DepressionNCT01618552
Training Doctors to Support Patient Self-Care of Depression
A study testing SEE IT training and Knowledge enhancement in people with Depression and Diabetes, run by University of California, Davis at 2 sites in United States.
Trial summary
This study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Diabetes
- What is being tested?
- SEE IT training and Knowledge enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to May 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Physicians (targeted enrollment=56; actual enrollment=50)
- Currently in practice at a participating office within one of the 2 participating health systems (University of California Davis Primary Care Network, Sutter Sacramento Health System)
- Trained as a family physician, general practitioner, and/or general internist
- Able to read and speak English
Inclusion Criteria: Group of patients with diabetes and depressive symptoms (targeted enrollment=168; actual enrollment=15)
- Receive primary health care in one of the participating offices, from one of the participating primary care physicians
- Aged 18 years or older
- Able to read and speak English
- Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
- Have concurrent diagnoses of depression and diabetes, determined via medical record review
- Have at least mild depressive symptoms, manifested by a score of 10 or greater on a telephone-administered Patient Health Questionnaire (PHQ-9).
- Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
- Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider
Inclusion Criteria: Group of patients with various health conditions, ie, not limited to diabetes and depression (targeted enrollment=336; actual enrollment=117)
- Receive primary health care in one of the participating offices, from one of the participating primary care physicians
- Aged 18 years or older
- Able to read and speak English
- Self-report of adequate vision, hearing, and hand function to complete self-administered questionnaires on a touch screen notebook computer
- Have an office visit scheduled with their assigned primary care provider within 1 month of study eligibility screening
- Made 2 or more of their primary care office visits during the preceding year with their assigned primary care provider
Exclusion Criteria: Patients (applies to all study patients)
- Self-report or medical record evidence of unstable overall medical status
- Self-report or medical record evidence of terminal illness
- Self-report or medical record evidence of bipolar disorder, chronic psychosis (schizophrenia or other), or personality disorder
- Self-report or medical record evidence of a history of attempted suicide
- Planned transfer of care to a health system other than the 2 participating systems within 6 months
- Inability to understand any of the screening questions, after appropriate explanation (e.g. due to cognitive impairment, developmental delay, or other reasons)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sutter Health Sacramento
Sacramento, California, 95816
University of California Davis Health System
Sacramento, California, 95817
About this study
Official title: Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors
This study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to patients with health conditions other than depression and diabetes. This is important because most patients with chronic conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.
Read the detailed description
Many primary care patients struggle with health behaviors that can reduce depressive symptoms, such as adhering to prescribed treatments. Bolstering patient self-efficacy can improve health behaviors and outcomes, including those related to depression. However, current self-efficacy interventions are provided outside of primary care, and so cannot harness the power of therapeutic primary care provider (PCP)-patient relationships. Teaching PCPs to employ self-efficacy enhancing interviewing techniques (SEE IT) with patients would build upon existing therapeutic relationships, greatly increasing the reach of self-efficacy enhancement. The randomized controlled trial (RCT) in this proposal will examine whether, as compared with an attention control condition, a brief (< 1 hour) office-based intervention for practicing PCPs will lead to significantly greater use of SEE IT during unannounced follow-up SP encounters (postintervention and 3 months). The interventions will be delivered to PCPs during their regular office hours by standardized patient (SP) instructors. All study SPs will portray patients with both depression and diabetes, since these conditions commonly co-occur and entail a heavy burden of health-enhancing behaviors. Exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with co-occurring depression and diabetes: self-efficacy for depression and diabetes self-care, actual self-care behaviors (e.g. medication adherence), symptom severity, and health status. Further exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with various chronic conditions (ie, not limited to depression and diabetes): self-care self-efficacy, actual self-care behaviors, symptom severity, and health status. Pre- and post-RCT focus groups with stakeholders (PCPs, office staff, patients, and SP instructors) will guide refinement of the SEE IT intervention. The proposed research activities will inform the design (e.g. sample size) and conduct of a future R01-funded, multi-center, cluster RCT of the finalized intervention, adequately powered to examine effects on a range of patient outcomes; sustainability of effects on PCP interviewing over time; and generalizability to other practice settings and common co-morbid mental health and physical illness clusters. The SEE IT intervention begins to address the broader health needs of individuals with depression in primary care, and has unique potential to reduce the tremendous burden of mental illness related morbidity and mortality.
