An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

Posttraumatic Neuroses Clinical Trial

Official title:

An Adjunctive Family Intervention for Individual PTSD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02956434
• Other study ID #: MHBB-013-16F
• Secondary ID: IK2CX001589
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: May 5, 2020

Study information

• Verified date: November 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test a brief family intervention (the BFI) to enhance individually-delivered PTSD treatment for Veterans.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Neuroses
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Brief Family Intervention
Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	16 weeks
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.	16 weeks
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.	16 weeks
Secondary	Revised Dyadic Adjustment Scale	A measure of relationship quality. Min value = 0, max value = 69. Higher scores mean better outcome.	16 weeks