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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01144104
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE May 14, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE June 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
  • Process of Care [ Time Frame: Within 24 hours of intervention delivery (physician post-visit assessment) ]
    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 ]
    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) ]
    1) Stigma as measured by a scale adapted from Kanter (see above) and 2) antidepressant prescribing by physician
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2010)
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) ]
Patient request for medicine for depression or referral to a mental health professional
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
Official Title  ICMJE Targeted and Tailored Messages to Enhance Depression Care
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: Public Service Announcement
  • Behavioral: Interactive Multi-Media Computer Program
  • Behavioral: Sleep Hygiene Video
Study Arms  ICMJE
  • Experimental: Public Service Announcements
    Demographically targeted public service announcement
    Intervention: Behavioral: Public Service Announcement
  • Experimental: Interactive Multi-Media Computer Program
    Personally tailored information about seeking care for depression based on respondent characteristics
    Intervention: Behavioral: Interactive Multi-Media Computer Program
  • Active Comparator: Attention Control Video
    Two-minute video focusing on common sleep disorders.
    Intervention: Behavioral: Sleep Hygiene Video
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
925
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2010)
818
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144104
Other Study ID Numbers  ICMJE 200917591
1R01MH079387-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Richard L Kravitz, MD, MSPH University of California, Davis
Principal Investigator: Mitchell L Feldman, MD, MPhil University of California, San Francisco
PRS Account University of California, Davis
Verification Date May 2017

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