PTSDNCT02645929
Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT)
An observational study of PTSD, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Our recent randomized controlled trial of psychotherapies for posttraumatic stress disorder (PTSD) showed that Interpersonal Psychotherapy (IPT) benefitted patients. The mechanism of action for IPT is unclear; unlike most PTSD therapies, it does not work through exposure to trauma reminders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD
- What is being tested?
- Interpersonal Psychotherapy (IPT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25 US veterans or their family members suffering from DSM-5 PTSD
Who may be able to join
- Age 18 and older History
- Primary diagnosis of DSM-5 PTSD Clinical interview: CAPS-5
- Significant distress affecting social/ occupational functioning Clinical interview, self-report measures PHQ-9, GAD-7, PCL-5, DRRI-2
- Prior military service (for veteran) or significant relationship with individual with prior military service (for family member) History
- Able to give consent, fluent in English or Spanish Clinical assessment
Who cannot join
- History of Axis I psychiatric diagnosis of psychotic disorder, bipolar disorder, antisocial personality disorder Clinical assessment
- Unstable or life threatening medical condition Clinical assessment
- Acute suicide or homicide risk Clinical assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT) for Posttraumatic Stress Disorder
Our recent randomized controlled trial of psychotherapies for posttraumatic stress disorder (PTSD) showed that Interpersonal Psychotherapy (IPT) benefitted patients. The mechanism of action for IPT is unclear; unlike most PTSD therapies, it does not work through exposure to trauma reminders. This assessment study will assess Symptom-Specific Reflective Function, a measure of emotional awareness of one's PTSD symptoms, as a potential mediator of IPT, capitalizing on naturalistic treatment of military veterans with PTSD at Columbia University/New York State Psychiatric Institute.
Read the detailed description
In a randomized controlled study, the investigators recently showed that fourteen weeks of treatment with Interpersonal Psychotherapy (IPT) worked at least as well as the best studied exposure therapy in relieving symptoms of posttraumatic stress disorder (PTSD) (American Journal of Psychiatry, 2015). The investigators do not know the mechanism by which IPT works, however, except that it does not work through exposing patients to reminders of their trauma, as most exposure therapies for PTSD do. Rather, IPT seems to work in part by helping numbed patients to reconnect with and to understand their feelings, then use those feelings to handle interpersonal encounters with other people. One promising measure of this possible mechanism of IPT is Reflective Function, which has two components.
Reflective Functioning (RF) measures how well an individual understands his or her emotions as well as the emotions of significant other people in his or her life. A separate aspect is Symptom-Specific Reflective Function (SSRF), which gauges the individual's emotional understanding of his or her PTSD symptoms. Both RF and SSRF can be measured in a tape recorded interview that takes about 20 minutes, in which the interviewer asks the patient to describe relationships with important people in the patient's life, as well as questions about the patient's understanding of his or her symptoms. The tape is then transcribed for scoring.
A Veterans Clinic at New York State Psychiatric Institute to treat armed service veterans and their families who have PTSD and other psychiatric disorders has opened. This clinic is covered under a separate IRB protocol. As some of the patients in that clinic will receive treatment with IPT, the investigators propose to assess RF, SSRF, and a related measure, the Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS), at three points in treatment (before treatment starts; at week 4; and after treatment ends, at week 14) to see whether change in SSRF in particular accounts for improvement in PTSD as measured by the Clinician-Administered PTSD Scale (CAPS), which will be assessed pre-treatment (week 0), mid-treatment (week 7), and post-treatment (week 14). Both veterans and their family members will be eligible for this protocol so long as they meet study eligibility criteria. Because there is no reason to expect that psychotropic medication alters RF, patients who are taking stable doses of medication will be allowed to continue them during IPT treatment.
- Conditions
- PTSD
- Being tested
- Interpersonal Psychotherapy (IPT)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Psychotherapy (IPT)Behavioural
IPT is a 14 week psychotherapy for PTSD. SSRF is a brief interview to assess emotional understanding of one's symptoms.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is the standard measure for PTSD symptom severity
Measured: 14 weeks
Secondary outcomes (1)
Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS)
This measure of separation anxiety is a proxy for attachment dysregulation.
Measured: Administered at study weeks 0, 4, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Markowitz, New York State Psychiatric Institute
- Investigators
- John C Markowitz, M.D., Principal investigator, New York State Psychiatric Institute/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645929
- Sponsor's protocol ID
- 7211
- Status last verified
- Jun 2020
- First submitted
- 3 Jan 2016
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. We will be happy to release anonymized group data, beginning with its publication.
Publications
Markowitz JC, Petkova E, Neria Y, Van Meter PE, Zhao Y, Hembree E, Lovell K, Biyanova T, Marshall RD. Is Exposure Necessary? A Randomized Clinical Trial of Interpersonal Psychotherapy for PTSD. Am J Psychiatry. 2015 May;172(5):430-40. doi: 10.1176/appi.ajp.2014.14070908. Epub 2015 Feb 13.
PubMed 25677355Rudden MG, Milrod B, Meehan KB, Falkenstrom F. Symptom-specific reflective functioning: incorporating psychoanalytic measures into clinical trials. J Am Psychoanal Assoc. 2009 Dec;57(6):1473-8. doi: 10.1177/00030651090570060804. No abstract available.
PubMed 20068250Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
PubMed 26653052Markowitz JC, Milrod B, Luyten P, Holmqvist R. Mentalizing in Interpersonal Psychotherapy. Am J Psychother. 2019 Dec 1;72(4):95-100. doi: 10.1176/appi.psychotherapy.20190021. Epub 2019 Nov 22.
PubMed 31752509Markowitz JC, Lowell A, Milrod BL, Lopez-Yianilos A, Neria Y. Symptom-Specific Reflective Function as a Potential Mechanism of Interpersonal Psychotherapy Outcome: A Case Report. Am J Psychother. 2020 Mar 1;73(1):35-40. doi: 10.1176/appi.psychotherapy.20190026. Epub 2020 Jan 6. No abstract available.
PubMed 31902227Milrod B, Keefe JR, Choo TH, Arnon S, Such S, Lowell A, Neria Y, Markowitz JC. Separation anxiety in PTSD: A pilot study of mechanisms in patients undergoing IPT. Depress Anxiety. 2020 Apr;37(4):386-395. doi: 10.1002/da.23003. Epub 2020 Feb 25.
PubMed 32097526
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT) for Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02645929
- Acronym / sponsor ID
- 7211
- Conditions
- PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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.
Our recent randomized controlled trial of psychotherapies for posttraumatic stress disorder (PTSD) showed that Interpersonal Psychotherapy (IPT) benefitted patients. The mechanism of action for IPT is unclear; unlike most PTSD therapies, it does not work through exposure to trauma reminders. This assessment study will assess Symptom-Specific Reflective Function, a measure of emotional awareness of one's PTSD symptoms, as a potential mediator of IPT, capitalizing on naturalistic treatment of military veterans with PTSD at Columbia University/New York State Psychiatric Institute.
Detailed description
In a randomized controlled study, the investigators recently showed that fourteen weeks of treatment with Interpersonal Psychotherapy (IPT) worked at least as well as the best studied exposure therapy in relieving symptoms of posttraumatic stress disorder (PTSD) (American Journal of Psychiatry, 2015). The investigators do not know the mechanism by which IPT works, however, except that it does not work through exposing patients to reminders of their trauma, as most exposure therapies for PTSD do. Rather, IPT seems to work in part by helping numbed patients to reconnect with and to understand their feelings, then use those feelings to handle interpersonal encounters with other people. One promising measure of this possible mechanism of IPT is Reflective Function, which has two components.
Reflective Functioning (RF) measures how well an individual understands his or her emotions as well as the emotions of significant other people in his or her life. A separate aspect is Symptom-Specific Reflective Function (SSRF), which gauges the individual's emotional understanding of his or her PTSD symptoms. Both RF and SSRF can be measured in a tape recorded interview that takes about 20 minutes, in which the interviewer asks the patient to describe relationships with important people in the patient's life, as well as questions about the patient's understanding of his or her symptoms. The tape is then transcribed for scoring.
