Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT)

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02645929
Collaborator
(none)
29
1
49
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Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Interpersonal Psychotherapy (IPT)

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

Study Type:
Observational
Actual Enrollment :
29 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Reflective Function as a Mediator of Interpersonal Psychotherapy (IPT) for Posttraumatic Stress Disorder
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Outcome Measures

Primary Outcome Measures

  1. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) [14 weeks]

    The CAPS-5 is the standard measure for PTSD symptom severity

Secondary Outcome Measures

  1. Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS) [Administered at study weeks 0, 4, and 14]

    This measure of separation anxiety is a proxy for attachment dysregulation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria: Method of Ascertainment:
  1. Age 18 and older History

  2. Primary diagnosis of DSM-5 PTSD Clinical interview: CAPS-5

  3. Significant distress affecting social/ occupational functioning Clinical interview, self-report measures PHQ-9, GAD-7, PCL-5, DRRI-2

  4. Prior military service (for veteran) or significant relationship with individual with prior military service (for family member) History

  5. Able to give consent, fluent in English or Spanish Clinical assessment

Exclusion Criteria:
  1. History of Axis I psychiatric diagnosis of psychotic disorder, bipolar disorder, antisocial personality disorder Clinical assessment

  2. Unstable or life threatening medical condition Clinical assessment

  3. Acute suicide or homicide risk Clinical assessment

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York State Psychiatric Institute New York New York United States 10032

Sponsors and Collaborators

  • New York State Psychiatric Institute

Investigators

  • Principal Investigator: John C Markowitz, M.D., New York State Psychiatric Institute/Columbia University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
John Markowitz, Research Psychiatrist 2; Professor of Clinical Psychiatry, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT02645929
Other Study ID Numbers:
  • 7211
First Posted:
Jan 5, 2016
Last Update Posted:
Jul 1, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 1, 2020