Trial Outcomes & Findings for Teaching Loved Ones to Help Veterans Optimize Their PTSD Care and Healing (NCT NCT04241094)
NCT ID: NCT04241094
Last Updated: 2024-07-01
Results Overview
Structured clinical interview assessing symptoms of PTSD. CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Severity scores range from 0 to 80 and higher scores correspond with more severe symptoms of PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Up to 26 weeks post baseline
Results posted on
2024-07-01
Participant Flow
28 Veterans were consented and signed informed consent for the study. Only 20 of those 28 went forward with the COACH treatment.
The numbers in this chart are counted as individual participants. 28 participants (16 Veterans and 12 loved ones) consented to the study. Of those 28, only 20 participants (10 Veterans and 10 loved ones) started treatment in the study.
Participant milestones
| Measure |
Loved One Assisted Treatment
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Never Started Treatment
|
8
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Loved One Assisted Treatment
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
|
|---|---|
|
Overall Study
Dropped out of treatment
|
4
|
|
Overall Study
Ineligible after clinical assessment
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
There are two cohort types in this study: Veterans and loved ones
Baseline characteristics by cohort
| Measure |
Loved One Assisted Treatment
n=20 Participants
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
|
|---|---|
|
Age, Categorical
Veterans · <=18 years
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Age, Categorical
Veterans · Between 18 and 65 years
|
10 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Age, Categorical
Veterans · >=65 years
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Age, Categorical
Loved Ones · <=18 years
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Age, Categorical
Loved Ones · Between 18 and 65 years
|
10 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Age, Categorical
Loved Ones · >=65 years
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Sex: Female, Male
Veterans · Female
|
4 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Sex: Female, Male
Veterans · Male
|
6 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Sex: Female, Male
Loved ones · Female
|
7 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Sex: Female, Male
Loved ones · Male
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Ethnicity (NIH/OMB)
Veterans · Hispanic or Latino
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Ethnicity (NIH/OMB)
Veterans · Not Hispanic or Latino
|
10 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Ethnicity (NIH/OMB)
Veterans · Unknown or Not Reported
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Ethnicity (NIH/OMB)
Loved ones · Hispanic or Latino
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Ethnicity (NIH/OMB)
Loved ones · Not Hispanic or Latino
|
10 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Ethnicity (NIH/OMB)
Loved ones · Unknown or Not Reported
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · American Indian or Alaska Native
|
1 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · Asian
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · Black or African American
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · White
|
8 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · More than one race
|
1 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Veterans · Unknown or Not Reported
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · American Indian or Alaska Native
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · Asian
|
1 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · Black or African American
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · White
|
8 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · More than one race
|
1 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Race (NIH/OMB)
Loved ones · Unknown or Not Reported
|
0 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Veterans · 6+ months
|
1 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Veterans · 1-4 years
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Veterans · 5-10 years
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Veterans · 11+ years
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Loved ones · 6+ months
|
1 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Loved ones · 1-4 years
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Loved ones · 5-10 years
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
|
Length of relationship
Loved ones · 11+ years
|
3 Participants
n=10 Participants • There are two cohort types in this study: Veterans and loved ones
|
PRIMARY outcome
Timeframe: Up to 26 weeks post baselinePopulation: Veteran participants
Structured clinical interview assessing symptoms of PTSD. CAPS-5 is a 30-item questionnaire, corresponding to the DSM-5 diagnosis for PTSD. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. Severity scores range from 0 to 80 and higher scores correspond with more severe symptoms of PTSD.
Outcome measures
| Measure |
Loved One Assisted Treatment at Baseline
n=10 Participants
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2. This is data from Veterans before treatment begins.
|
Loved One Assisted Treatment at Posttreatment
n=6 Participants
The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
Loved one assisted treatment: The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2. This is data from Veterans after treatment ended.
|
|---|---|---|
|
Clinician Administered PTSD Scale for DSM-5 to Assess Changes in PTSD Symptoms.
|
35.3 score on scale
Standard Deviation 9.12
|
11.33 score on scale
Standard Deviation 7.26
|
Adverse Events
Loved One Assisted Treatment
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
Laura Meis, PhD
Center for Care Delivery & Outcomes Research
Phone: 651-467-4516
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place