Implementation of Brief Dynamic Interpersonal Therapy at the VA (DIT)

March 30, 2021 updated by: Cory K. Chen, PhD, VA New York Harbor Healthcare System
The goal of the proposed project is to collect data from clinician files and the electronic medical record to describe the clinical implementation of Brief Dynamic Interpersonal Therapy (DIT), an individual psychotherapy for depression and anxiety, at the VA through psychology staff and trainees between 2012-present.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of the proposed project is to collect data from clinician files and the electronic medical record to describe the clinical implementation of Brief Dynamic Interpersonal Therapy (DIT), an individual psychotherapy for depression and anxiety, at the VA through psychology staff and trainees between 2012-present. The study will collect data on patient characteristics (e.g. demographics, diagnoses, reasons for referral, etc.), attendance, and treatment outcome of depression, anxiety and psychosocial functioning to evaluate and describe the feasibility of implementing DIT at the VA.

Medical records of veterans who were provided with DIT treatment between 2012-present will be reviewed and data on patient characteristics (which will include demographic information, diagnoses, reasons for referral, etc.), treatment compliance, and treatment outcome as measured by changes in depression, anxiety, and psychosocial functioning during the treatment period and up to the present will be collected. The investigators estimate that approximately 100 Veterans have been offered and/or provided DIT since 2012 by psychology trainees and staff. This study will provide preliminary data on the feasibility of implementing DIT treatment at the VA. The first trial of DIT for MDD in the VHA is currently being conducted by the PI and the information from the retrospective chart review would help to provide additional data as part of a proposal for a larger scale RCT of DIT.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Cory K Chen, PhD
  • Phone Number: 4002 212-686-7500
  • Email: cory.chen@va.gov

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Recruiting
        • VA New York Harbor Healthcare System
        • Contact:
          • Stanley John, MD
          • Phone Number: 4455 212-686-7500
        • Principal Investigator:
          • Cory K. Chen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Veterans that have received DIT treatment for clinically indicated depression and/or anxiety at VANYHHS (Manhattan) between 2012 to present.

Description

Inclusion Criteria:

- receive DIT treatment at VANYHHS between 2012-present

Exclusion Criteria:

- was not referred for, or did not receive at least 1 DIT session at VANYHHS between 2012-present

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: Total score collected at each weekly session of DIT, up to 16 weeks.; Scale: 0-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20-27: Severe Depression
The PHQ-9 is used to assess depressive symptom severity in patients.
Total score collected at each weekly session of DIT, up to 16 weeks.; Scale: 0-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20-27: Severe Depression
Generalized Anxiety Disorder Scale - 7 Item (GAD-7)
Time Frame: Total score collected at each weekly session of DIT, up to 16 weeks. Scale: 0-5: Mild Anxiety; 6-10: Moderate Anxiety; 11-15: Severe Anxiety
The GAD-7 is used to assess anxiety symptom severity in patients.
Total score collected at each weekly session of DIT, up to 16 weeks. Scale: 0-5: Mild Anxiety; 6-10: Moderate Anxiety; 11-15: Severe Anxiety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA New York Harbor Healthcare System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cory K Chen, PhD, VA New York Harbor Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VANYHH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Depression

Clinical Trials on Dynamic Interpersonal Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings