Trial Outcomes & Findings for Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families (NCT NCT03256227)

NCT ID: NCT03256227

Last Updated: 2024-06-14

Results Overview

Number of treatment sessions attended by the participant

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 128 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2024-06-14

Participant Flow

Participant milestones

Measure	Family Supported Prolonged Exposure The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy. Family Supported Prolonged Exposure: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.	Standard Prolonged Exposure Standard Prolonged Exposure for PTSD as delivered in routine VA care. Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Overall Study STARTED	64	64
Overall Study COMPLETED	36	25
Overall Study NOT COMPLETED	28	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

Baseline characteristics by cohort

Measure	Family Supported Prolonged Exposure n=64 Participants The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy. Family Supported Prolonged Exposure: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.	Standard Prolonged Exposure n=64 Participants Standard Prolonged Exposure for PTSD as delivered in routine VA care. Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care.	Total n=128 Participants Total of all reporting groups
Age, Continuous	49.30 years STANDARD_DEVIATION 14.70 • n=5 Participants	51.23 years STANDARD_DEVIATION 15.04 • n=7 Participants	50.38 years STANDARD_DEVIATION 14.81 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic/Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	41 Participants n=5 Participants	36 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Multiracial	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Unknown	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Lives with Significant Other	48 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Number of treatment sessions attended by the participant

Outcome measures

Measure	Family Supported Prolonged Exposure n=64 Participants The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy. Family Supported Prolonged Exposure: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.	Standard Prolonged Exposure n=64 Participants Standard Prolonged Exposure for PTSD as delivered in routine VA care. Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Session Attendance	6.77 sessions Standard Deviation 3.99	5.56 sessions Standard Deviation 4.16

SECONDARY outcome

Timeframe: 16 weeks

Population: Veterans who completed PCL5 measure at post treatment

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels.

Outcome measures

Measure	Family Supported Prolonged Exposure n=62 Participants The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy. Family Supported Prolonged Exposure: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.	Standard Prolonged Exposure n=62 Participants Standard Prolonged Exposure for PTSD as delivered in routine VA care. Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
PTSD Checklist for DSM-5 (PCL-5)	51.56 score on a scale Standard Deviation 12.60	53.79 score on a scale Standard Deviation 12.54

Adverse Events

Family Supported Prolonged Exposure

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Standard Prolonged Exposure

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Family Supported Prolonged Exposure n=64 participants at risk The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy. Family Supported Prolonged Exposure: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.	Standard Prolonged Exposure n=64 participants at risk Standard Prolonged Exposure for PTSD as delivered in routine VA care. Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Psychiatric disorders Severe Suicidal ideation	3.1% 2/64 • Number of events 2 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.	1.6% 1/64 • Number of events 1 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.
Psychiatric disorders Psychological decompisation	0.00% 0/64 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.	1.6% 1/64 • Number of events 1 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.

Other adverse events

Measure	Family Supported Prolonged Exposure n=64 participants at risk The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy. Family Supported Prolonged Exposure: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.	Standard Prolonged Exposure n=64 participants at risk Standard Prolonged Exposure for PTSD as delivered in routine VA care. Standard Prolonged Exposure: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
General disorders ER visit	17.2% 11/64 • Number of events 24 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.	21.9% 14/64 • Number of events 18 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.
General disorders Hospitalization	12.5% 8/64 • Number of events 14 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.	9.4% 6/64 • Number of events 9 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.
Psychiatric disorders Mild Suicidal ideation	0.00% 0/64 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.	3.1% 2/64 • Number of events 2 • Treatment initiation through 3 month follow-up, up to 40 weeks. This is a minimal risk study, so likelihood of mortality is zero.

Additional Information

Laura Meis, PhD

Minneapolis VA Health Care System

Phone: 612-467-4516

Email: laura.meis@va.gov

Results disclosure agreements

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