- Conditions
- Depression, Diabetes
- Being tested
- SEE IT training, Knowledge enhancement
- Keywords
- Chronic disease, Cluster randomization, Comorbidity, Depression, Diabetes, Medical history taking, Office visits, Patient acceptance of health care, Patient compliance, Patient simulation, Physician patient relations, Primary health care, Randomized controlled trials, Self care, Self efficacy
- Medical subject headings
- Depression, Diabetes Mellitus, Chronic Disease, Patient Acceptance of Health Care, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEE IT trainingBehavioural
Standardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes
Knowledge enhancementOther
Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
| Study group | Role | What they receive |
|---|---|---|
| SEE IT training (interviewing skills) | Experimental | Intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes Receives: Behavioral: SEE IT training |
| Control (knowledge enhancement) | Active comparator | Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes Receives: Other: Knowledge enhancement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician use of self-efficacy enhancing interviewing techniques
Measured: During the 3 months after receiving intervention
Secondary outcomes (15)
Patient self-efficacy for depression self-care
Measured: 5 minutes after an index visit with primary provider
Patient self-efficacy for diabetes self-care
Measured: 5 minutes after an index visit with primary provider
General self-care self-efficacy (all health conditions)
Measured: 5 minutes after an index visit with primary provider
Patient depressive symptoms
Measured: 3 months after an index visit with their primary care provider
Patient depression self-care behaviors
Measured: 3 months after an index visit with their primary care provider
Patient diabetes self-care behaviors
Measured: 3 months after an index visit with their primary care provider
Patient chronic illness self-care behaviors (generic)
Measured: 3 months after an index visit with their primary care provider
Patient adherence to depression and diabetes medications
Measured: 3 months after an index visit with their primary care provider
Patient adherence to chronic illness medications (generic)
Measured: 3 months after an index visit with their primary care provider
Patient adherence to depression counseling
Measured: 3 months after an index visit with their primary care provider
Patient mental health status
Measured: 3 months after an index visit with their primary care provider
Patient physical health status
Measured: 3 months after an index visit with their primary care provider
Patient glycemic control
Measured: 3 months after an index visit with their primary care provider
Wallston Multidimensional Health Locus of Control Scale
Perceived control over health
Measured: 5 minutes after an index visit with their primary care provider
Healthcare Climate Questionnaire
Patient perception of degree to which primary care provider is autonomy supportive
Measured: 5 minutes after an index visit with their primary care provider
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Anthony Jerant, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618552
- Sponsor's protocol ID
- 2012336397-1
- Other IDs
- R34MH095893
- Status last verified
- Nov 2015
- First submitted
- 8 May 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jerant A, Kravitz RL, Azari R, White L, Garcia JA, Vierra H, Virata MC, Franks P. Training residents to employ self-efficacy-enhancing interviewing techniques: randomized controlled trial of a standardized patient intervention. J Gen Intern Med. 2009 May;24(5):606-13. doi: 10.1007/s11606-009-0946-4. Epub 2009 Mar 19.
PubMed 19296179Jerant A, Kravitz RL, Tancredi D, Paterniti DA, White L, Baker-Nauman L, Evans-Dean D, Villarreal C, Ried L, Hudnut A, Franks P. Training Primary Care Physicians to Employ Self-Efficacy-Enhancing Interviewing Techniques: Randomized Controlled Trial of a Standardized Patient Intervention. J Gen Intern Med. 2016 Jul;31(7):716-22. doi: 10.1007/s11606-016-3644-z. Epub 2016 Mar 8.
PubMed 26956140
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Training to Support Patient Self-Efficacy for Depression Care Behaviors
- ClinicalTrials.gov ID
- NCT01618552
- Acronym / sponsor ID
- 2012336397-1
- Conditions
- Depression, Diabetes
- Keywords
- Chronic disease, Cluster randomization, Comorbidity, Depression, Diabetes, Medical history taking, Office visits, Patient acceptance of health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Jun 2012 (estimated)
- 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 study will determine whether practicing primary care providers (PCPs) can be trained to support patient self-care of depression and co-existing diabetes during office visits, and begin to explore whether this might improve depression and diabetes outcomes, and whether the effects of the training generalize to patients with health conditions other than depression and diabetes. This is important because most patients with chronic conditions struggle with self-care and are seen in primary care, yet PCPs are seldom trained to support self-care.
