Depressive DisorderNCT04635748
Feasibility of Collateral Information Review and Its Impact on Clinical Decision-Making
An observational study of Depressive Disorder and Anxiety Disorders, run by Mclean Hospital at 1 site in United States.
Trial summary
This project will investigate how review of collateral information sources (CIS) may impact clinical decision-making across the lifespan. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Anxiety Disorders
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 14 Mar 2020
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: - Clinicians from McLean Hospital Outpatient Programs (geriatric, child and adult) and the McLean Behavioral Health Partial Program, which predominantly treat patients with mood disorders.
Who may be able to join
- Credentialed to provide psychopharmacology or psychotherapy at McLean and Licensed by the State of Massachusetts
- Practice pharmacotherapy and either adjunctive or stand-alone evidence-based psychotherapy (e.g., CBT, DBT, supportive psychotherapy, etc.)
- Fluent in English
Who cannot join
- Clinicians who do not meet the inclusion criteria detailed above
Trial locations and contacts
1 site in 1 country.
About this study
This project will investigate how review of collateral information sources (CIS) may impact clinical decision-making across the lifespan.
Read the detailed description
This study aims to explore how reviewing collateral information sources (CIS) may affect clinical decision-making for clinicians treating participants with varied mood disorders. Investigators will assess the types of collateral information used in the clinical setting and treatment decisions made after a clinical session. We will gather this information from interested clinicians who will provide this information after each patient visit over the course of one week.
- Conditions
- Depressive Disorder, Anxiety Disorders
- Medical subject headings
- Depressive Disorder, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
McLean Treatment Tracking Survey
Clinicians will find the McLean Treatment Tracking Survey easy to use in their clinical care and we will measure rate of use and completion.
Measured: Over the course of 1 week
Secondary outcomes (1)
Clinical Outcome - Increased treatment decisions made
Investigators will explore whether reviewing more collateral information sources leads to more clinical actions taken for treatment.
Measured: Over the course of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start3 Dec 2019
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Once Upon a Time Foundation
- Responsible party
- Principal investigator, Ipsit Vihang Vahia, Mclean Hospital
- Investigators
- Ipsit V Vahia, MD, Principal investigator, Mclean HospitalKerry J Ressler, MD; PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635748
- Sponsor's protocol ID
- 2019P003450
- Status last verified
- Oct 2021
- First submitted
- 13 Nov 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Collateral Information Review and Its Impact on Clinical Decision-Making
- ClinicalTrials.gov ID
- NCT04635748
- Acronym / sponsor ID
- 2019P003450
- Conditions
- Depressive Disorder, Anxiety Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Once Upon a Time Foundation
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 19 Nov 2020 (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.
This project will investigate how review of collateral information sources (CIS) may impact clinical decision-making across the lifespan.
Detailed description
This study aims to explore how reviewing collateral information sources (CIS) may affect clinical decision-making for clinicians treating participants with varied mood disorders. Investigators will assess the types of collateral information used in the clinical setting and treatment decisions made after a clinical session. We will gather this information from interested clinicians who will provide this information after each patient visit over the course of one week.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- - Clinicians from McLean Hospital Outpatient Programs (geriatric, child and adult) and the McLean Behavioral Health Partial Program, which predominantly treat patients with mood disorders.
Key inclusion criteria (3 listed)
- Credentialed to provide psychopharmacology or psychotherapy at McLean and Licensed by the State of Massachusetts
- Practice pharmacotherapy and either adjunctive or stand-alone evidence-based psychotherapy (e.g., CBT, DBT, supportive psychotherapy, etc.)
- Fluent in English
Key exclusion criteria (1 listed)
- Clinicians who do not meet the inclusion criteria detailed above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
McLean Treatment Tracking Survey
Time frame: Over the course of 1 week
Clinicians will find the McLean Treatment Tracking Survey easy to use in their clinical care and we will measure rate of use and completion.
1 secondary outcome
Clinical Outcome - Increased treatment decisions made
Time frame: Over the course of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
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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.
Ipsit V Vahia, MD principal investigator
Mclean Hospital
Kerry J Ressler, MD; PhD principal investigator
Mclean Hospital
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 Depressive Disorder and Anxiety Disorders, run by Mclean Hospital 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 3 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: finished, as of the sponsor's last update on 26 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
McLean Treatment Tracking Survey (time frame: Over the course of 1 week). 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 26 Oct 2021.