Trial Outcomes & Findings for Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees (NCT NCT03711266)

Results Overview

The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores ≥ 33 indicate a probable diagnosis of PTSD. Data presented represent a change from baseline PCL-5 assessment to the 4-month PCL-5 assessment (e.g., value at baseline minus value at 4 months).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline, 4-months

Results posted on

2022-02-18

Participant Flow

We aimed to recruit 40-50 patients. However, due to FQHC constraints during the COVID-19 pandemic, we were only able to recruit 35 patients.

Thirty-five patients were enrolled; however, five were removed by the study therapist prior to intervention initiation and were not included in the final analysis. Three of these patients had a comorbid condition requiring a higher level of care (active psychotic symptoms; severe emotion dysregulation), one was deemed to be at high risk for suicide, and one did not meet diagnostic criteria for PTSD.

Participant milestones

Participant milestones
Measure	PE-PC Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Overall Study STARTED	30
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	PE-PC Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Overall Study Lost to Follow-up	10

Baseline Characteristics

Implementing PTSD Treatment in FQHCs for Michigan Medicaid Enrollees

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PE-PC n=30 Participants Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Age, Continuous	40.5 years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex/Gender, Customized Female	25 Participants n=5 Participants
Sex/Gender, Customized Male	4 Participants n=5 Participants
Sex/Gender, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized African-American	12 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4-months

Population: Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).

The PCL-5 is a 20-item self-report measure designed to assess PTSD symptoms as defined by the DSM-5. Each item of the PCL-5 is scored on a five point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80).The PCL-5 has strong internal consistency, test-retest reliability, and convergent and discriminant validity. Scores ≥ 33 indicate a probable diagnosis of PTSD. Data presented represent a change from baseline PCL-5 assessment to the 4-month PCL-5 assessment (e.g., value at baseline minus value at 4 months).

Outcome measures

Outcome measures
Measure	PE-PC n=30 Participants Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Change in PTSD Symptoms (as Measured by the PCL-5)	31.4 score on a scale Interval 18.5 to 44.3

SECONDARY outcome

Timeframe: Baseline, 4-months

Population: Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).

The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day) with a range of scores between 0-27. Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Data presented represent a change from baseline PHQ-9 assessment to the 4-month PHQ-9 assessment (e.g., value at baseline minus value at 4 months).

Outcome measures

Outcome measures
Measure	PE-PC n=30 Participants Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Change in Depressive Symptoms (as Measured by the PHQ-9)	8.5 score on a scale Interval 3.7 to 13.3

SECONDARY outcome

Timeframe: Baseline, 4-months

Population: Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).

Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. All items on the RAS assessment are rated on a 5-point Likert scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Not Sure, 4 = Agree, and 5 = Strongly Agree with a range of scores between 20-100. All items are summed to compute a total score. Higher scores indicate greater recovery orientation. The RAS-SF shows evidence for both convergent and discriminant validity when compared to quality of life, social support, and symptomatic scales. Data presented represent a change from baseline RAS-SF assessment to the 4-month RAS-SF assessment (e.g., value at baseline minus value at 4 months)).

Outcome measures

Outcome measures
Measure	PE-PC n=30 Participants Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Change in Recovery Goals (Measured by the Recovery Assessment Scale; RAS)	9.57 score on a scale Standard Deviation 16.34

SECONDARY outcome

Timeframe: Baseline, 4-months

Population: Thirty patients were included in the final analysis. The analysis strategy was intent-to-treat, and multiple imputation was used to impute missing follow-up data. We included auxiliary variables that were correlated with the missing variables at r \> 0.4 (Enders, 2010).

The PTCI is a 33-item scale of trauma-related thoughts and beliefs which is rated on a Likert-type scale ranging from 1 (totally disagree) to 7 (totally agree). It is composed of 3 subscales. Each subscale is calculated by averaging the items in the subscale. The PTCI total score is calculated as the sum of the three subscales and ranges from 3 to 21. Results reported here are total scores, not subscale scores. Higher scores represent more dysfunctional cognitions. Data presented represent a change from baseline PTCI assessment to the 4-month PTCI assessment (e.g., value at baseline minus value at 4 months).

Outcome measures

Outcome measures
Measure	PE-PC n=30 Participants Eligible participants who present to participating CHCs and screen positive for PTSD will be offered PE-PC via telepsychiatry. PE-PC: PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
Change in Posttraumatic Cognitions (Measured by the Post-Traumatic Cognitions Inventory; PTCI)	2.65 score on a scale Standard Deviation 4.04

Adverse Events

PE-PC

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

Rebecca Sripada

Michigan Medicine

Phone: 734-222-7432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place