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Family Involvement for PTSD
N/A
Recruiting
Led By Johanna Thompson-Hollands, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- a current DSM-5 diagnosis of PTSD
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Study Summary
This trial is testing whether a brief family intervention (BFI) can help reduce the rate of treatment dropout and improve symptoms in veterans with PTSD who are receiving cognitive processing therapy (CPT) or prolonged exposure (PE).
Who is the study for?
This trial is for Veterans with PTSD who are starting or have just started individual CPT or PE therapy, and are willing to involve a family member. The Veteran must be stable on any psychotropic meds for at least 30 days. Family members over 18 who see the Veteran frequently but don't have PTSD can join.Check my eligibility
What is being tested?
The study tests if involving family in treatment through a Brief Family Intervention (BFI) helps Veterans with PTSD stick to their therapy better and improve symptoms more than usual care alone. It's a randomized test where some families get BFI while others don't.See study design
What are the potential side effects?
Since the intervention involves psychoeducation and skills training rather than medication, typical medical side effects aren't expected. However, discussing traumatic events could potentially cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adequate treatment dose
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Treatment dropout
Secondary outcome measures
Homework compliance
Quality of Life Inventory (QOLI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BFIExperimental Treatment1 Intervention
Family members in this arm receive the 2-session BFI intervention.
Group II: No BFIActive Control1 Intervention
Family members in this arm do not receive the BFI sessions
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,618 Previous Clinical Trials
3,315,973 Total Patients Enrolled
Johanna Thompson-Hollands, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PTSD.You have significant problems with your memory or thinking abilities.I have started CPT or PE therapy and have completed no more than 3 sessions.You have a serious problem with drug or alcohol addiction.You currently have a mental health condition called psychosis or unstable bipolar disorder.I have been on the same dose of my mental health medication for at least 30 days.I am currently in therapy with a family member.I am 18 or older and a family member of a Veteran.I am willing to involve a family member in the study.You have a high risk of wanting to harm yourself or commit suicide.
Research Study Groups:
This trial has the following groups:- Group 1: BFI
- Group 2: No BFI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count of this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this research endeavour which was first advertised on July 1st 2022 is actively recruiting 200 volunteers from two different study sites. The trial has been recently updated as of July 14th 2022."
Answered by AI
Is this research actively enrolling new participants?
"According to the latest update on clinicaltrials.gov, this study is actively recruiting participants as of July 14th 2022. It was initially posted on July 1st."
Answered by AI
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