NCT02932241

Brief Summary

Alcohol use is considered to be a significant risk factor among those who die by suicide, especially among those who drink to regulate their emotions. Unfortunately, there is a dearth of treatment outcome research for suicidal heavy drinkers. Further, treatments that target this population must be maximally effective, with promise for wide dissemination. The application of technology has been increasingly utilized as an efficacious and acceptable way to rapidly disseminate evidence-base treatment. However, these methods are used infrequently for individuals deemed too high risk for computerized treatment. Along these lines, the goal of this project is to begin a line of research focused on developing interventions to reduce heavy drinking and risk for suicide through the use of technology. Dialectical Behavior Therapy (DBT) skills training is an effective intervention for behaviors associated with emotion dysregulation including addictive and suicidal behaviors. Further, DBT skills use has been identified as the active ingredient for treatment effectiveness; thus, a skills training intervention delivered via the Internet has the capacity to be a potent and efficient method of treatment delivery. The goal of this research is to establish a proof of concept for developing and evaluating a potentially efficacious and acceptable intervention for heavy episodic drinkers who are suicidal. Specifically, this project proposes to conduct a randomized controlled pilot trial of a computerized DBT skills training intervention for suicidal individuals who engage in heavy episodic drinking (HED) to regulate emotions. The project's aims are to conduct a randomized controlled pilot trial of cDBT vs. a Wait-list control (WL). This pilot trial is not intended to demonstrate that cDBT works better than other interventions in improving clinical indices, but rather to determine whether further revisions of the cDBT intervention are needed and will inform the design of a subsequent full-scale randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

October 10, 2016

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Alcohol Use

    Time line follow back to assess quantity and frequency

    16 weeks

Secondary Outcomes (2)

  • Acceptability, as measured by the Client Satisfaction Inventory (CSI).

    8 weeks

  • Suicidal ideation, as measured by the Beck's Scale for Suicidal Ideation (BSSI).

    16 weeks

Study Arms (2)

Computerized DBT skills training

EXPERIMENTAL

The Computerized Dialectical Behavior Therapy Skills Training (cDBT) intervention includes 4 mindfulness, 6 emotion regulations, 2 distress tolerance, and 4 addiction skills. cDBT will retain the essence of DBT skills by being didactically focused, having a predetermined agenda driven by skills to be taught, emphasizing modeling through video vignettes, incorporating in session practice of skills whenever feasible, reviewing homework at beginning of sessions before teaching new skills, and assigning practice between sessions.

Behavioral: Computerized Dialectical Behavior Therapy Skills Training

Waitlist

NO INTERVENTION

A waitlist (WL) control condition was chosen considering the pilot nature of the study, feasibility, and the overall goal of assessing treatment's promise. Participants will be assessed for drinking and suicidal urges in the same manner as in the cDBT condition. After 8 weeks, subjects will be able to enroll in the intervention.

Interventions

8, 50 minute skill training sessions made available to participants each week

Computerized DBT skills training

Eligibility Criteria

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

You may qualify if:

  • Current suicidal ideation in last 4 weeks
  • Heavy episodic drinkers (reporting consumption of 4 drinks for women and 5 drinks for men over a 2 hour period at least twice in the past month)
  • High emotion dysregulation defined as being one standard deviation above the mean on the DERS
  • Age \>=18 years old
  • English speaking
  • Medication usage stabilized
  • Consents to study
  • Has Internet \& phone access

You may not qualify if:

  • Bipolar I, Schizophrenia, Schizophreniform, Schizoaffective Disorders, Psychosis,
  • Lives outside of referral network (U.S).
  • Court ordered for treatment
  • Unable to read and write

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • Yin Q, Wilks CR. Untangling the temporal association between daily urges to die by suicide and to use substances. Psychiatry Res. 2023 May;323:115178. doi: 10.1016/j.psychres.2023.115178. Epub 2023 Mar 22.

  • Wilks C, Yin Q, Ang SY, Matsumiya B, Lungu A, Linehan M. Internet-Delivered Dialectical Behavioral Therapy Skills Training for Suicidal and Heavy Episodic Drinkers: Protocol and Preliminary Results of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Oct 25;6(10):e207. doi: 10.2196/resprot.7767.

MeSH Terms

Conditions

Suicidal IdeationAlcohol Drinking

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorDrinking Behavior

Study Officials

  • Chelsey R Wilks, M.S.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 13, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations