Suicidal IntentionNCT02986113
Men and Providers Preventing Suicide (MAPS)
A study testing MAPS tailored multimedia patient activation program, Sleep hygiene video and Telephone evidence-based follow-up care in people with Suicidal Intention and Suicidal Ideation, run by University of California, Davis at 2 sites in United States.
Trial summary
This study will determine if suicidal middle-aged men who use a personalized computer program addressing suicide risk before a primary care visit are more likely to discuss suicide and accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important because half of all men who die by… Read more about this study
- Who is it for?
- Ages 35 to 64 years, men only
- Conditions the study is for
- Suicidal Intention, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- MAPS tailored multimedia patient activation program, Sleep hygiene video and Telephone evidence-based follow-up care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to Sep 2019
- 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 35 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Self-identified male gender
- Aged 35-74
- Has a PCP at a primary care office in one of the two participating health systems who is actively enrolled in the RCT
- Active suicide thoughts within past 4 weeks
- Able to read and speak English; and self-reported adequate vision, hearing, and hand function to engage with an interactive computer program on a touchscreen electronic tablet device.
Who cannot join
- Reported or apparent highly unstable medical status (e.g. acute decompensated heart failure requiring immediate care)
- Reported or apparent highly unstable mental health status (e.g. acute uncontrolled psychosis)
- Presence of terminal illness with death anticipated within 3 months
- Plan to leave the current primary care office (e.g., transfer care) within 3 months
- Incarcerated
- Inability to understand and/or provide informed consent, following appropriate explanation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
University of California Davis Health System
Sacramento, California, 95817
About this study
Official title: Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial
This study will determine if suicidal middle-aged men who use a personalized computer program addressing suicide risk before a primary care visit are more likely to discuss suicide and accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important because half of all men who die by suicide visit primary care within a month of death, yet few broach the topic, missing chances for prevention.
Read the detailed description
In this study, the investigators will enroll middle-aged men with active suicide thoughts in a randomized controlled trial (RCT) to examine whether their use of the Men and Providers Preventing Suicide (MAPS) tailored interactive multimedia patient activation program immediately before a primary care provider (PCP) visit, linked with integrated telephone evidence-based follow-up care (TEBFC) (vs. attention control exposure linked with TEBFC), reduces suicide preparatory behaviors and ideation over 3 months. About half of all middle-aged men who die by suicide are seen by a PCP within a month of dying, suggesting the value of primary care-based suicide prevention efforts, to complement strategies in other settings. Current impediments to primary care-based prevention are that many suicidal middle-aged men do not visit a PCP, and among those who do the topic of suicide is rarely broached, due to societal gender-linked norms (e.g., toughness); stigma; spurious concerns that talking about suicide increases risk; competing time demands; and lack of resources to cope with positive responses. PCP-targeted educational interventions have increased detection of suicidal men, but have inconsistently affected suicide behaviors, and still many suicidal men went undetected. Suicide behaviors are more likely to be reduced by evidence-based follow-up care - supportive follow-up contact and collaborative mental health care. However, such care can only be effective if at-risk men visit a PCP who identifies suicide risk and offers the care, and the men accept it. Thus, there is a pressing need to study the use of innovative tools like MAPS to activate at risk middle-aged men to signal their receptiveness to suicide discussion and care, prompting PCP inquiry and referrals to a form of follow-up care that is feasible for most practices to implement (e.g., TEBFC).
- Conditions
- Suicidal Intention, Suicidal Ideation, Suicide, Attempted
- Being tested
- MAPS tailored multimedia patient activation program, Sleep hygiene video, Telephone evidence-based follow-up care, Commitment to Living for Primary Care
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAPS tailored multimedia patient activation programBehavioural
Sleep hygiene videoBehavioural
3 minute video on sleep hygiene produced by HealthiNation
Telephone evidence-based follow-up careBehavioural
Also called TEBFC
3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider
Commitment to Living for Primary CareBehavioural
Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention
| Study group | Role | What they receive |
|---|---|---|
| Men and Providers Preventing Suicide | Experimental | Tailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit Receives: Behavioral: MAPS tailored multimedia patient activation program; Behavioral: Telephone evidence-based follow-up care; Behavioral: Commitment to Living for Primary Care |
| Sleep hygiene video | Active comparator | A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk. Receives: Behavioral: Sleep hygiene video; Behavioral: Telephone evidence-based follow-up care; Behavioral: Commitment to Living for Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient: Beck Scale for Suicide Ideation
Measured: 3 months
Secondary outcomes (15)
Patient: Reported discussion of suicide during study visits
Measured: Immediately post-study visit
Patient: suicidal intent scale
Measured: 3 months
Patient: enrollment in telephone evidence-based follow-up care
Measured: Immediately post-study visit, 1 month, 2 months, 3 months
Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs
Measured: 1 month, 2 months, 3 months
Patient: Interpersonal Needs Questionnaire
Perceived burdensomeness and belongingness to others
Measured: 1 month, 2 months, 3 months
Patient: augmented Patient Health Questionnaire (PHQ-9)
PHQ-9 plus six "male depression" items
Measured: 1 month, 2 months, 3 months
Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
Mental health status
Measured: 1 month, 2 months, 3 months
Patient: SF-12 Physical Component Summary score
Physical health status
Measured: 1 month, 2 months, 3 months
Patient: Toughness scale
Gender-linked views regarding health-related help-seeking
Measured: 1 month, 2 months, 3 months
Patient: perceptions of the study interventions and trial participation questionnaire
Measured: 3 months
PCP: perceptions of baseline training videos questionnaire
Measured by questionnaire
Measured: Immediately after completing the video training
PCP: reported discussion of suicide during study visits
Measured: Immediately post-study visit
PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs
Measured: Through study completion, up to 3 years
PCP: attitudes toward caring for suicidal patients questionnaire
Measured: At study completion, up to 3 years
PCP: perceptions of study participation questionnaire
Measured: At study completion, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IntentionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Anthony Jerant, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986113
- Sponsor's protocol ID
- 922468
- Other IDs
- U01CE002664
- Status last verified
- Oct 2019
- First submitted
- 2 Dec 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jerant A, Duberstein PR, Kravitz RL, Kleiman EM, Rizvi SL, Cipri C, Liu D, Scher L, Freitas M, Jones-Hill M, Oravetz A, Van Orden KA, Franks P. Ethical and methodological challenges slowing progress in primary care-based suicide prevention: Illustrations from a randomized controlled trial and guidance for future research. J Psychiatr Res. 2022 Oct;154:242-251. doi: 10.1016/j.jpsychires.2022.07.038. Epub 2022 Aug 6.
PubMed 35961180
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02986113
- Acronym / sponsor ID
- 922468
- Conditions
- Suicidal Intention, Suicidal Ideation, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Dec 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 8 Dec 2016 (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 study will determine if suicidal middle-aged men who use a personalized computer program addressing suicide risk before a primary care visit are more likely to discuss suicide and accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important because half of all men who die by suicide visit primary care within a month of death, yet few broach the topic, missing chances for prevention.
Detailed description
In this study, the investigators will enroll middle-aged men with active suicide thoughts in a randomized controlled trial (RCT) to examine whether their use of the Men and Providers Preventing Suicide (MAPS) tailored interactive multimedia patient activation program immediately before a primary care provider (PCP) visit, linked with integrated telephone evidence-based follow-up care (TEBFC) (vs. attention control exposure linked with TEBFC), reduces suicide preparatory behaviors and ideation over 3 months. About half of all middle-aged men who die by suicide are seen by a PCP within a month of dying, suggesting the value of primary care-based suicide prevention efforts, to complement strategies in other settings. Current impediments to primary care-based prevention are that many suicidal middle-aged men do not visit a PCP, and among those who do the topic of suicide is rarely broached, due to societal gender-linked norms (e.g., toughness); stigma; spurious concerns that talking about suicide increases risk; competing time demands; and lack of resources to cope with positive responses. PCP-targeted educational interventions have increased detection of suicidal men, but have inconsistently affected suicide behaviors, and still many suicidal men went undetected. Suicide behaviors are more likely to be reduced by evidence-based follow-up care - supportive follow-up contact and collaborative mental health care. However, such care can only be effective if at-risk men visit a PCP who identifies suicide risk and offers the care, and the men accept it. Thus, there is a pressing need to study the use of innovative tools like MAPS to activate at risk middle-aged men to signal their receptiveness to suicide discussion and care, prompting PCP inquiry and referrals to a form of follow-up care that is feasible for most practices to implement (e.g., TEBFC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men and Providers Preventing Suicide | Experimental | Behavioral: MAPS tailored multimedia patient activation program, Behavioral: Telephone evidence-based follow-up care, Behavioral: Commitment to Living for Primary CareTailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit |
| Sleep hygiene video | Active comparator | Behavioral: Sleep hygiene video, Behavioral: Telephone evidence-based follow-up care, Behavioral: Commitment to Living for Primary CareA brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-identified male gender
- Aged 35-74
- Has a PCP at a primary care office in one of the two participating health systems who is actively enrolled in the RCT
- Active suicide thoughts within past 4 weeks
- Able to read and speak English; and self-reported adequate vision, hearing, and hand function to engage with an interactive computer program on a touchscreen electronic tablet device.
Key exclusion criteria (6 listed)
- Reported or apparent highly unstable medical status (e.g. acute decompensated heart failure requiring immediate care)
- Reported or apparent highly unstable mental health status (e.g. acute uncontrolled psychosis)
- Presence of terminal illness with death anticipated within 3 months
- Plan to leave the current primary care office (e.g., transfer care) within 3 months
- Incarcerated
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 |
|---|---|---|
| MAPS tailored multimedia patient activation program | Behavioural | Men and Providers Preventing Suicide |
| Sleep hygiene video3 minute video on sleep hygiene produced by HealthiNation | Behavioural | Sleep hygiene video |
| Telephone evidence-based follow-up careAlso: TEBFC3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider | Behavioural | Men and Providers Preventing Suicide, Sleep hygiene video |
| Commitment to Living for Primary CareBrief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention | Behavioural | Men and Providers Preventing Suicide, Sleep hygiene video |
Primary outcome
Patient: Beck Scale for Suicide Ideation
Time frame: 3 months
15 secondary outcomes
Patient: Reported discussion of suicide during study visits
Time frame: Immediately post-study visit
Patient: suicidal intent scale
Time frame: 3 months
Patient: enrollment in telephone evidence-based follow-up care
Time frame: Immediately post-study visit, 1 month, 2 months, 3 months
Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs
Time frame: 1 month, 2 months, 3 months
Patient: Interpersonal Needs Questionnaire
Time frame: 1 month, 2 months, 3 months
Patient: augmented Patient Health Questionnaire (PHQ-9)
Time frame: 1 month, 2 months, 3 months
Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
Time frame: 1 month, 2 months, 3 months
Patient: SF-12 Physical Component Summary score
Time frame: 1 month, 2 months, 3 months
Patient: Toughness scale
Time frame: 1 month, 2 months, 3 months
Patient: perceptions of the study interventions and trial participation questionnaire
Time frame: 3 months
PCP: perceptions of baseline training videos questionnaire
Time frame: Immediately after completing the video training
PCP: reported discussion of suicide during study visits
Time frame: Immediately post-study visit
PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs
Time frame: Through study completion, up to 3 years
PCP: attitudes toward caring for suicidal patients questionnaire
Time frame: At study completion, up to 3 years
PCP: perceptions of study participation questionnaire
Time frame: At study completion, up to 3 years
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 Oct 2019.
- Derived from this study: PubMed 35961180Jerant A, Duberstein PR, Kravitz RL, Kleiman EM, Rizvi SL, Cipri C, Liu D, Scher L, Freitas M, Jones-Hill M, Oravetz A, Van Orden KA, Franks P. Ethical and methodological challenges slowing progress in primary care-based suicide prevention: Illustrations from a randomized controlled trial and guidance for future research. J Psychiatr Res. 2022 Oct;154:242-251. doi: 10.1016/j.jpsychires.2022.07.038. Epub 2022 Aug 6.
- Individual participant dataSharing planned: No
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.
Anthony Jerant, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAPS tailored multimedia patient activation program, Sleep hygiene video and Telephone evidence-based follow-up care in people with Suicidal Intention and Suicidal Ideation, run by University of California, Davis at 2 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 5 inclusion and 6 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Patient: Beck Scale for Suicide Ideation (time frame: 3 months). 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 NCT02986113, which also lists 1 linked publication.
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 Oct 2019.