Trial Outcomes & Findings for Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans (NCT NCT01510834)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

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

Results posted on

2017-12-07

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	90
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Computerized Tailored Intervention for Behavioral Sequelae of PTSD in Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=90 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42.4 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants

PRIMARY outcome

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

Population: 57 completing all time points for intervention and assessment.

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.

Outcome measures

Outcome measures
Measure	Mean Difference in PCL (T1, T3) (Negative Change is Better) n=57 Participants Mean difference in PCL (T1, T3) for study completers
Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)	-6.82456 units on a scale Standard Deviation 14.1486

SECONDARY outcome

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

Population: Participants completing all 3 study time points.

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.

Outcome measures

Outcome measures
Measure	Mean Difference in PCL (T1, T3) (Negative Change is Better) n=57 Participants Mean difference in PCL (T1, T3) for study completers
Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)	7.08772 units on a scale Standard Deviation 15.73132

SECONDARY outcome

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

Population: All participants completing all 3 time points of the study.

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.

Outcome measures

Outcome measures
Measure	Mean Difference in PCL (T1, T3) (Negative Change is Better) n=57 Participants Mean difference in PCL (T1, T3) for study completers
Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)	-3.78 units on a scale Standard Deviation 7.79

SECONDARY outcome

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

Population: Those participants who completed all 3 time points.

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.

Outcome measures

Outcome measures
Measure	Mean Difference in PCL (T1, T3) (Negative Change is Better) n=57 Participants Mean difference in PCL (T1, T3) for study completers
Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)	-2.08772 units on a scale Standard Deviation 6.26863

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laurel King, PhD

Pacific Health Research and Education Institute

Phone: 808-564-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place