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Suicidal IdeationNCT02932241

Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers

A study testing Computerized Dialectical Behavior Therapy Skills Training in people with Suicidal Ideation and Alcohol Drinking, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicidal Ideation, Alcohol Drinking
What is being tested?
Computerized Dialectical Behavior Therapy Skills Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Jun 2016to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

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.

Read the 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.

Being tested
Computerized Dialectical Behavior Therapy Skills Training
Medical subject headings
Suicidal Ideation, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized Dialectical Behavior Therapy Skills TrainingBehavioural

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

Study groups in NCT02932241
Study groupRoleWhat they receive
Computerized DBT skills trainingExperimentalThe 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.
Receives: Behavioral: Computerized Dialectical Behavior Therapy Skills Training
WaitlistNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol Use

    Time line follow back to assess quantity and frequency

    Measured: 16 weeks

Secondary outcomes (2)
  1. Acceptability, as measured by the Client Satisfaction Inventory (CSI).

    The degree to which this population experiences satisfaction with the intervention.

    Measured: 8 weeks

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

    Severity of suicidal ideation.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionSep 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932241
Sponsor's protocol ID
STUDY00002445
Other IDs
F31AA024658-01
Status last verified
May 2018
First submitted
10 Oct 2016
Last updated
4 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: The investigators have yet to determine whether or not to share data; if so, all data would be de-identified.

Publications

  • 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.

    PubMed 37012190
  • 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.

    PubMed 29070480

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Dialectical Behavior Therapy Skills Training in people with Suicidal Ideation and Alcohol Drinking, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alcohol Use (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932241, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.

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