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

• Sponsor: VA Pacific Islands Health Care System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01510834
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed), Pro-Change Behavior Systems (Other), University of Hawaii (Other)
• Enrollment: 90
• Locations: 3
• Arm: 1
• Duration (Months): 15
• Patients Per Site: 30
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder; Smoking; Anxiety; Depression	Behavioral: Multibehavioral, Computerized Tailored Intervention STR2IVE	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: N/A
• 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: Jul 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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)]

   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.

2. 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)]

   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.

3. 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)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Pacific Island Health Care System	Honolulu	Hawaii	United States	96819
2	Dept of Public Health, John A. Burns School of Medicine, University of Hawaii at Manoa	Honolulu	Hawaii	United States	96822
3	Pro-Change Behavioral Systems, Inc.	Kingston	Rhode Island	United States	02892

Sponsors and Collaborators

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

Investigators

• Principal Investigator: James L Spira, Ph.D., National Center for PTSD Pacific Islands Division

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: VA Pacific Islands Health Care System
• ClinicalTrials.gov Identifier: NCT01510834
• Other Study ID Numbers: 2009-04/JLS 0002; W81XWH-09-2-0106
• First Posted: Jan 18, 2012
• Last Update Posted: Dec 7, 2017
• Last Verified: Jul 1, 2013

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Recruitment Details	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 Detail	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.

Arm/Group Title	All Participants
Arm/Group Description	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.
Period Title: Overall Study
STARTED	90
COMPLETED	57
NOT COMPLETED	33

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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.
Overall Participants	90
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	90 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.4 (11.3)
Sex: Female, Male (Count of Participants)
Female	22 24.4%
Male	68 75.6%
Region of Enrollment (participants) [Number]
United States	90 100%

Outcome Measures

1. Primary Outcome

Title	Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)
Description	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.
Time Frame	Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)

Outcome Measure Data

Analysis Population Description

57 completing all time points for intervention and assessment.

Arm/Group Title	Mean Difference in PCL (T1, T3) (Negative Change is Better)
Arm/Group Description	Mean difference in PCL (T1, T3) for study completers
Measure Participants	57
Mean (Standard Deviation) [units on a scale]	-6.82456 (14.1486)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mean Difference in PCL (T1, T3) (Negative Change is Better)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.824
	Confidence Interval	(2-Sided) 95%; -10.578 to -3.070
	Parameter Dispersion	Type: Standard Deviation; Value: 14.148
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants completing all 3 study time points.

Arm/Group Title	Mean Difference in QOLS (T1, T3)
Arm/Group Description	Mean Difference in QOLS (T1, T3)for study completers only
Measure Participants	57
Mean (Standard Deviation) [units on a scale]	7.08772 (15.73132)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mean Difference in PCL (T1, T3) (Negative Change is Better)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.0872
	Confidence Interval	(2-Sided) 95%; 2.91 to 11.26
	Parameter Dispersion	Type: Standard Deviation; Value: 15.731
	Estimation Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All participants completing all 3 time points of the study.

Arm/Group Title	Mean Difference in PSS (T1, T3)
Arm/Group Description	Mean difference in Perceived Stress Scale (T1, T3) for study completers
Measure Participants	57
Mean (Standard Deviation) [units on a scale]	-3.78 (7.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mean Difference in PCL (T1, T3) (Negative Change is Better)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.78
	Confidence Interval	(2-Sided) 95%; -5.84 to -1.70
	Parameter Dispersion	Type: Standard Deviation; Value: 7.78
	Estimation Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Those participants who completed all 3 time points.

Arm/Group Title	Mean Difference in PHQ-8 (T1, T3)
Arm/Group Description	Mean Difference in PHQ-8 (T1,T3) for study completers
Measure Participants	57
Mean (Standard Deviation) [units on a scale]	-2.08772 (6.26863)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mean Difference in PCL (T1, T3) (Negative Change is Better)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.015
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.08
	Confidence Interval	(2-Sided) 95%; -3.751 to -.4244
	Parameter Dispersion	Type: Standard Deviation; Value: 6.269
	Estimation Comments

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	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.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/90 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/90 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.