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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Targeted and Tailored Messages to Enhance Depression Care

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Public Service Announcement
* Behavioral: Interactive Multi-Media Computer Program
* Behavioral: Sleep Hygiene Video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Process of Care | 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 | 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 | 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 | 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) |