Clinical trial NCT02932241: Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers
Official title: Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Alcohol Drinking
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: It is well established that clinical research should focus on streamlining treatments in ways that maximizes their potency and ease of implementation. The application of technology has been increasingly utilized as an effective and acceptable way to rapidly disseminate evidence-base treatment. However, these methods are used infrequently for individuals deemed too high risk for computerized psychotherapy. This atheoretical approach to participant exclusion broadens the treatment gap among those in dire need of treatment. Along these lines, the primary goal of this project is to establish a proof of concept for developing and evaluating an efficacious and acceptable intervention for heavy episodic drinkers who are suicidal.

This scope has been selected to increase feasibility for this pilot trial and to allow comparison with a wait-list control condition, providing important groundwork for a subsequent randomized control trial. The proposed research will take place in one phase and will fall within Stage 1a and 1b of the updated Stage Model for Behavioral Therapy Research. This project will consist of a randomized controlled pilot trial, an initial "strong test" of efficacy of cDBT for the treatment of HED and suicidal behaviors, using a between groups design. This method of intervention delivery (e.g. computerization) will allow for ease of transition to subsequent stages that fit the updated scope of Behavioral Therapy Research which highlight the need for dissemination and implementation. The overall aim of this project is not to demonstrate that cDBT works better than other interventions in improving outcomes, but rather to provide preliminary evidence that the intervention is feasible and efficacious in producing change when delivered through an easily disseminated and acceptable method.

The primary goal of computerized DBT Skills Training will be to eliminate HED and suicidal behavior that function to regulate emotions while simultaneously increasing behavioral control through the use of functional, skillful behavior. cDBT-ER is an existing 8-week computerized skills intervention that targets difficulties in emotion regulation and includes numerous skills that explicitly target modifying emotional states. DBT skills translate well into computerized interventions, as they are based on learning models in which patients are taught reproducible skills to be used in their environment. The proposed intervention will require adding the DBT addiction skills to target heavy drinking as well as including a computerized version of a risk assessment protocol to assess suicidal urges electronically. The DBT addiction skills draw largely from relapse prevention and include DBT adaptations of Harm Reduction (via "Dialectical Abstinence") and Urge Surfing (via "Burning Bridges). The addiction skills have been implemented in numerous DBT studies that explicitly target addictive behavior with positive outcomes in reducing substance and alcohol use. Thus, cDBT would teach clients ways to reduce and eliminate alcohol consumption, along with skillful behaviors to effectively manage negative emotions.

Eligibility criteria: Inclusion Criteria:

1. Current suicidal ideation in last 4 weeks
2. 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)
3. High emotion dysregulation defined as being one standard deviation above the mean on the DERS
4. Age \>=18 years old
5. English speaking
6. Medication usage stabilized
7. Consents to study
8. Has Internet \& phone access

Exclusion Criteria:

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

Primary outcomes:
measure: Alcohol Use
timeFrame: 16 weeks
Secondary outcomes:
measure: Acceptability, as measured by the Client Satisfaction Inventory (CSI).
timeFrame: 8 weeks
measure: Suicidal ideation, as measured by the Beck's Scale for Suicidal Ideation (BSSI).
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Chelsey R Wilks, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.