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Training Doctors to Support Patient Self-Care of Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01618552
First received: May 8, 2012
Last updated: November 30, 2015
Last verified: November 2015

May 8, 2012
November 30, 2015
April 2013
February 2015   (final data collection date for primary outcome measure)
Physician use of self-efficacy enhancing interviewing techniques [ Time Frame: During the 3 months after receiving intervention ] [ Designated as safety issue: No ]
Physician use of self-efficacy enhancing interviewing techniques [ Time Frame: 3 months after receiving intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01618552 on ClinicalTrials.gov Archive Site
  • Patient self-efficacy for depression self-care [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • Patient self-efficacy for diabetes self-care [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • General self-care self-efficacy (all health conditions) [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • Patient depressive symptoms [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient depression self-care behaviors [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient diabetes self-care behaviors [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient chronic illness self-care behaviors (generic) [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to depression and diabetes medications [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to chronic illness medications (generic) [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to depression counseling [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient mental health status [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient physical health status [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient glycemic control [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Wallston Multidimensional Health Locus of Control Scale [ Time Frame: 5 minutes after an index visit with their primary care provider ] [ Designated as safety issue: No ]
    Perceived control over health
  • Healthcare Climate Questionnaire [ Time Frame: 5 minutes after an index visit with their primary care provider ] [ Designated as safety issue: No ]
    Patient perception of degree to which primary care provider is autonomy supportive
  • Patient self-efficacy for depression self-care [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • Patient self-efficacy for diabetes self-care [ Time Frame: 5 minutes after an index visit with primary provider ] [ Designated as safety issue: No ]
  • Patient depressive symptoms [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient depression self-care behaviors [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient diabetes self-care behaviors [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to depression and diabetes medications [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient adherence to depression counseling [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient mental health status [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient physical health status [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Patient glycemic control [ Time Frame: 3 months after an index visit with their primary care provider ] [ Designated as safety issue: No ]
  • Physician use of self-efficacy enhancing interviewing techniques [ Time Frame: Within 1 month of receiving intervention ] [ Designated as safety issue: No ]
  • Patient self-efficacy for depression self-care [ Time Frame: 3 months after the index visit with provider ] [ Designated as safety issue: No ]
  • Patient self-efficacy for diabetes self-care [ Time Frame: 3 months after the index visit with provider ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Training Doctors to Support Patient Self-Care of Depression
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Diabetes
  • Behavioral: SEE IT training
    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
  • Other: Knowledge enhancement
    Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
  • Experimental: SEE IT training (interviewing skills)
    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
    Intervention: Behavioral: SEE IT training
  • Active Comparator: Control (knowledge enhancement)
    Brief video clip designed to increase primary care physician awareness of new medication treatments for patients with diabetes
    Intervention: Other: Knowledge enhancement
Jerant A, Kravitz RL, Azari R, White L, García 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
May 2015
February 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01618552
2012336397-1, R34MH095893
Yes
Not Provided
Not Provided
University of California, Davis
University of California, Davis
National Institute of Mental Health (NIMH)
Principal Investigator: Anthony Jerant, MD University of California, Davis
University of California, Davis
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP