DepressionDITNCT03945136
Implementation of Brief Dynamic Interpersonal Therapy at the VA
An observational study of Depression and Anxiety, run by VA New York Harbor Healthcare System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Dynamic Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2016to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans that have received DIT treatment for clinically indicated depression and/or anxiety at VANYHHS (Manhattan) between 2012 to present.
Who may be able to join
- receive DIT treatment at VANYHHS between 2012-present
Who cannot join
- was not referred for, or did not receive at least 1 DIT session at VANYHHS between 2012-present
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA New York Harbor Healthcare System
New York, New York, 10010
Stanley John, MD, 212-686-7500 ext. 4455
Cory K. Chen, PhD
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Dynamic Interpersonal Therapy
- Keywords
- veterans, depression, anxiety, psychodynamic, psychotherapy, treatment
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Interpersonal TherapyBehavioural
Dynamic Interpersonal Therapy is a time-limited, manualized, interpersonal and affect-focused psychodynamic treatment that is frequently used to target depression and anxiety.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is used to assess depressive symptom severity in patients.
Measured: 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)
The GAD-7 is used to assess anxiety symptom severity in patients.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start15 Mar 2016
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Cory K. Chen, PhD, VA New York Harbor Healthcare System
- Investigators
- Cory K Chen, PhD, Principal investigator, VA New York Harbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945136
- Sponsor's protocol ID
- VANYHH
- Acronym
- DIT
- Status last verified
- Mar 2021
- First submitted
- 6 May 2019
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Brief Dynamic Interpersonal Therapy at the VA
- ClinicalTrials.gov ID
- NCT03945136
- Acronym / sponsor ID
- DIT / VANYHH
- Conditions
- Depression, Anxiety
- Keywords
- veterans, depression, anxiety, psychodynamic, psychotherapy, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans that have received DIT treatment for clinically indicated depression and/or anxiety at VANYHHS (Manhattan) between 2012 to present.
Key inclusion criteria (1 listed)
- receive DIT treatment at VANYHHS between 2012-present
Key exclusion criteria (1 listed)
- was not referred for, or did not receive at least 1 DIT session at VANYHHS between 2012-present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Interpersonal TherapyDynamic Interpersonal Therapy is a time-limited, manualized, interpersonal and affect-focused psychodynamic treatment that is frequently used to target depression and anxiety. | Behavioural | – |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cory K Chen, PhD principal investigator
VA New York Harbor Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by VA New York Harbor Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cory K Chen, PhD (212-686-7500 ext. 4002, cory.chen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.