Suicidal Ideation Clinical Trial
Official title:
Computerized DBT Skills Training for Suicidal and Heavy Episodic Drinkers
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05334381 -
Navigating Mental Health Treatment for Black Youth
|
N/A | |
Recruiting |
NCT04653337 -
Neuroimaging Guided and Robot-assisted rTMS for Suicidal Ideation of Depression
|
Phase 2 | |
Terminated |
NCT04254809 -
Evaluation of a Computerized Intervention for Learning to Re-Evaluate Suicidal Thoughts
|
N/A | |
Recruiting |
NCT05848089 -
Real-time Intervention for Suicide Risk Reduction
|
N/A | |
Recruiting |
NCT06322199 -
Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3
|
||
Completed |
NCT05280756 -
Home-based tDCS for Prevention of Suicidal Ideation
|
N/A | |
Not yet recruiting |
NCT06454136 -
Pilot Trial of Mobile Technology for Adolescent Suicidality
|
N/A | |
Completed |
NCT01944293 -
Ketamine for Suicidality in Bipolar Depression
|
Phase 1/Phase 2 | |
Completed |
NCT02021344 -
Mental Health First Aid for College Students
|
N/A | |
Not yet recruiting |
NCT04686162 -
Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal Behavior: Study of Acceptability and Preliminary Results of Efficacy
|
N/A | |
Recruiting |
NCT05377177 -
Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
|
N/A | |
Completed |
NCT05580757 -
Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
|
||
Recruiting |
NCT05925322 -
Brain Changes During Social Reward Psychotherapy for Mid- and Late-Life Suicidality
|
N/A | |
Not yet recruiting |
NCT05427734 -
Treating Drivers of Suicide Using Jaspr Health
|
N/A | |
Recruiting |
NCT04112368 -
Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach
|
Phase 4 | |
Completed |
NCT04026308 -
Written vs Electronic Safety Planning Study
|
N/A | |
Recruiting |
NCT05537376 -
A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness
|
N/A | |
Not yet recruiting |
NCT06311591 -
Efficacy, Effectiveness, and Implementation of Jaspr Health in Emergency Department- Part B
|
N/A | |
Recruiting |
NCT05894980 -
How to Reduce Suicidal Thoughts and Impulsivity in Depression
|
N/A | |
Not yet recruiting |
NCT05860257 -
Transforming Adolescent Mental Health Through Accessible, Scalable, Technology-supported Small-group Instruction
|
N/A |