Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans

NCT01510834 | Completed Results

• 2 other identifiers: 2009-04/JLS 0002W81XWH-09-2-0106
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Traumatic Stress Disorder; Smoking; Anxiety; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)

  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.

  Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)

Secondary Outcomes (3)

• Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)

  Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3)

• Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)

  Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3)

• Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)

  Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3)

Study Arms (1)

All STR2IVE Participants

EXPERIMENTAL

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.

Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE

Interventions

Multibehavioral, Computerized Tailored Intervention STR2IVE 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.

All STR2IVE Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Military Veterans, Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) service preferred
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Pacific Islands Health Care System: lead
• U.S. Army Medical Research and Development Command: collaborator
• Pro-Change Behavior Systems: collaborator
• University of Hawaii: collaborator

Study Sites (3)

VA Pacific Island Health Care System

Honolulu, Hawaii, 96819, United States

Location

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

Honolulu, Hawaii, 96822, United States

Location

Pro-Change Behavioral Systems, Inc.

Kingston, Rhode Island, 02892, United States

Location

Related Publications (1)

• 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.

  PMID: 24073082 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Smoking; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior; Behavioral Symptoms

Results Point of Contact

• Title: Laurel King, PhD
• Organization: Pacific Health Research and Education Institute

laurel.king@va.gov

808-564-5711

Study Officials

• James L Spira, Ph.D.

  National Center for PTSD Pacific Islands Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: January 18, 2012
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 7, 2017
• Results First Posted: July 4, 2013

Record last verified: 2013-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)