NCT01924936

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2.4 years

First QC Date

July 17, 2013

Last Update Submit

February 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    One Year

Secondary Outcomes (1)

  • Number of Adverse Events

    One Year

Study Arms (3)

Email

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.

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.

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.

Behavioral: DBT Online Program

Interventions

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 programEmailEmail + DBT program & Coach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98102, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

SuicideSuicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

August 19, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations