- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645929
Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT)
Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT) for Posttraumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Method of Ascertainment:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: 14 weeks
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The CAPS-5 is the standard measure for PTSD symptom severity
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14 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS)
Time Frame: Administered at study weeks 0, 4, and 14
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This measure of separation anxiety is a proxy for attachment dysregulation.
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Administered at study weeks 0, 4, and 14
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Collaborators and Investigators
Investigators
- Principal Investigator: John C Markowitz, M.D., New York State Psychiatric Institute/Columbia University
Publications and helpful links
General Publications
- Bovin 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.
- 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.
- Rudden 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.
- Markowitz 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.
- Markowitz 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.
- Milrod 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7211 (CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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