Post Traumatic Stress Disorder (PTSD)TFPP-PLWHNCT05929911
Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD
A study testing Trauma-focused psychodynamic psychotherapy in people with Post Traumatic Stress Disorder (PTSD) and HIV, run by Montefiore Medical Center at 1 site in United States.
Trial summary
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder (PTSD), HIV
- What is being tested?
- Trauma-focused psychodynamic psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \& CAPS-5 total severity score greater than or equal to 25
- HIV diagnosis (by medical records or HIV testing)
- Stable psychiatric/psychotropic medication for >=2 months and ongoing during treatment
Who cannot join
- Psychosis
- Bipolar I
- Acute suicidality
- Current substance use disorder
- Organic mental syndrome or intellectual disability
- Unstable non-HIV medical conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
John R Keefe, PhD, 347-391-4189, john.keefe@einsteinmed.edu
Barbara L Milrod, MD, bmilrod@montefiore.org
About this study
Official title: Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
- Conditions
- Post Traumatic Stress Disorder (PTSD), HIV
- Being tested
- Trauma-focused psychodynamic psychotherapy
- Keywords
- HIV, psychotherapy, trauma
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-focused psychodynamic psychotherapyBehavioural
Also called TFPP
This psychotherapy addresses disruptions in the ability to reflect and affective regulation by exploring the psychological meanings of symptoms and their relation to traumatic events. The therapist works to identify intrapsychic conflicts, intense negative affects, and defense mechanisms related to the PTSD syndrome using a psychodynamic formulation that provides a framework for intervention. The transference provides a forum for patients to address feelings of mistrust, difficulties with authority, fears of abuse, angry and guilty feelings, and fantasies.
This treatment will be provided in-person or over teletherapy as the public health situation demands.
| Study group | Role | What they receive |
|---|---|---|
| Trauma-focused psychodynamic psychotherapy | Experimental | Twice-weekly psychotherapy for 24 sessions Receives: Behavioral: Trauma-focused psychodynamic psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Measured: Baseline
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Measured: Week 6
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Measured: Week 12 (treatment termination)
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Measured: 3-month post-treatment follow-up
Secondary outcomes (3)
Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS)
The HDRS (also known as the Ham-D) scale contains 17 items pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression, and scores over 24 are indicative of severe depression with the maximum score being 52 on the 17-point scale.
Measured: Baseline, Week 12 (treatment termination)
Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)
Severity of anxiety will be assessed using the Hamilton Rating Scale for Anxiety (HAM-A). The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe anxiety.
Measured: Baseline, Week 12 (treatment termination)
Change in Functional Impairment based on the Sheehan Disability Scale (SDS)
The Sheehan Disability Scale is a composite of three self-rated items designed to measure the extent to which three major domains in the patient's life are functionally impaired by psychiatric or medical symptoms. The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school (0-10 scoring range), social life (0-10 scoring range), and family life (0-10 scoring range). A composite range of 0-30 is possible. Scores of ≥5 on any of the 3 individual scales and overall higher totals scores are associated with significant functional impairment.
Measured: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start26 Apr 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), American Psychoanalytic Association (APsA)
- Responsible party
- Sponsor
- Investigators
- Barbara Milrod, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929911
- Sponsor's protocol ID
- 2023-15016
- Other IDs
- P30AI124414, 2023
- Acronym
- TFPP-PLWH
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kehn M, Milrod B, Chen CK. Clinical Case of Trauma-Focused Psychodynamic Psychotherapy for a Veteran With PTSD and Race-Based Trauma. Am J Psychother. 2024 Sep 1;77(3):146-150. doi: 10.1176/appi.psychotherapy.20230040. No abstract available.
PubMed 39277802
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD
- ClinicalTrials.gov ID
- NCT05929911
- Acronym / sponsor ID
- TFPP-PLWH / 2023-15016
- Conditions
- Post Traumatic Stress Disorder (PTSD), HIV
- Keywords
- HIV, psychotherapy, trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), American Psychoanalytic Association (APsA)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma-focused psychodynamic psychotherapy | Experimental | Behavioral: Trauma-focused psychodynamic psychotherapyTwice-weekly psychotherapy for 24 sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \& CAPS-5 total severity score greater than or equal to 25
- HIV diagnosis (by medical records or HIV testing)
- Stable psychiatric/psychotropic medication for >=2 months and ongoing during treatment
Key exclusion criteria (6 listed)
- Psychosis
- Bipolar I
- Acute suicidality
- Current substance use disorder
- Organic mental syndrome or intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-focused psychodynamic psychotherapyAlso: TFPPThis psychotherapy addresses disruptions in the ability to reflect and affective regulation by exploring the psychological meanings of symptoms and their relation to traumatic events. The therapist works to identify intrapsychic conflicts, intense negative affects, and defense mechanisms related to the PTSD syndrome using a psychodynamic formulation that provides a framework for intervention. The transference provides a forum for patients to address feelings of mistrust, difficulties with authority, fears of abuse, angry and guilty feelings, and fantasies. This treatment will be provided in-person or over teletherapy as the public health situation demands. | Behavioural | Trauma-focused psychodynamic psychotherapy |
Primary outcome
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: Baseline
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: Week 6
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: Week 12 (treatment termination)
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
Time frame: 3-month post-treatment follow-up
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
3 secondary outcomes
Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS)
Time frame: Baseline, Week 12 (treatment termination)
Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: Baseline, Week 12 (treatment termination)
Change in Functional Impairment based on the Sheehan Disability Scale (SDS)
Time frame: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 39277802Kehn M, Milrod B, Chen CK. Clinical Case of Trauma-Focused Psychodynamic Psychotherapy for a Veteran With PTSD and Race-Based Trauma. Am J Psychother. 2024 Sep 1;77(3):146-150. doi: 10.1176/appi.psychotherapy.20230040. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Milrod, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-focused psychodynamic psychotherapy in people with Post Traumatic Stress Disorder (PTSD) and HIV, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John R Keefe, PhD (703-981-7184, john.keefe@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05929911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.