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An Adjunctive Family Intervention for Individual Posttraumatic Stress Disorder Treatment

NCT ID: NCT02956434

Last Updated: 2021-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-05-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Posttraumatic Neuroses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Brief Family Intervention

Intervention Type BEHAVIORAL

Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief Family Intervention

Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johanna Thompson-Hollands, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IK2CX001589

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MHBB-013-16F

Identifier Type: -

Identifier Source: org_study_id