Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 122 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Massachusetts, United States ) | NIH, U.S. Fed

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02956434
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

Condition or disease Intervention/treatment Phase
Posttraumatic Neuroses Behavioral: Brief Family Intervention Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale, 5th edition [ Time Frame: 16 weeks ]
    A measure of PTSD severity and diagnostic status

  2. Treatment attendance/dropout [ Time Frame: 16 weeks ]
    A measure of Veterans' treatment attendance or premature dropout


Secondary Outcome Measures :
  1. Significant Others' Responses to Trauma Scale (SORTS) [ Time Frame: 16 weeks ]
    A measure of self-reported family accommodation of PTSD symptoms

  2. Revised Dyadic Adjustment Scale [ Time Frame: 16 weeks ]
    A measure of relationship quality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Johanna Thompson-Hollands, PhD (857) 364-2067 Johanna.Thompson-Hollands@va.gov
Contact: Denise M Sloan, PhD (857) 364-6333 Denise.Sloan@va.gov

Locations
Layout table for location information
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Recruiting
Boston, Massachusetts, United States, 02130
Contact: Johanna Thompson-Hollands, PhD    857-364-2067    Johanna.Thompson-Hollands@va.gov   
Principal Investigator: Johanna Thompson-Hollands, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Johanna Thompson-Hollands, PhD VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02956434     History of Changes
Other Study ID Numbers: MHBB-013-16F
IK2CX001589 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be released to other researchers as VA policy allows.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Entire study (baseline to 16 weeks)
Access Criteria: As per VA policy and local IRB approval

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders