Trial Outcomes & Findings for Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans (NCT NCT01984515)

NCT ID: NCT01984515

Last Updated: 2015-12-16

Results Overview

Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: From initiation of the Referral Management System to 6 months after initiation
• Results posted on: 2015-12-16

Participant Flow

Participant milestones

Measure	Team Red Primary Care Eligible patients will receive the Referral Management System in primary care Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.
Overall Study STARTED	59
Overall Study Received CBT Session	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans

Baseline characteristics by cohort

Measure	Team Red Primary Care n=40 Participants Eligible patients will receive the Referral Management System in primary care Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.
Age, Continuous	47 years STANDARD_DEVIATION 15 • n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	37 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	35 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	40 participants n=93 Participants

PRIMARY outcome

Timeframe: From initiation of the Referral Management System to 6 months after initiation

Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.

Outcome measures

Measure

Team Red Primary Care n=40 Participants Eligible patients will receive the Referral Management System in primary care Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.

Engagement in Evidence-based Psychotherapy for PTSD

40 participants

SECONDARY outcome

Timeframe: Referral Management Initiation, 1 month post initiation, 3 months post initiation

Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.

Outcome measures

Measure	Team Red Primary Care n=40 Participants Eligible patients will receive the Referral Management System in primary care Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.
PTSD Checklist-Specific 1 month post initiation	59 units on a scale Standard Deviation 9
PTSD Checklist-Specific RMS initiation	64 units on a scale Standard Deviation 10
PTSD Checklist-Specific 3 months post initiation	59 units on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: Referral Management Initiation, 1 month post initiation, 3 months post initiation

9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.

Outcome measures

Measure	Team Red Primary Care n=40 Participants Eligible patients will receive the Referral Management System in primary care Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.
Patient Health Questionnaire-9 Item RMS initiation	16 units on a scale Standard Deviation 5
Patient Health Questionnaire-9 Item 1 month post RMS initiation	14 units on a scale Standard Deviation 4
Patient Health Questionnaire-9 Item 3 months post RMS initiation	14 units on a scale Standard Deviation 5

Adverse Events

Team Red Primary Care

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

Dr. Kyle Possemato

Center for Integrated Healthcare

Phone: 315-425-4400

Email: kyle.possemato@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place