SuicideNMN_SSIPNCT01924936
Now Matters Now: An Online Suicide Prevention Program
A study testing DBT Online Program in people with Suicide and Suicide, Attempted, run by Kaiser Permanente at 1 site in United States.
Trial summary
In the United States in 2010, 38,000 people died from suicide and it is our nation's 10 leading cause of death. Suicide prevention is a national priority and yet secondary prevention programs targeting those most at risk are lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- DBT Online Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Group Health members who are ID verified for secure email messaging
- Age 18 or older
- Results of PHQ assessment completed with a medical provider (Group Health primary care or mental health) as part of ongoing care indicate increased risk for self-injury (item 9, 2 or 3 response)
Who cannot join
- 1. Patient has had a recent self-injury (past 60 days), as a more traditional clinical intervention would be more appropriate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98102
About this study
Official title: Pilot Study of Online Interventions for Population-based Suicide
In the United States in 2010, 38,000 people died from suicide and it is our nation's 10 leading cause of death. Suicide prevention is a national priority and yet secondary prevention programs targeting those most at risk are lacking. The purpose of the current research is to develop and pilot test three promising suicide prevention programs that, if found acceptable to high-risk individuals, could be further evaluated and eventually offered broadly and affordably to the public.
Read the detailed description
Reducing the risk of suicide attempt and suicide is a public health priority. There has been no substantial decrease in suicide for the past two decades. Prevention efforts to date have focused on primary (e.g. public service announcements) and tertiary (e.g. interventions following suicide attempt) methods. Secondary or indicated prevention has been relatively unexplored. Secondary prevention requires both accurate screening methods and effective interventions. These essential elements are now available. Our recent research demonstrates that responses to the suicidal ideation item of the PHQ depression scale are a powerful predictor of subsequent suicide attempt and death. Availability of the PHQ in electronic medical records creates an opportunity for accurate population-level screening. Dialectical behavior therapy (DBT) has strong evidence of tertiary efficacy for preventing suicide attempts in clinical populations. Brief outreach tertiary interventions such as caring messages have some evidence for preventing suicide attempts. These clinical or tertiary prevention interventions provide the best available evidence for use in building secondary prevention programs. Resulting programs could then be linked to population-level screening data in electronic medical records. The first goal of the research plan is to adapt DBT and caring messages to fit delivery models suitable for the large numbers of at-risk patients identifiable in healthcare settings. The second goal is to evaluate the feasibility, acceptability, and safety of these alternative online suicide and self-injury secondary prevention programs. Online delivery models are suitable because they are scalable and can be provided securely, cheaply, and utilizing existing systems in healthcare. Three brief online interventions will be evaluated: caring email (CE); CE + DBT online program; and CE + DBT online program + coach. Each intervention will supplement usual care among high- risk patients identified via PHQ depression scales collected at outpatient primary care and mental health visits. Intervention content will be drawn from the principles of DBT and caring messages. The study design will be additive in order to examine alternative intervention models that vary widely in resources required for large- scale delivery. However, these interventions will require vastly fewer resources than in-person or telephone interventions. The project will involve intervention feasibility (pretesting, N=60) and acceptability and safety testing (pilot, N=400). Acceptability wll be assessed by patient intervention engagement levels (requiring the large pilot sample) and qualitative/formative intervention feedback from patients. Safety will be assessed via rates of psychiatric hospitalizations and self-injury diagnoses in the medical record in the intervention conditions compared to those receiving just continued usual care. Results of the pilot study will inform the design of a full-scale effectiveness trial examining the impact of one or more of these interventions on risk of suicide attempt and/or suicide death.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Being tested
- DBT Online Program
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT Online ProgramBehavioural
DBT online program involving three DBT skills taught across three lessons. The DBT online program will be based on a brief DBT skills intervention previously developed and pilot tested by Dr. Whiteside. This DBT online program will provide far greater clinical intensity than Intervention 1 and will be delivered with a widely-used modular software platform suitable for an R-34 project.
