An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02956434|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2016
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Neuroses||Behavioral: Brief Family Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||An Adjunctive Family Intervention for Individual PTSD Treatment|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Brief family intervention
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.
Behavioral: Brief Family Intervention
Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
No Intervention: No intervention
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 [ Time Frame: 16 weeks ]A measure of PTSD severity and diagnostic status
- Treatment attendance/dropout [ Time Frame: 16 weeks ]A measure of Veterans' treatment attendance or premature dropout
- Significant Others' Responses to Trauma Scale (SORTS) [ Time Frame: 16 weeks ]A measure of self-reported family accommodation of PTSD symptoms
- Revised Dyadic Adjustment Scale [ Time Frame: 16 weeks ]A measure of relationship quality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956434
|United States, Massachusetts|
|VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Johanna Thompson-Hollands, PhD||VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA|