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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH079387-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Public Service Announcements | Experimental | Demographically targeted public service announcement |
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| Interactive Multi-Media Computer Program | Experimental | Personally tailored information about seeking care for depression based on respondent characteristics |
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| Attention Control Video | Active Comparator | Two-minute video focusing on common sleep disorders. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Public Service Announcement | Behavioral |
| ||
| Interactive Multi-Media Computer Program |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Kravitz, MD, MSPH | University of California, Davis | Principal Investigator |
| Mitchell L Feldman, MD, MPhil | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Health - Elk Grove Family Medicine | Elk Grove | California | 95758 | United States | ||
| VA Northern California Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24193079 | Derived | Kravitz RL, Franks P, Feldman MD, Tancredi DJ, Slee CA, Epstein RM, Duberstein PR, Bell RA, Jackson-Triche M, Paterniti DA, Cipri C, Iosif AM, Olson S, Kelly-Reif S, Hudnut A, Dvorak S, Turner C, Jerant A. Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial. JAMA. 2013 Nov 6;310(17):1818-28. doi: 10.1001/jama.2013.280038. | |
| 23594572 | Derived | Tancredi DJ, Slee CK, Jerant A, Franks P, Nettiksimmons J, Cipri C, Gottfeld D, Huerta J, Feldman MD, Jackson-Triche M, Kelly-Reif S, Hudnut A, Olson S, Shelton J, Kravitz RL. Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study. BMC Health Serv Res. 2013 Apr 17;13:141. doi: 10.1186/1472-6963-13-141. |
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| Behavioral |
|
| Sleep Hygiene Video | Behavioral |
|
| Mather |
| California |
| 95655 |
| United States |
| Kaiser Permanente - Point West | Sacramento | California | 95815 | United States |
| University of California, Davis | Sacramento | California | 95817 | United States |
| San Francisco VA Medical Center | San Francisco | California | 94121 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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