Trial Outcomes & Findings for An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment (NCT NCT02956434)
NCT ID: NCT02956434
Last Updated: 2021-12-08
Results Overview
A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
16 weeks
Results posted on
2021-12-08
Participant Flow
Participant milestones
| Measure |
Brief Family Intervention - Veterans
The family members of these veterans will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention - Veterans
The family members of these veterans will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
Brief Family Intervention - Family Members
Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention - Family Members
These family members will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only Veterans were administered the CAPS-5
Baseline characteristics by cohort
| Measure |
Brief Family Intervention - Veterans
n=10 Participants
Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.
Their chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE.
|
Usual-care CPT/PE - Veterans
n=10 Participants
Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.
Their chosen family member will NOT receive the BFI.
|
Brief Family Intervention - Family Members
n=10 Participants
Family members will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention - Family Members
n=10 Participants
Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.40 years
STANDARD_DEVIATION 18.12 • n=10 Participants
|
38.70 years
STANDARD_DEVIATION 10.02 • n=10 Participants
|
45.70 years
STANDARD_DEVIATION 17.25 • n=10 Participants
|
38.30 years
STANDARD_DEVIATION 11.44 • n=10 Participants
|
43.02 years
STANDARD_DEVIATION 14.852 • n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
20 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
9 Participants
n=10 Participants
|
30 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=40 Participants
|
|
CAPS-5
|
37.80 units on a scale
STANDARD_DEVIATION 8.81 • n=10 Participants • Only Veterans were administered the CAPS-5
|
42.40 units on a scale
STANDARD_DEVIATION 8.81 • n=10 Participants • Only Veterans were administered the CAPS-5
|
—
|
—
|
40.10 units on a scale
STANDARD_DEVIATION 9.341 • n=20 Participants • Only Veterans were administered the CAPS-5
|
|
SORTS
|
—
|
—
|
33.30 units on a scale
STANDARD_DEVIATION 21.79 • n=10 Participants • Only family members completed the SORTS
|
45.40 units on a scale
STANDARD_DEVIATION 27.24 • n=10 Participants • Only family members completed the SORTS
|
39.35 units on a scale
STANDARD_DEVIATION 26.061 • n=20 Participants • Only family members completed the SORTS
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Only Veterans
A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.
Outcome measures
| Measure |
Brief Family Intervention
n=10 Participants
Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention
n=10 Participants
Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
|---|---|---|
|
Clinician-Administered PTSD Scale, 5th Edition
|
18.60 score on a scale
Standard Deviation 10.98
|
21.21 score on a scale
Standard Deviation 9.91
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Only veterans
A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment.
Outcome measures
| Measure |
Brief Family Intervention
n=10 Participants
Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention
n=10 Participants
Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
|---|---|---|
|
Treatment Attendance/Dropout
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Only family members
A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome.
Outcome measures
| Measure |
Brief Family Intervention
n=10 Participants
Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention
n=10 Participants
Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
|---|---|---|
|
Significant Others' Responses to Trauma Scale (SORTS)
|
22.82 score on a scale
Standard Deviation 11.16
|
29.88 score on a scale
Standard Deviation 24.87
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Only family members
A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.
Outcome measures
| Measure |
Brief Family Intervention
n=10 Participants
Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention
n=10 Participants
Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
|---|---|---|
|
Revised Dyadic Adjustment Scale
|
50.60 score on a scale
Standard Deviation 8.38
|
51.00 score on a scale
Standard Deviation 7.681
|
Adverse Events
Brief Family Intervention - Veterans
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual-care CPT/PE - Veterans
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Family Intervention - Family Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Intervention - Family Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brief Family Intervention - Veterans
n=10 participants at risk
Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.
Their chosen family member will receive the BFI as an adjunctive treatment to the veteran's CPT/PE.
|
Usual-care CPT/PE - Veterans
n=10 participants at risk
Veterans will receive individually-delivered Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE) to treat their PTSD.
Their chosen family member will NOT receive the BFI.
|
Brief Family Intervention - Family Members
n=10 participants at risk
Participants will receive the BFI in this arm of the study. The BFI is a 2-session intervention for family members of Veterans who are beginning PTSD treatment.
Brief Family Intervention: Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
|
No Intervention - Family Members
n=10 participants at risk
Participants will not receive the BFI in this arm of the study. They will be eligible for any usual support or programming for the families of Veterans.
|
|---|---|---|---|---|
|
Psychiatric disorders
Medication overdose
|
0.00%
0/10 • 16 weeks
No difference in definitions
|
10.0%
1/10 • Number of events 1 • 16 weeks
No difference in definitions
|
0.00%
0/10 • 16 weeks
No difference in definitions
|
0.00%
0/10 • 16 weeks
No difference in definitions
|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/10 • 16 weeks
No difference in definitions
|
10.0%
1/10 • Number of events 1 • 16 weeks
No difference in definitions
|
0.00%
0/10 • 16 weeks
No difference in definitions
|
0.00%
0/10 • 16 weeks
No difference in definitions
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Johanna Thompson-Hollands
VA Boston Healthcare System
Phone: 857-364-2311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place