A Veterans Clinic at New York State Psychiatric Institute to treat armed service veterans and their families who have PTSD and other psychiatric disorders has opened. This clinic is covered under a separate IRB protocol. As some of the patients in that clinic will receive treatment with IPT, the investigators propose to assess RF, SSRF, and a related measure, the Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS), at three points in treatment (before treatment starts; at week 4; and after treatment ends, at week 14) to see whether change in SSRF in particular accounts for improvement in PTSD as measured by the Clinician-Administered PTSD Scale (CAPS), which will be assessed pre-treatment (week 0), mid-treatment (week 7), and post-treatment (week 14). Both veterans and their family members will be eligible for this protocol so long as they meet study eligibility criteria. Because there is no reason to expect that psychotropic medication alters RF, patients who are taking stable doses of medication will be allowed to continue them during IPT treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 US veterans or their family members suffering from DSM-5 PTSD
Key inclusion criteria (5 listed)
- Age 18 and older History
- Primary diagnosis of DSM-5 PTSD Clinical interview: CAPS-5
- Significant distress affecting social/ occupational functioning Clinical interview, self-report measures PHQ-9, GAD-7, PCL-5, DRRI-2
- Prior military service (for veteran) or significant relationship with individual with prior military service (for family member) History
- Able to give consent, fluent in English or Spanish Clinical assessment
Key exclusion criteria (3 listed)
- History of Axis I psychiatric diagnosis of psychotic disorder, bipolar disorder, antisocial personality disorder Clinical assessment
- Unstable or life threatening medical condition Clinical assessment
- Acute suicide or homicide risk Clinical assessment
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 |
|---|---|---|
| Interpersonal Psychotherapy (IPT)IPT is a 14 week psychotherapy for PTSD. SSRF is a brief interview to assess emotional understanding of one's symptoms. | Behavioural | – |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: 14 weeks
The CAPS-5 is the standard measure for PTSD symptom severity
1 secondary outcome
Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS)
Time frame: Administered at study weeks 0, 4, and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 25677355Markowitz JC, Petkova E, Neria Y, Van Meter PE, Zhao Y, Hembree E, Lovell K, Biyanova T, Marshall RD. Is Exposure Necessary? A Randomized Clinical Trial of Interpersonal Psychotherapy for PTSD. Am J Psychiatry. 2015 May;172(5):430-40. doi: 10.1176/appi.ajp.2014.14070908. Epub 2015 Feb 13.
- Background: PubMed 20068250Rudden MG, Milrod B, Meehan KB, Falkenstrom F. Symptom-specific reflective functioning: incorporating psychoanalytic measures into clinical trials. J Am Psychoanal Assoc. 2009 Dec;57(6):1473-8. doi: 10.1177/00030651090570060804. No abstract available.
- Background: PubMed 26653052Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
- Results publication: PubMed 31752509Markowitz JC, Milrod B, Luyten P, Holmqvist R. Mentalizing in Interpersonal Psychotherapy. Am J Psychother. 2019 Dec 1;72(4):95-100. doi: 10.1176/appi.psychotherapy.20190021. Epub 2019 Nov 22.
- Results publication: PubMed 31902227Markowitz JC, Lowell A, Milrod BL, Lopez-Yianilos A, Neria Y. Symptom-Specific Reflective Function as a Potential Mechanism of Interpersonal Psychotherapy Outcome: A Case Report. Am J Psychother. 2020 Mar 1;73(1):35-40. doi: 10.1176/appi.psychotherapy.20190026. Epub 2020 Jan 6. No abstract available.
- Results publication: PubMed 32097526Milrod B, Keefe JR, Choo TH, Arnon S, Such S, Lowell A, Neria Y, Markowitz JC. Separation anxiety in PTSD: A pilot study of mechanisms in patients undergoing IPT. Depress Anxiety. 2020 Apr;37(4):386-395. doi: 10.1002/da.23003. Epub 2020 Feb 25.
- Columbia PTSD and trauma websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No. We will be happy to release anonymized group data, beginning with its publication.
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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. This study is not recruiting at the moment.
John C Markowitz, M.D. principal investigator
New York State Psychiatric Institute/Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by New York State Psychiatric Institute 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 7 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: 14 weeks). 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 NCT02645929, which also lists 6 linked publications.
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 7 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.