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DepressionNCT02010866

Reaching Out to Distressed Medical Residents, Fellows and Faculty

A study testing counseling in people with Depression and Suicide, run by Oregon Health and Science University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to study whether distressed medical residents, fellows, and faculty health professionals benefit from completing online an anonymous and interactive screening of stress, depression, substance use, and suicidal thoughts. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Suicide
What is being tested?
counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
1 siteUnited States
Study dates
Jan 2014to Oct 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • OHSU medical residents, fellows, and full-time School of Medicine faculty

Who cannot join

  • individuals not meeting the above inclusion criteria

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marie V Soller, MD contact

503-494-9000

soller@ohsu.edu

Gillian Lashen, Ph.D. contact

503-494-9000

lashen@ohsu.edu

United States1 site, 1 recruiting
  • Oregon Health and Science University

    Portland, Oregon, 97239

    Liz Stevenson, JD, 503-494-6144, steveeli@ohsu.edu

    Marie V Soller, MD

    Recruiting

Other trials in United States

About this study

Official title: Reaching Out to Distressed Medical Residents, Fellows, and Faculty Through the OHSU Resident and Faculty Wellness Program Interactive Screening Program (ISP)

The purpose of this study is to study whether distressed medical residents, fellows, and faculty health professionals benefit from completing online an anonymous and interactive screening of stress, depression, substance use, and suicidal thoughts. The screening and ability to interact online with a clinician anonymously are hypothesized to increase willingness to come for counseling in person. Suicide risk factors are expected to be lower once the distressed medical trainee or faculty member receives treatment.

Read the detailed description

According to theories such as motivational interviewing and stages of change, individuals change health behaviors when the benefits (e.g., being less stressed) outweigh the risks (e.g., concerns about confidentiality of treatment). Prior research suggests that educational programming to promote the benefits and counter the perceived risks of counseling increases adults' motivation to get professional help. Distressed physicians' motivation to seek help following an educational intervention has not been evaluated but organizations such as the American Foundation for Suicide Prevention, Association for the Accreditation of Graduate Medical Education, and the American Medical Association have developed policies and programming to educate physicians about the importance of treating depression and reducing suicide risk in themselves and their colleagues.

A "best practices" suicide prevention program in 50+ US universities, the American Foundation for Suicide Prevention's Interactive Screening Program (ISP), was identified by the Oregon Health and Science University (OHSU) Resident and Faculty Wellness Program (RFWP) clinicians as a possible avenue by which to reach distressed OHSU trainees and faculty and encourage them to get help. The "Stress and Depression Questionnaire" is an anonymous, online screening tool for stress, depression, substance abuse, eating disorders, and suicide risk. Responses are scored and ranked according to level of distress and risk with Tier 1 representing "high risk, high distress" and Tier 2 "moderate distress, less risk" and Tier 3 "low or no distress or risk". RFWP clinicians will monitor responses, provide prompt communication back to the participants with information about how they scored, resources available to them, address any questions/concerns they might have and invite them to set up an appointment at the RFWP (if distressed). Moutier and her colleagues at a similar size academic medical center to OHSU, University of California at San Diego (UCSD), administered this survey to all medical students, residents, fellows, and faculty (13% completed it) and the majority eventually seen by clinicians indicated that they never would have sought help if they had not received feedback on the ISP and been encouraged to come in for evaluation/treatment. Being able to anonymously dialogue with a clinician about their specific situation and questions appeared to persuade some participants to come in for an evaluation or accept a referral. This academic medical center did not have an in-house counseling program for residents and faculty like the OHSU RFWP-UCSD trainees received an initial evaluation from a clinician and then were provided with community referrals. Their participation rate of 13% is similar to rates of participation in the ISP in undergraduate populations. In the present study, it is hypothesized that a highly visible and utilized RFWP may lead to a higher ISP participation rate among the residents, fellows, and faculty.

