Depression Clinical Trial
Official title:
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.
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. ;
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