Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans - Full Text View

Purpose

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. 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.

Condition	Intervention
Post Traumatic Stress Disorder Smoking Anxiety Depression	Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Computerized Tailored Intervention for Behavioral Sequelae of Post-Traumatic Stress Disorder in Veterans

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Post-Traumatic Stress Disorder Quitting Smoking Smoking

U.S. FDA Resources

Further study details as provided by VA Pacific Islands Health Care System:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Quality of Life Scale ([QOLS], Flanagan, 1978, 1982) [ Time Frame: Baseline; 30-60 days; and 90-120 days ] [ Designated as safety issue: No ]
The QOLS contains 16 items that represent five conceptual domains of quality of life. QOLS was developed with more consideration to cultural diversity and individual perspectives than other commonly used measures. It uses a unique 7-item Likert scale that allows responses regarding different aspects of life to range from "delightful" to "terrible". Both the original 15-item QOLS satisfaction scale and the 16-item version used in this study were found to be internally consistent with alpha from .82 to .92 and showed high test-retest reliability over 3-weeks (r = 0.78 to r = 0 .84).
The Perceived Stress Scale ([PSS] Cohen, Kamarck, & Mermelstein, 1983) [ Time Frame: Baseline; 30-60 days; and 90-120 days ] [ Designated as safety issue: No ]
The PSS is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in the past month. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are of a general nature and relatively free of content specific to any subpopulation. Internal consistency reliability of the PSS is moderate (Cronbach alpha coefficient =.78) and it has good test-re-test reliability.
Patient Health Questionnaire ([PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999) [ Time Frame: Baseline; 30-60 days; and 90-120 days ] [ Designated as safety issue: No ]
The PHQ-9 is the self-administered depression module of the Patient Health Questionnaire that assesses common mental disorders. Eight of the 9 items in the scale are included in the Depression Prevention Assessment and is also known as the PHQ-8. Item 9, which assesses suicidality has been omitted in the online version. The PHQ-8 has a sensitivity of 81% and specificity of 99% for scores 15 and above in diagnosing major depression, with a positive predictive value of 94%.

Estimated Enrollment:	90
Study Start Date:	July 2011
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Intervention Details:

All Participants are provided with the same multibehavioral CTI system and must choose two or three behavior programs to complete (smoking cessation, stress management, and/or depression prevention). They are asked to complete an assessment and 2 behavior programs at baseline, 30-days, and 90-days. They are 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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Military Veterans, OIF/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 (PHQ-9 >19)
Severe PTSD symptoms (PCL-M >73)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510834

Locations

United States, Hawaii
VA Pacific Island Health Care System
Honolulu, Hawaii, United States, 96819

Sponsors and Collaborators

VA Pacific Islands Health Care System

U.S. Army Medical Research and Materiel Command

Pro-Change Behavior Systems

University of Hawaii

Investigators

Principal Investigator:

James L Spira, Ph.D.

National Center for PTSD Pacific Islands Division

More Information

No publications provided

Responsible Party:	James Spira, Director, National Center for PTSD Pacific Islands Division, VA Pacific Islands Health Care System
ClinicalTrials.gov Identifier:	NCT01510834 History of Changes
Other Study ID Numbers:	2009-04/JLS 0002
Study First Received:	October 7, 2011
Last Updated:	January 13, 2012
Health Authority:	United States: Federal Government

Keywords provided by VA Pacific Islands Health Care System:

Computerized Tailored Intervention
CTI
Post Traumatic Stress Disorder
PTSD

Smoking
Anxiety
Depression

Additional relevant MeSH terms:

Anxiety Disorders
Depression
Depressive Disorder
Smoking
Stress Disorders, Post-Traumatic

Stress Disorders, Traumatic
Mental Disorders
Behavioral Symptoms
Mood Disorders
Habits

ClinicalTrials.gov processed this record on May 22, 2013

Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans (CTI)