Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans (CTI-PTSD)
|First Received Date ICMJE||October 7, 2011|
|Last Updated Date||July 2, 2013|
|Start Date ICMJE||July 2011|
|Primary Completion Date||March 2012 (final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993) [ Time Frame: Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3) ] [ Designated as safety issue: No ]
Developed by researchers at the VA National Center for PTSD, PCL is a self-report questionnaire that consists of 17 questions that map directly onto DSM-IV criteria for PTSD. Respondents are asked how often they have been bothered by each symptom in the past month on a 5-point Likert scale (1=not at all to 5=extremely). Previous research has shown internal consistency coefficients were high for the total scale (.97) and for each subscale (.92 - .93). Test-retest reliability over 2-3 days was shown to be .96. Scores can range from 17-85, with a score of 48 typically indicating PTSD in military populations. The National Center for PTSD recommends using 5 points as a minimum threshold for determining whether an individual has responded to treatment and 10 points as a minimum threshold for determining whether the improvement is clinically meaningful. A higher score indicates more PTSD symptoms, therefore, a score reduction from T1 to T3 is a better outcome than an increase.
|Original Primary Outcome Measures ICMJE
||PTSD Symptom Checklist-Military ([PCL-M], Weathers et al., 1993) [ Time Frame: Change in PCL-M from baseline/30-60 day follow-ups, to that measured at final follow-up (90-120 days) ] [ Designated as safety issue: No ]
Developed by researchers at the VA National Center for PTSD, PCL is a self-report questionnaire that consists of 17 questions that map directly onto DSM-IV criteria for PTSD. Respondents are asked how often they have been bothered by each symptom in the past month on a 5-point Likert scale (1=not at all to 5=extremely). Internal consistency coefficients were high for the total scale (.97) and for each subscale (.92 - .93). Test-retest reliability over 2-3 days was .96.
|Change History||Complete list of historical versions of study NCT01510834 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans|
|Official Title ICMJE||Computerized Tailored Intervention for Behavioral Sequelae of Post-Traumatic Stress Disorder in Veterans|
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.
This proof of concept project develops and pilot tests a viable Internet-based intervention to assist veterans with Post-Traumatic Stress symptoms to progress toward changing negative health behaviors that are associated with PTSD and are often difficult to change. Most commercially available CTIs and software applications have limited impact, because of the lack of theory-driven material and empiricism. The proposed CTI is supported by more than 30 years of scientific evidence, and uses the Transtheoretical Model of Behavior Change (TTM) as the theoretical basis for generating personalized interventions (Prochaska & Velicer, 1997; Velicer, Prochaska, & Redding, 2006). The TTM is ideally suited to those who are resistant to change and unlikely to take action in the near future, as well as those prone to relapse.
The intervention will be primarily targeted at negative coping strategies that confound or exacerbate Post-Traumatic Stress symptoms and hinder progress toward remission. Progress in a Transtheoretical Model of Behavior Change (TTM) conceptual framework may be defined as movement from one TTM stage of change to the next level of the change process, rather than the elimination or significant reduction of smoking, depression, or stress per se. The CTI system that will be modified during this project has been empirically tested and validated with a general population and has demonstrated significant outcomes for the three proposed modules — smoking cessation, depression prevention, and stress management. The CTI system provides an intervention that emphasizes advancement through the processes of change at one's own pace as the focus of project, rather than the linear progression through a structured behavior change program to achieve changes in the undesired behaviors.
Hypothesis 1: The structure and TTM-based content of the adapted Smoking Cessation, Depression Prevention, and Stress Management systems and consequent CTI will be appropriate for veterans.
Primary Aim 1: To modify TTM-based Smoking Cessation, Depression Prevention, and Stress Management behavioral intervention modules, originally developed for general adult populations, to be appropriate and relevant for veterans with Post-Traumatic Stress symptoms.
Secondary Aim 1a: To conceptualize the CTI program's approach, content, and design based on input from a diverse sample of military veterans and expert consultants.
Hypothesis 2: A multi-behavioral CTI can be successfully implemented with veterans who have Post-Traumatic Stress symptoms
Primary Aim 2: To demonstrate that a multi-behavioral CTI can be successfully implemented with veterans with Post-Traumatic Stress symptoms.
Secondary Aim 2a: To conduct usability interviews with veterans to ensure that the target population can navigate through the computerized intervention and understand the intervention content.
Secondary Aim 2b: To demonstrate the feasibility of CTI by: a) recruiting veterans to the project and delivery of the proposed intervention; and b) assessing the acceptability and perceived usefulness of the intervention from the perspective of veterans with Post-Traumatic Stress symptoms.
Secondary Aim 2c: To demonstrate feasibility of CTI to increase motivation to change targeted behaviors, i.e., smoking cessation, depression prevention, and stress management.
Secondary Aim 2d: To demonstrate positive change in assessment outcomes for Post-Traumatic Stress symptoms, depression, quality of life, and perceived stress.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Intervention ICMJE||Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE
All participants were provided with the same multibehavioral CTI system and chose two or three behavior programs to complete (smoking cessation, stress management, and/or depression prevention)monthly. They were asked to complete an assessments at baseline, 30-days, and 90-days. They were allowed to access the system workbook anytime but they must wait a minimum of 25 days between assessments and programs at time points 1 and 2, and 55 days between time points 2 and 3.
|Study Arm (s)||Experimental: All STR2IVE Participants
All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month. Behavioral programs and assessments were provided online via the Multibehavioral, Computerized Tailored Intervention STR2IVE.
Intervention: Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||October 2012|
|Primary Completion Date||March 2012 (final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01510834|
|Other Study ID Numbers ICMJE||2009-04/JLS 0002, W81XWH-09-2-0106|
|Has Data Monitoring Committee||No|
|Responsible Party||James Spira, VA Pacific Islands Health Care System|
|Study Sponsor ICMJE||VA Pacific Islands Health Care System|
|Information Provided By||VA Pacific Islands Health Care System|
|Verification Date||July 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP