DepressionAMEP2NCT01144104
Activating Messages for Enhancing Primary Care Practice (AMEP2): Effectiveness Study
A study testing Public Service Announcement, Interactive Multi-Media Computer Program and Sleep Hygiene Video in people with Depression, run by University of California, Davis at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Public Service Announcement, Interactive Multi-Media Computer Program and Sleep Hygiene Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 925 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25-70
- Visual acuity and manual dexterity to operate a laptop computer
Who cannot join
- Currently being treated for depression with anti-depressant medications
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sutter Health - Elk Grove Family Medicine
Elk Grove, California, 95758
VA Northern California Healthcare System
Mather, California, 95655
Kaiser Permanente - Point West
Sacramento, California, 95815
University of California, Davis
Sacramento, California, 95817
San Francisco VA Medical Center
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
About this study
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
Read more
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Public Service Announcement, Interactive Multi-Media Computer Program, Sleep Hygiene Video
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Public Service AnnouncementBehavioural
Interactive Multi-Media Computer ProgramBehavioural
Sleep Hygiene VideoBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Public Service Announcements | Experimental | Demographically targeted public service announcement Receives: Behavioral: Public Service Announcement |
| Interactive Multi-Media Computer Program | Experimental | Personally tailored information about seeking care for depression based on respondent characteristics Receives: Behavioral: Interactive Multi-Media Computer Program |
| Attention Control Video | Active comparator | Two-minute video focusing on common sleep disorders. Receives: Behavioral: Sleep Hygiene Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 24 hours of intervention delivery (physician post-visit assessment)
Patient Outcomes
- 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.
Measured: Stigma: Within 24 hours of intervention delivery (patient post-visit assessment); depression symptoms: 12 weeks
Toxicity
- Stigma as measured by a scale adapted from Kanter (see above) and 2) antidepressant prescribing by physician
Measured: Within 24 hours of intervention delivery (patient and physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Secondary outcomes (1)
Direct or indirect patient requests for depression treatment
Patient request for medicine for depression or referral to a mental health professional
Measured: Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 925 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Richard L Kravitz, MD, MSPH, Principal investigator, University of California, DavisMitchell L Feldman, MD, MPhil, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144104
- Sponsor's protocol ID
- 200917591
- Other IDs
- 1R01MH079387-01A1
- Acronym
- AMEP2
- Status last verified
- May 2017
- First submitted
- 14 May 2010
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24193079Tancredi 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.
PubMed 23594572
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted and Tailored Messages to Enhance Depression Care
- ClinicalTrials.gov ID
- NCT01144104
- Acronym / sponsor ID
- AMEP2 / 200917591
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 925 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Public Service Announcements | Experimental | Behavioral: Public Service AnnouncementDemographically targeted public service announcement |
| Interactive Multi-Media Computer Program | Experimental | Behavioral: Interactive Multi-Media Computer ProgramPersonally tailored information about seeking care for depression based on respondent characteristics |
| Attention Control Video | Active comparator | Behavioral: Sleep Hygiene VideoTwo-minute video focusing on common sleep disorders. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 25-70
- Visual acuity and manual dexterity to operate a laptop computer
Key exclusion criteria (1 listed)
- Currently being treated for depression with anti-depressant medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Public Service Announcement | Behavioural | Public Service Announcements |
| Interactive Multi-Media Computer Program | Behavioural | Interactive Multi-Media Computer Program |
| Sleep Hygiene Video | Behavioural | Attention Control Video |
Primary outcome
Process of Care
Time frame: 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
Time frame: 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
Time frame: 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
1 secondary outcome
Direct or indirect patient requests for depression treatment
Time frame: Within 24 hours of intervention delivery (physician post-visit assessment, audio-recording of doctor-patient interaction at index visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 24193079Kravitz 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.
- Derived from this study: PubMed 23594572Tancredi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard L Kravitz, MD, MSPH principal investigator
University of California, Davis
Mitchell L Feldman, MD, MPhil principal investigator
University of California, San Francisco
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Public Service Announcement, Interactive Multi-Media Computer Program and Sleep Hygiene Video in people with Depression, run by University of California, Davis at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process of Care (time frame: Within 24 hours of intervention delivery (physician post-visit assessment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.