Although the ultimate goal is to save lives (i.e., reduce the rate of suicide among medical trainees and faculty), the low base rate of suicide in a population makes it difficult to evaluate whether the implementation of the ISP at OHSU will lead to a drop in suicide rates at this institution. Even using patient suicidal ideation and attempts as outcomes is problematic as this information can be difficult to gather unless the patient is actively involved in treatment at the time. Rather in the present study the effectiveness of this suicide prevention program will be measured by examining related variables to suicide risk-increases in protective factors and decreases in risk factors. Specifically, these researchers seek to decrease known risk factors (e.g., identify and intervene with untreated depression, substance abuse, high level of stress) and increase protective factors (e.g., promote self-awareness, receipt of support and resources and delivery of mental health services if needed).

Present study aims are to:

  • reduce known risk factors of untreated psychological distress (e.g., depression, high stress level, substance abuse) by encouraging all residents, fellows, and School of Medicine (SOM) faculty to complete a self-assessment of their level of stress and risk using the ISP and then offer professional help through a personalized message/dialogue that directly addresses any concerns/barriers about seeking help at the RFWP and offers resources for better coping;
  • increase self-awareness in mildly/moderately distressed trainees and faculty who fill out the ISP and offer preventive/early intervention educational resources via the ISP on topics that are relevant to them (based on their responses);
  • evaluate whether all RFWP patients (ones who come to the program via ISP and other referral sources) report decreased psychological distress, burnout, and risk of suicide across treatment;
  • assess levels of distress and flourishing among RFWP participants over time
  • assess level of satisfaction with the RFWP educational outreach workshops, consultation to department leaders (and referral of their trainees and/or faculty), and clinical services provided to distressed trainees and faculty.
Conditions
Depression, Suicide
Being tested
counseling
Keywords
internship and residency, physicians, prevention, counseling, suicide, depression, burnout
Medical subject headings
Depression, Suicide, Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • counselingBehavioural

    in-person counseling through RFWP offered to distressed respondents on the ISP and others who seek counseling (due to other reasons for referral)

Study groups in NCT02010866
Study groupRoleWhat they receive
CounselingOtherin-person counseling through RFWP to distressed respondents on the ISP and patients who seek counseling without completing the ISP
Receives: Behavioral: counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ISP levels of distress seen with medical trainees and faculty

    online, anonymous Interactive Screening Program (ISP) measures stress, depression, anxiety, substance abuse, and suicidal ideation--participants fill out survey at different points and may or may not come in for counseling

    Measured: Time survey is completed by trainee or faculty member at baseline

  2. Demographics of residents and faculty physicians who seek counseling through in house program

    Demographics of residents, faculty at time of intake for counseling at Resident and Faculty Wellness Program

    Measured: at enrollment for treatment (intake appointment)

  3. Who responds to treatment--level of distress

    % of participants in counseling services through Resident and Faculty Wellness who show change in psychological distress on ACORN from baseline to end of treatment

    Measured: time of intake (baseline) to participants' end of treatment or 6 months since last seen

  4. Who responds to treatment-level of burnout

    participants at Resident and Faculty Wellness Program who show significant decline in burnout on MBI screening items (emotional exhaustion and depersonalization items) from baseline (time of intake) to end of treatment

    Measured: time of intake to participants' end of treatment or 6 months since last seen

  5. Who responds to treatment-clinician rating of suicide risk

    participants of Resident and Faculty Wellness Program who show change in clinician rating of suicide risk during treatment

    Measured: time of intake (baseline) to participants end of treatment or 6 months since last seen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02010866
Sponsor's protocol ID
IRB 00009003
Status last verified
Apr 2024
First submitted
27 Nov 2013
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: will not be sharing data with other researchers outside of this project

Questions about this trial

What is this clinical trial studying?

A study testing counseling in people with Depression and Suicide, run by Oregon Health and Science University 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: looking for participants now, as of the sponsor's last update on 30 Apr 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie V Soller, MD (503-494-9000, soller@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ISP levels of distress seen with medical trainees and faculty (time frame: Time survey is completed by trainee or faculty member at baseline). The study lists 5 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 30 Apr 2024.

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