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

Depression Clinical Trial

— AMEP2  

Official title:

Targeted and Tailored Messages to Enhance Depression Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144104
• Other study ID #: 200917591
• Secondary ID: 1R01MH079387-01A
• Status: Completed
• Phase: N/A
• First received: May 14, 2010
• Last updated: May 25, 2017
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 925
• Est. completion date: June 2014
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Public Service Announcement

• Interactive Multi-Media Computer Program

• Sleep Hygiene Video

Locations

Country	Name	City	State
United States	Sutter Health - Elk Grove Family Medicine	Elk Grove	California
United States	VA Northern California Healthcare System	Mather	California
United States	Kaiser Permanente - Point West	Sacramento	California
United States	University of California, Davis	Sacramento	California
United States	San Francisco VA Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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)