| Study group | Role | What they receive |
|---|---|---|
| Placebo comparator | Caring email (based on the caring letters literature) sent via secure email messaging. Of the interventions, it is by far the most minimal in clinical intensity and human resources needs for delivery. Receives: Behavioral: DBT Online Program | |
| DBT program | Experimental | DBT online program involving three DBT skills taught across three lessons. The DBT online program will be based on a brief DBT skills intervention previously developed and pilot tested by Dr. Whiteside. This DBT online program will provide far greater clinical intensity than Intervention 1 and will be delivered with a widely-used modular software platform suitable for an R-34 project. Receives: Behavioral: DBT Online Program |
| Email + DBT program & Coach | Experimental | Caring Email + DBT online program \& Coach: in addition to the DBT online program, will include personalized outreach and support for use of the program. An intervention "coach" will deliver this support exclusively via secure email messaging. The intervention coach will not provide psychotherapy, but instead provide reinforcement and contingency management surrounding completion of the three lessons. This intervention will utilize significantly greater ongoing clinical resources for its maintenance and offer greater clinical intensity for patients. Receives: Behavioral: DBT Online Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benchmark Acceptatiblity Rate
For each intervention, we define one or more specific acceptability measures. These measures will be assessed using data from the electronic medical record and/or the intervention website. For each measure, we define a benchmark acceptability rate that we believe is necessary to proceed to further evaluation in a full-scale effectiveness trial. As discussed below, the proposed sample size will allow us to estimate these acceptability rates with confidence limits of approximately +/-9%. Consequently, we will establish "observed" benchmark rates that account for this level of precision. We do not propose to compare acceptability rates across intervention groups. Our objective is not comparison but description: to assess whether the observed acceptability rate for each intervention exceeds our threshold for proceeding to a full-scale evaluation.
Measured: One Year
Secondary outcomes (1)
Number of Adverse Events
Electronic medical records will be used to ascertain all suicide attempts and all psychiatric hospitalizations in each of the three intervention groups. Chi-square statistic will be used to determine whether any observed difference in rates of adverse outcomes exceeds that expected by chance. In addition, each of these events will be reviewed by study investigators (Whiteside and Simon) to assess possible relationship to the intervention program.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
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 SuicideStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924936
- Sponsor's protocol ID
- 1R34MH097836-01
- Other IDs
- 1R34MH097836-01
- Acronym
- NMN_SSIP
- Status last verified
- Feb 2024
- First submitted
- 17 Jul 2013
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Whiteside U, Richards J, Simon GE. Brief Interventions via Electronic Health Record Messaging for Population-Based Suicide Prevention: Mixed Methods Pilot Study. JMIR Form Res. 2021 Apr 12;5(4):e21127. doi: 10.2196/21127.
PubMed 33843599
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Online Interventions for Population-based Suicide
- ClinicalTrials.gov ID
- NCT01924936
- Acronym / sponsor ID
- NMN_SSIP / 1R34MH097836-01
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Aug 2013 (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.
In the United States in 2010, 38,000 people died from suicide and it is our nation's 10 leading cause of death. Suicide prevention is a national priority and yet secondary prevention programs targeting those most at risk are lacking. The purpose of the current research is to develop and pilot test three promising suicide prevention programs that, if found acceptable to high-risk individuals, could be further evaluated and eventually offered broadly and affordably to the public.
