Back to resultsAn Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment
Primary Purpose
Posttraumatic Neuroses
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Family Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Neuroses
Eligibility Criteria
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
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Brief family intervention
No intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Revised Dyadic Adjustment Scale
A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.
Full Information
NCT ID
NCT02956434
First Posted
November 2, 2016
Last Updated
November 12, 2021
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02956434
Brief Title
An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment
Official Title
An Adjunctive Family Intervention for Individual PTSD Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
May 5, 2020 (Actual)
Study Completion Date
May 5, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Neuroses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief family intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Family Intervention
Intervention Description
Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale, 5th Edition
Description
A measure of PTSD severity and diagnostic status. Min value = 0, max value = 80. Higher scores mean worse outcome.
Time Frame
16 weeks
Title
Treatment Attendance/Dropout
Description
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
Secondary Outcome Measure Information:
Title
Significant Others' Responses to Trauma Scale (SORTS)
Description
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
Title
Revised Dyadic Adjustment Scale
Description
A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanna Thompson-Hollands, PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data may be released to other researchers as VA policy allows.
IPD Sharing Time Frame
Entire study (baseline to 16 weeks)
IPD Sharing Access Criteria
As per VA policy and local IRB approval
Learn more about this trial
An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment
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