Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
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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 |
- 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
- 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 |
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| 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 | |
| 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 June 18, 2013