Detailed description
Reducing the risk of suicide attempt and suicide is a public health priority. There has been no substantial decrease in suicide for the past two decades. Prevention efforts to date have focused on primary (e.g. public service announcements) and tertiary (e.g. interventions following suicide attempt) methods. Secondary or indicated prevention has been relatively unexplored. Secondary prevention requires both accurate screening methods and effective interventions. These essential elements are now available. Our recent research demonstrates that responses to the suicidal ideation item of the PHQ depression scale are a powerful predictor of subsequent suicide attempt and death. Availability of the PHQ in electronic medical records creates an opportunity for accurate population-level screening. Dialectical behavior therapy (DBT) has strong evidence of tertiary efficacy for preventing suicide attempts in clinical populations. Brief outreach tertiary interventions such as caring messages have some evidence for preventing suicide attempts. These clinical or tertiary prevention interventions provide the best available evidence for use in building secondary prevention programs. Resulting programs could then be linked to population-level screening data in electronic medical records. The first goal of the research plan is to adapt DBT and caring messages to fit delivery models suitable for the large numbers of at-risk patients identifiable in healthcare settings. The second goal is to evaluate the feasibility, acceptability, and safety of these alternative online suicide and self-injury secondary prevention programs. Online delivery models are suitable because they are scalable and can be provided securely, cheaply, and utilizing existing systems in healthcare. Three brief online interventions will be evaluated: caring email (CE); CE + DBT online program; and CE + DBT online program + coach. Each intervention will supplement usual care among high- risk patients identified via PHQ depression scales collected at outpatient primary care and mental health visits. Intervention content will be drawn from the principles of DBT and caring messages. The study design will be additive in order to examine alternative intervention models that vary widely in resources required for large- scale delivery. However, these interventions will require vastly fewer resources than in-person or telephone interventions. The project will involve intervention feasibility (pretesting, N=60) and acceptability and safety testing (pilot, N=400). Acceptability wll be assessed by patient intervention engagement levels (requiring the large pilot sample) and qualitative/formative intervention feedback from patients. Safety will be assessed via rates of psychiatric hospitalizations and self-injury diagnoses in the medical record in the intervention conditions compared to those receiving just continued usual care. Results of the pilot study will inform the design of a full-scale effectiveness trial examining the impact of one or more of these interventions on risk of suicide attempt and/or suicide death.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo comparator | Behavioral: DBT Online ProgramCaring email (based on the caring letters literature) sent via secure email messaging. Of the interventions, it is by far the most minimal in clinical intensity and human resources needs for delivery. | |
| DBT program | Experimental | Behavioral: DBT Online ProgramDBT online program involving three DBT skills taught across three lessons. The DBT online program will be based on a brief DBT skills intervention previously developed and pilot tested by Dr. Whiteside. This DBT online program will provide far greater clinical intensity than Intervention 1 and will be delivered with a widely-used modular software platform suitable for an R-34 project. |
| Email + DBT program & Coach | Experimental | Behavioral: DBT Online ProgramCaring Email + DBT online program \& Coach: in addition to the DBT online program, will include personalized outreach and support for use of the program. An intervention "coach" will deliver this support exclusively via secure email messaging. The intervention coach will not provide psychotherapy, but instead provide reinforcement and contingency management surrounding completion of the three lessons. This intervention will utilize significantly greater ongoing clinical resources for its maintenance and offer greater clinical intensity for patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Group Health members who are ID verified for secure email messaging
- Age 18 or older
- Results of PHQ assessment completed with a medical provider (Group Health primary care or mental health) as part of ongoing care indicate increased risk for self-injury (item 9, 2 or 3 response)
Key exclusion criteria (1 listed)
- 1. Patient has had a recent self-injury (past 60 days), as a more traditional clinical intervention would be more appropriate.
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 |
|---|---|---|
| DBT Online ProgramDBT online program involving three DBT skills taught across three lessons. The DBT online program will be based on a brief DBT skills intervention previously developed and pilot tested by Dr. Whiteside. This DBT online program will provide far greater clinical intensity than Intervention 1 and will be delivered with a widely-used modular software platform suitable for an R-34 project. | Behavioural | DBT program, Email, Email + DBT program & Coach |
Primary outcome
Benchmark Acceptatiblity Rate
Time frame: One Year
For each intervention, we define one or more specific acceptability measures. These measures will be assessed using data from the electronic medical record and/or the intervention website. For each measure, we define a benchmark acceptability rate that we believe is necessary to proceed to further evaluation in a full-scale effectiveness trial. As discussed below, the proposed sample size will allow us to estimate these acceptability rates with confidence limits of approximately +/-9%. Consequently, we will establish "observed" benchmark rates that account for this level of precision. We do not propose to compare acceptability rates across intervention groups. Our objective is not comparison but description: to assess whether the observed acceptability rate for each intervention exceeds our threshold for proceeding to a full-scale evaluation.
1 secondary outcome
Number of Adverse Events
Time frame: One Year
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 12 Feb 2024.
- Results publication: PubMed 33843599Whiteside U, Richards J, Simon GE. Brief Interventions via Electronic Health Record Messaging for Population-Based Suicide Prevention: Mixed Methods Pilot Study. JMIR Form Res. 2021 Apr 12;5(4):e21127. doi: 10.2196/21127.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT Online Program in people with Suicide and Suicide, Attempted, run by Kaiser Permanente at 1 site 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 3 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 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Benchmark Acceptatiblity Rate (time frame: One Year). 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 NCT01924936, 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 12 Feb 2024.