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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Sleep Hygiene Video; Behavioral: Interactive Multi-Media Computer Program; Behavioral: Public Service Announcement

• Registration Number: NCT01144104
• Lead Sponsor: University of California, Davis

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-05-14
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-15
• Primary Completion: 2011-11
• Study Completion: 2014-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 925

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Process of Care	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
Patient Outcomes	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.
Toxicity	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

Secondary Outcome Measures

Name	Time	Method
Direct or indirect patient requests for depression treatment	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

Trial Locations

Locations (6)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of California, Davis; 🇺🇸 Sacramento, California, United States

Sutter Health - Elk Grove Family Medicine; 🇺🇸 Elk Grove, California, United States

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Kaiser Permanente - Point West; 🇺🇸 Sacramento, California, United States

VA Northern California Healthcare System; 🇺🇸 Mather, California, United States