Clinical trial NCT01510834: Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans
Official title: Computerized Tailored Intervention for Behavioral Sequelae of Post-Traumatic Stress Disorder in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Smoking
Anxiety
Depression
Keywords: Computerized Tailored Intervention
CTI
Post Traumatic Stress Disorder
PTSD
Smoking
Anxiety
Depression
Lead sponsor: VA Pacific Islands Health Care System
Sponsor class: FED
Collaborators: name: U.S. Army Medical Research and Development Command
name: Pro-Change Behavior Systems
name: University of Hawaii
First posted: 2012-01-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)
timeFrame: Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)
Secondary outcomes:
measure: Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)
timeFrame: Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3)
measure: Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)
timeFrame: Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3)
measure: Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)
timeFrame: Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3)
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: VA Pacific Island Health Care System
state: Hawaii
city: Honolulu
country: United States
facility: Dept of Public Health, John A. Burns School of Medicine, University of Hawaii at Manoa
state: Hawaii
city: Kingston
country: United States
facility: Pro-Change Behavioral Systems, Inc.
state: Rhode Island
Study officials:
affiliation: National Center for PTSD Pacific Islands Division
name: James L Spira, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jordan PJ, Evers KE, Burke KY, King LA, Nigg CR. A computerized, tailored intervention to address behaviors associated with PTSD in veterans: rationale and design of STR(2)IVE. Transl Behav Med. 2011 Dec;1(4):595-603. doi: 10.1007/s13142-011-0088-1.