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Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers

Primary Purpose

Suicidal Ideation, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Dialectical Behavior Therapy Skills Training
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computerized DBT skills training

Waitlist

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Alcohol Use
Time line follow back to assess quantity and frequency

Secondary Outcome Measures

Acceptability, as measured by the Client Satisfaction Inventory (CSI).
The degree to which this population experiences satisfaction with the intervention.
Suicidal ideation, as measured by the Beck's Scale for Suicidal Ideation (BSSI).
Severity of suicidal ideation.

Full Information

First Posted
October 10, 2016
Last Updated
May 2, 2018
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02932241
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Alcohol Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized DBT skills training
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Dialectical Behavior Therapy Skills Training
Intervention Description
8, 50 minute skill training sessions made available to participants each week
Primary Outcome Measure Information:
Title
Alcohol Use
Description
Time line follow back to assess quantity and frequency
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Acceptability, as measured by the Client Satisfaction Inventory (CSI).
Description
The degree to which this population experiences satisfaction with the intervention.
Time Frame
8 weeks
Title
Suicidal ideation, as measured by the Beck's Scale for Suicidal Ideation (BSSI).
Description
Severity of suicidal ideation.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Bipolar I, Schizophrenia, Schizophreniform, Schizoaffective Disorders, Psychosis, Lives outside of referral network (U.S). Court ordered for treatment Unable to read and write
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chelsey R Wilks, M.S.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators have yet to determine whether or not to share data; if so, all data would be de-identified.
Citations:
PubMed Identifier
29070480
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.
Results Reference
derived

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Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers

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