- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03945136
Implementation of Brief Dynamic Interpersonal Therapy at the VA (DIT)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Cory K Chen, PhD
- Phone Number: 4002 212-686-7500
- Email: cory.chen@va.gov
Study Contact Backup
- Name: Lauren Wash, MA
- Phone Number: 3003 212-686-7500
- Email: lauren.wash@va.gov
Study Locations
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
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
Investigators
- Principal Investigator: Cory K Chen, PhD, VA New York Harbor Healthcare System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- VANYHH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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