NCT02645929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

4.1 years

First QC Date

January 3, 2016

Last Update Submit

June 29, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

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

    14 weeks

Secondary Outcomes (1)

  • Structured Clinical Interview for Separation Anxiety Symptoms (SCI-SAS)

    Administered at study weeks 0, 4, and 14

Interventions

IPT is a 14 week psychotherapy for PTSD. SSRF is a brief interview to assess emotional understanding of one's symptoms.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 US veterans or their family members suffering from DSM-5 PTSD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (6)

  • 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.

    PMID: 25677355BACKGROUND
  • 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.

    PMID: 20068250BACKGROUND
  • 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.

    PMID: 26653052BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • John C Markowitz, M.D.

    New York State Psychiatric Institute/Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychiatrist 2; Professor of Clinical Psychiatry

Study Record Dates

First Submitted

January 3, 2016

First Posted

January 5, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

No. We will be happy to release anonymized group data, beginning with its publication.

Locations