Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers
2 other identifiers
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedMay 4, 2018
May 1, 2018
1.3 years
October 10, 2016
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
EXPERIMENTALThe 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.
Waitlist
NO INTERVENTIONA 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
Eligibility Criteria
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
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.
PMID: 37012190DERIVEDWilks 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.
PMID: 29070480DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chelsey R Wilks, M.S.
University of Washington
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