Detailed description
Many primary care patients struggle with health behaviors that can reduce depressive symptoms, such as adhering to prescribed treatments. Bolstering patient self-efficacy can improve health behaviors and outcomes, including those related to depression. However, current self-efficacy interventions are provided outside of primary care, and so cannot harness the power of therapeutic primary care provider (PCP)-patient relationships. Teaching PCPs to employ self-efficacy enhancing interviewing techniques (SEE IT) with patients would build upon existing therapeutic relationships, greatly increasing the reach of self-efficacy enhancement. The randomized controlled trial (RCT) in this proposal will examine whether, as compared with an attention control condition, a brief (< 1 hour) office-based intervention for practicing PCPs will lead to significantly greater use of SEE IT during unannounced follow-up SP encounters (postintervention and 3 months). The interventions will be delivered to PCPs during their regular office hours by standardized patient (SP) instructors. All study SPs will portray patients with both depression and diabetes, since these conditions commonly co-occur and entail a heavy burden of health-enhancing behaviors. Exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with co-occurring depression and diabetes: self-efficacy for depression and diabetes self-care, actual self-care behaviors (e.g. medication adherence), symptom severity, and health status. Further exploratory (due to limited statistical power) analyses will explore intervention effects on the following outcomes among real patients with various chronic conditions (ie, not limited to depression and diabetes): self-care self-efficacy, actual self-care behaviors, symptom severity, and health status. Pre- and post-RCT focus groups with stakeholders (PCPs, office staff, patients, and SP instructors) will guide refinement of the SEE IT intervention. The proposed research activities will inform the design (e.g. sample size) and conduct of a future R01-funded, multi-center, cluster RCT of the finalized intervention, adequately powered to examine effects on a range of patient outcomes; sustainability of effects on PCP interviewing over time; and generalizability to other practice settings and common co-morbid mental health and physical illness clusters. The SEE IT intervention begins to address the broader health needs of individuals with depression in primary care, and has unique potential to reduce the tremendous burden of mental illness related morbidity and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEE IT training (interviewing skills) | Experimental | Behavioral: SEE IT trainingIntervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) with patients who have coexisting depression and diabetes |
| Control (knowledge enhancement) | Active comparator | Other: Knowledge enhancementBrief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SEE IT trainingStandardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes | Behavioural | SEE IT training (interviewing skills) |
| Knowledge enhancementBrief video clip designed to increase primary care physician awareness of new medication treatments for diabetes | Other | Control (knowledge enhancement) |
Primary outcome
Physician use of self-efficacy enhancing interviewing techniques
Time frame: During the 3 months after receiving intervention
15 secondary outcomes
Patient self-efficacy for depression self-care
Time frame: 5 minutes after an index visit with primary provider
Patient self-efficacy for diabetes self-care
Time frame: 5 minutes after an index visit with primary provider
General self-care self-efficacy (all health conditions)
Time frame: 5 minutes after an index visit with primary provider
Patient depressive symptoms
Time frame: 3 months after an index visit with their primary care provider
Patient depression self-care behaviors
Time frame: 3 months after an index visit with their primary care provider
Patient diabetes self-care behaviors
Time frame: 3 months after an index visit with their primary care provider
Patient chronic illness self-care behaviors (generic)
Time frame: 3 months after an index visit with their primary care provider
Patient adherence to depression and diabetes medications
Time frame: 3 months after an index visit with their primary care provider
Patient adherence to chronic illness medications (generic)
Time frame: 3 months after an index visit with their primary care provider
Patient adherence to depression counseling
Time frame: 3 months after an index visit with their primary care provider
Patient mental health status
Time frame: 3 months after an index visit with their primary care provider
Patient physical health status
Time frame: 3 months after an index visit with their primary care provider
Patient glycemic control
Time frame: 3 months after an index visit with their primary care provider
Wallston Multidimensional Health Locus of Control Scale
Time frame: 5 minutes after an index visit with their primary care provider
Healthcare Climate Questionnaire
Time frame: 5 minutes after an index visit with their primary care provider
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 2 Dec 2015.
- Background: PubMed 19296179Jerant A, Kravitz RL, Azari R, White L, Garcia JA, Vierra H, Virata MC, Franks P. Training residents to employ self-efficacy-enhancing interviewing techniques: randomized controlled trial of a standardized patient intervention. J Gen Intern Med. 2009 May;24(5):606-13. doi: 10.1007/s11606-009-0946-4. Epub 2009 Mar 19.
- Derived from this study: PubMed 26956140Jerant A, Kravitz RL, Tancredi D, Paterniti DA, White L, Baker-Nauman L, Evans-Dean D, Villarreal C, Ried L, Hudnut A, Franks P. Training Primary Care Physicians to Employ Self-Efficacy-Enhancing Interviewing Techniques: Randomized Controlled Trial of a Standardized Patient Intervention. J Gen Intern Med. 2016 Jul;31(7):716-22. doi: 10.1007/s11606-016-3644-z. Epub 2016 Mar 8.
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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.
Anthony Jerant, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEE IT training and Knowledge enhancement in people with Depression and Diabetes, run by University of California, Davis at 2 sites 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?
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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Physician use of self-efficacy enhancing interviewing techniques (time frame: During the 3 months after receiving intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618552, which also lists 2 linked publications.
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 2 Dec 2015.