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Behavioral Intervention
Trauma-focused Psychotherapy for PTSD and HIV (TFPP-PLWH Trial)
N/A
Recruiting
Led By Barbara Milrod, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 5, week 12 (treatment termination), 3-month post-treatment follow-up
Awards & highlights
TFPP-PLWH Trial Summary
This trial is testing a new psychotherapy to help people living with HIV manage their PTSD, and understand the relationship between HIV and PTSD.
Who is the study for?
This trial is for people living with HIV who also have PTSD. Participants must have a confirmed diagnosis of PTSD with a certain severity score and be on stable psychiatric medication for at least two months, which will continue during the study.Check my eligibility
What is being tested?
The trial is testing trauma-focused psychodynamic psychotherapy, a type of therapy that helps patients reflect on emotions and relationships affected by trauma without directly exposing them to traumatic memories.See study design
What are the potential side effects?
Since this is a psychological therapy, side effects may include emotional discomfort or distress as individuals explore difficult experiences and feelings related to their trauma.
TFPP-PLWH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 5, week 12 (treatment termination), 3-month post-treatment follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 5, week 12 (treatment termination), 3-month post-treatment follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Secondary outcome measures
Attrition from treatment by end of therapy duration
Change in AIDS Clinical Trials Group Adherence Questionnaire
Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)
+9 moreTFPP-PLWH Trial Design
1Treatment groups
Experimental Treatment
Group I: Trauma-focused psychodynamic psychotherapyExperimental Treatment1 Intervention
Twice-weekly psychotherapy for 24 sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trauma-focused psychodynamic psychotherapy
2020
N/A
~20
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
443 Previous Clinical Trials
582,516 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,270 Previous Clinical Trials
5,485,217 Total Patients Enrolled
Barbara Milrod, MDPrincipal InvestigatorMontefiore Medical Center
2 Previous Clinical Trials
276 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.My mental health medication has been stable for 2 months and will continue.I have been diagnosed with PTSD and my severity score is 25 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Trauma-focused psychodynamic psychotherapy
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.
Is this medical experiment open to individuals who are twenty-five years or older?
"This medical research is open to any adult between 18 and 65 years old."
Answered by AI
Is it possible for me to join the research team of this clinical trial?
"This trial is seeking 20 volunteers with post-traumatic stress disorder, aged between 18 and 65."
Answered by AI
Are there any current openings for participants in this experiment?
"Based on what is presented in clinicaltrials.gov, this trial does not appear to be actively searching for participants at present. The first posting was made on August 1st 2023 and the last edit date recorded was June 30th 2023. Despite this, there are 625 other trials that are seeking enrolment as of now."
Answered by AI
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