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

University of California (UC) Davis

Status: Completed

Conditions: Depression

Treatments: Behavioral: Public Service Announcement; Behavioral: Interactive Multi-Media Computer Program; Behavioral: Sleep Hygiene Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01144104

200917591

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 925 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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925 participants in 3 patient groups

Public Service Announcements

Experimental group

Description:

Demographically targeted public service announcement

Treatment:

Behavioral: Public Service Announcement

Interactive Multi-Media Computer Program

Experimental group

Description:

Personally tailored information about seeking care for depression based on respondent characteristics

Treatment:

Behavioral: Interactive Multi-Media Computer Program

Attention Control Video

Active Comparator group

Description:

Two-minute video focusing on common sleep disorders.

Treatment:

Behavioral: Sleep Hygiene Video