Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans

NCT ID: NCT01510834

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-10-31

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.

Conditions

Post Traumatic Stress Disorder; Smoking; Anxiety; Depression

Keywords

Computerized Tailored Intervention; CTI; Post Traumatic Stress Disorder; PTSD; Smoking; Anxiety; Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Multibehavioral, Computerized Tailored Intervention STR2IVE

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Pro-Change Behavior Systems

OTHER

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: collaborator

VA Pacific Islands Health Care System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James L Spira, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Center for PTSD Pacific Islands Division

Locations

VA Pacific Island Health Care System

Honolulu, Hawaii, United States

Dept of Public Health, John A. Burns School of Medicine, University of Hawaii at Manoa

Honolulu, Hawaii, United States

Pro-Change Behavioral Systems, Inc.

Kingston, Rhode Island, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24073082 (View on PubMed)

Other Identifiers

W81XWH-09-2-0106

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-04/JLS 0002

Identifier Type: -

Identifier Source: org_study_id