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

May 25, 2017 updated by: University of California, Davis

Targeted and Tailored Messages to Enhance Depression Care

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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Interventional

Enrollment (Actual)

925

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Elk Grove, California, United States, 95758
        • Sutter Health - Elk Grove Family Medicine
      • Mather, California, United States, 95655
        • VA Northern California Healthcare System
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • Sacramento, California, United States, 95815
        • Kaiser Permanente - Point West
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Public Service Announcements
Demographically targeted public service announcement
Behavioral: Public Service Announcement
Experimental: Interactive Multi-Media Computer Program
Personally tailored information about seeking care for depression based on respondent characteristics
Behavioral: Interactive Multi-Media Computer Program
Active Comparator: Attention Control Video
Two-minute video focusing on common sleep disorders.
Behavioral: Sleep Hygiene Video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 24 hours of intervention delivery (physician post-visit assessment)
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.
Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks
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
Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mitchell L Feldman, MD, MPhil, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 14, 2010

First Submitted That Met QC Criteria

June 10, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 25, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200917591
  • 1R01MH079387-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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