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

This study has been completed.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
Pro-Change Behavior Systems
University of Hawaii
Information provided by (Responsible Party):
James Spira, VA Pacific Islands Health Care System
ClinicalTrials.gov Identifier:
NCT01510834
First received: October 7, 2011
Last updated: July 2, 2013
Last verified: July 2013
Results First Received: March 5, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Post Traumatic Stress Disorder
Smoking
Anxiety
Depression
Intervention: Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from July 22, 2011-November 30, 2011. Recruitment was accomplished through targeted mailings to VA patients at risk for PTSD; study flyers at VA mental health providers; and social media networks to target veterans. Pre-screening, consenting, assessments, enrollment, and intervention were done completely online.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
To minimize participant risk, secondary screening excluded veterans who did not meet risk criteria for mild to moderate PTSD (score <25 or >73 on the PCL-M), or had severe depression (scoring ≥20 on the PHQ-8). 354 veterans registered on the site, 95 did not complete screening; 169 screened out; 90 completed baseline assessments.

Reporting Groups
  Description
All 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.

Participant Flow:   Overall Study
    All Participants  
STARTED     90  
COMPLETED     57  
NOT COMPLETED     33  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All 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.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  90  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     90  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  42.4  ± -11.3  
Gender  
[units: participants]
 
Female     22  
Male     68  
Region of Enrollment  
[units: participants]
 
United States     90  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)   [ Time Frame: Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3) ]

3.  Secondary:   Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)   [ Time Frame: Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3) ]

4.  Secondary:   Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)   [ Time Frame: Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
N.A.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Laurel King, PhD
Organization: Pacific Health Research and Education Institute
phone: 808-564-5711
e-mail: laurel.king@va.gov


No publications provided


Responsible Party: James Spira, VA Pacific Islands Health Care System
ClinicalTrials.gov Identifier: NCT01510834     History of Changes
Other Study ID Numbers: 2009-04/JLS 0002, W81XWH-09-2-0106
Study First Received: October 7, 2011
Results First Received: March 5, 2013
Last Updated: July 2, 2013
Health Authority: United States: Federal Government