Now Matters Now: An Online Suicide Prevention Program

NCT ID: NCT01924936

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Suicide Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Email

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.

Group Type PLACEBO_COMPARATOR

DBT Online Program

Intervention Type BEHAVIORAL

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.

DBT program

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.

Group Type EXPERIMENTAL

DBT Online Program

Intervention Type BEHAVIORAL

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.

Email + DBT program & Coach

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.

Group Type EXPERIMENTAL

DBT Online Program

Intervention Type BEHAVIORAL

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.

Interventions

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DBT Online Program

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Group Health members who are ID verified for secure email messaging
2. Age 18 or older
3. 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)

Exclusion Criteria

1\. Patient has had a recent self-injury (past 60 days), as a more traditional clinical intervention would be more appropriate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33843599 (View on PubMed)

Related Links

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Other Identifiers

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1R34MH097836-01

Identifier Type: NIH

Identifier Source: secondary_id

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1R34MH097836-01

Identifier Type: NIH

Identifier Source: org_study_id

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