Posttraumatic Neuroses
Conditions
Brief summary
This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.
Detailed description
The investigators will enroll pairs of Veterans and one adult family member who lives with them. Veterans will be beginning a course of PTSD-focused treatment at the Boston VA; Veterans' treatment will not be limited or changed by their participation in this study. Family members will receive or not receive (depending on which Phase of the study they are recruited in) the BFI. The BFI consists of 2 sessions in which the family member meets one-on-one with a clinician to discuss PTSD, PTSD treatment, and how families can be most helpful to patients in treatment. Veterans and family members will also be interviewed about their opinions and experiences regarding family-inclusive treatment for PTSD. Clinicians will be recruited and enrolled to obtain their information and feedback (via qualitative interviews), and to deliver the intervention in Phase II.
Interventions
BEHAVIORALBrief Family Intervention
Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans must have a diagnosis of PTSD and be beginning a course of Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT) at the Boston VA. * Must also have an eligible family member who is willing to participate.
Exclusion criteria
* Current diagnosis of unstable bipolar disorder, substance dependence, past or present psychosis, or organic mental disorder * Clear and current suicidal risk * Current participation in family/couples therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale, 5th Edition | 16 weeks | A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome. |
| Treatment Attendance/Dropout | 16 weeks | A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Significant Others' Responses to Trauma Scale (SORTS) | 16 weeks | A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome. |
| Revised Dyadic Adjustment Scale | 16 weeks | A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brief Family Intervention - Veterans 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. | 10 |
| Usual-care CPT/PE - Veterans 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. | 10 |
| Brief Family Intervention - Family Members 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. | 10 |
| No Intervention - Family Members 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. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Brief Family Intervention - Veterans | Usual-care CPT/PE - Veterans | Brief Family Intervention - Family Members | No Intervention - Family Members | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.40 years STANDARD_DEVIATION 18.12 | 38.70 years STANDARD_DEVIATION 10.02 | 45.70 years STANDARD_DEVIATION 17.25 | 38.30 years STANDARD_DEVIATION 11.44 | 43.02 years STANDARD_DEVIATION 14.852 |
| CAPS-5 | 37.80 units on a scale STANDARD_DEVIATION 8.81 | 42.40 units on a scale STANDARD_DEVIATION 8.81 | — | — | 40.10 units on a scale STANDARD_DEVIATION 9.341 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 8 Participants | 7 Participants | 9 Participants | 30 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 0 Participants | 0 Participants | 20 Participants |
| SORTS | — | — | 33.30 units on a scale STANDARD_DEVIATION 21.79 | 45.40 units on a scale STANDARD_DEVIATION 27.24 | 39.35 units on a scale STANDARD_DEVIATION 26.061 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 2 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Clinician-Administered PTSD Scale, 5th Edition
A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.
Time frame: 16 weeks
Population: Only Veterans
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Family Intervention | Clinician-Administered PTSD Scale, 5th Edition | 18.60 score on a scale | Standard Deviation 10.98 |
| No Intervention | Clinician-Administered PTSD Scale, 5th Edition | 21.21 score on a scale | Standard Deviation 9.91 |
Primary
Treatment Attendance/Dropout
A measure of Veterans' treatment attendance or premature dropout. Data represents the Veterans who dropped out of their standard-care PTSD treatment.
Time frame: 16 weeks
Population: Only veterans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brief Family Intervention | Treatment Attendance/Dropout | 2 Participants |
| No Intervention | Treatment Attendance/Dropout | 4 Participants |
Secondary
Revised Dyadic Adjustment Scale
A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.
Time frame: 16 weeks
Population: Only family members
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Family Intervention | Revised Dyadic Adjustment Scale | 50.60 score on a scale | Standard Deviation 8.38 |
| No Intervention | Revised Dyadic Adjustment Scale | 51.00 score on a scale | Standard Deviation 7.681 |
Secondary
Significant Others' Responses to Trauma Scale (SORTS)
A measure of self-reported family accommodation of PTSD symptoms. Min value = 0, max value = 112. Higher scores mean worse outcome.
Time frame: 16 weeks
Population: Only family members
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brief Family Intervention | Significant Others' Responses to Trauma Scale (SORTS) | 22.82 score on a scale | Standard Deviation 11.16 |
| No Intervention | Significant Others' Responses to Trauma Scale (SORTS) | 29.88 score on a scale | Standard Deviation 24.87 |