTI system with veterans online.
Eligibility Criteria
Inclusion Criteria
- Military Veterans, Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) service preferred
- 18 years or older
- Ability to read and comprehend English
- Mild to moderate PTSD symptoms
- Cigarette smoking (preferred)
- Mild to moderate depression (preferred)
- Difficulty managing stress
- Comfortable using a computer and access to the Internet
Exclusion Criteria
- Present with psychosis, bipolar disorder, active substance use, or cognitive impairment
- Severe depression or suicidal ideation (Patient Health Questionnaire-9)(PHQ-9 >19)
- Severe PTSD symptoms (PTSD Symptom Checklist)(PCL-M >73)
Data sourced from ClinicalTrials.gov (NCT01510834). 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.