Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans (CTI-PTSD)
|ClinicalTrials.gov Identifier: NCT01510834|
Recruitment Status : Completed
First Posted : January 18, 2012
Results First Posted : July 4, 2013
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Smoking Anxiety Depression||Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Computerized Tailored Intervention for Behavioral Sequelae of Post-Traumatic Stress Disorder in Veterans|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||October 2012|
Experimental: 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.
Behavioral: 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.
- 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) ]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 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) ]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". It has been 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 QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Previous validation research showed that patients who participated in a treatment program and rated their symptoms as improved by 60% or gained on average 7 to 8 points on the QOLS total score. A higher QOLS score indicates better quality of life, therefore, a positive score change is a better outcome.
- 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) ]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 has been shown to be moderate (Cronbach alpha coefficient =.78) and that it has good test-re-test reliability. Scores can range from 0-40 as items are scored 0-4 points each. A higher score indicates more stress, so a negative change from baseline (T1)to 3-month follow-up (T3) is a better outcome.
- 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) ]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 been shown to have a sensitivity of 81% and specificity of 99% for scores 15 and above in diagnosing major depression, with a positive predictive value of 94%. Scores range from 0 to 24 (0-3 points per question multiplied by 8 questions), with 0-9 indicating no depression, 10-14 minor depression, 15-19 moderately severe major depression, and >19 indicating sever major depression. An initial drop of 5 points is considered adequate treatment response for 3 counseling sessions over 4-6 weeks. A higher score indicates more depression, so a reduction in score from baseline (T1) to 3-month follow-up (T3) is a better outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510834
|United States, Hawaii|
|VA Pacific Island Health Care System|
|Honolulu, Hawaii, United States, 96819|
|Dept of Public Health, John A. Burns School of Medicine, University of Hawaii at Manoa|
|Honolulu, Hawaii, United States, 96822|
|United States, Rhode Island|
|Pro-Change Behavioral Systems, Inc.|
|Kingston, Rhode Island, United States, 02892|
|Principal Investigator:||James L Spira, Ph.D.||National Center for PTSD Pacific Islands Division|