Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of California, Davis.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard L. Kravitz, MD, MSPH, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01144104
First received: May 14, 2010
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

This trial consists of two linked substudies.

Substudy 1: Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study

Substudy 2: Activating Messages for Enhancing Primary Care Practice (AMEP2): Toxicity Study

The purpose of the Effectiveness Study is to assess the comparative effectiveness of three multimedia educational interventions (a targeted educational video, a tailored interactive multimedia computer program, and an "attention control") for increasing the likelihood that primary care patients with significant depressive symptoms will seek appropriate care (n = 510). The primary study outcomes are provision of minimally acceptable initial care, reductions in depression-related stigma, and improvement in depression symptoms. (See Process of Care and Patient Outcomes in Primary Outcome Measure section.)

The purpose of the Toxicity Study is to assess the potential benefits (reduced stigma) and harms (inappropriate prescribing) associated with three multimedia depression educational interventions when administered to patients with few or no depressive symptoms (n = 308). The primary outcomes relating to this outcome are reducing depression-related stigma and reducing unnecessary prescribing. (See Toxicity in Primary Outcome Measure section.)

Both studies will look at the secondary outcome measure of patient requests for depression treatment.


Condition Intervention
Depression
Behavioral: Demographically targeted public service announcements
Behavioral: Interactive Multi-Media Computer Program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Targeted and Tailored Messages to Enhance Depression Care

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Process of Care [ Time Frame: Within 24 hours of intervention delivery (physician post-visit assessment) ] [ Designated as safety issue: No ]
    Minimally acceptable initial care, meaning 1) antidepressant prescription, 2) referral to a mental health specialist, or 3) follow up within 14 days if PHQ >= 15 or within 30 days otherwise

  • Patient Outcomes [ Time Frame: Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks ] [ Designated as safety issue: No ]
    1) Stigma as measured by a scale adapted from Kanter JW, Rusch LC, Brondino MJ. Depression self-stigma: a new measure and preliminary findings. J Nervous Mental Dis 1008; 196(9):663-70, and 2) depression symptoms measured via PHQ-8 scores.

  • Toxicity [ Time Frame: Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit) ] [ Designated as safety issue: No ]
    1) Stigma as measured by a scale adapted from Kanter (see above) and 2) antidepressant prescribing by physician


Secondary Outcome Measures:
  • Direct or indirect patient requests for depression treatment [ Time Frame: Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit) ] [ Designated as safety issue: No ]
    Patient request for medicine for depression or referral to a mental health professional


Estimated Enrollment: 818
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Public Service Announcements
This arm includes four 2.5 minute public service announcements targeted to low-income men, low-income women, mid-income men, and mid-income women.
Behavioral: Demographically targeted public service announcements
Four public service announcements targeted to respondent's gender and income level
Experimental: Interactive Multi-Media Computer Program
This arm includes a personally tailored information about seeking care for depression based on respondent characteristics
Behavioral: Interactive Multi-Media Computer Program
This intervention displays personally tailored messages about seeking care for depressions based on responses to questions about stigma, disease orientation, and self-efficacy
No Intervention: Attention Control Video
This two-minute video focuses on common sleep disorders

Detailed Description:

This project is an investigator-initiated study involving two sequential phases and is funded by the National Institute of Mental Health. Phase I included the use of marketing research (i.e. focus groups, adaptive conjoint analysis, and other survey methods) to produce two clinic-based interventions: a public service announcement (PSA) and interactive multimedia computer program (IMCP). The two clinic-based interventions are intended to include messages that will activate patients to talk with their physicians about specific health concerns (depression) and/or any depressive symptoms they've been experiencing. In Phase II (as described in this registration protocol), those interventions will undergo assessment in a randomized controlled effectiveness trial (RCT) in primary care settings in Sacramento and San Francisco.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 25-70
  • Visual acuity and manual dexterity to operate a laptop computer

Exclusion Criteria:

  • Currently being treated for depression with anti-depressant medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144104

Locations
United States, California
Sutter Health - Elk Grove Family Medicine
Elk Grove, California, United States, 95758
VA Northern California Healthcare System
Mather, California, United States, 95655
Kaiser Permanente - Point West
Sacramento, California, United States, 95815
University of California, Davis
Sacramento, California, United States, 95817
San Francisco VA Medical Center
San Francisco, California, United States, 94121
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Richard L Kravitz, MD, MSPH University of California, Davis
Principal Investigator: Mitchell L Feldman, MD, MPhil University of California, San Francisco
  More Information

No publications provided by University of California, Davis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard L. Kravitz, MD, MSPH, Professor, Internal Medicine, University of California, Davis
ClinicalTrials.gov Identifier: NCT01144104     History of Changes
Other Study ID Numbers: 200917591-1, 1R01MH079387-01A1
Study First Received: May 14, 2010
Last Updated: December 6, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014