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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03945136
Other study ID # VANYHH
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2016
Est. completion date December 31, 2022

Study information

Verified date March 2021
Source VA New York Harbor Healthcare System
Contact Cory K Chen, PhD
Phone 212-686-7500
Email cory.chen@va.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Dynamic Interpersonal Therapy
Dynamic Interpersonal Therapy is a time-limited, manualized, interpersonal and affect-focused psychodynamic treatment that is frequently used to target depression and anxiety.

Locations

Country Name City State
United States VA New York Harbor Healthcare System New York New York

Sponsors (1)

Lead Sponsor Collaborator
VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Health Questionnaire (PHQ-9) 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
Primary Generalized Anxiety Disorder Scale - 7 Item (GAD-7) 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
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