- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07039058
- Original Trial
Brief DBT Skills Training for Coping With Suicidal Ideation
Brief Dialectical Behavior Therapy-Skills Training for Coping With Suicidal Ideation: A Randomized Controlled Trial
The goal of this clinical trial is to learn if Brief Dialectical Behavior Therapy Skills Training (DBT-BST) can prevent suicidality in adults. The main questions it aims to answer are:
- Does DBT-BST provide coping strategies (e.g., emotion regulation) to participants with suicidal ideation?
- Does DBT-BST lower participants' suicide ideation?
Researchers will compare DBT-BST to relaxation to see if DBT-BST works to reduce suicidal ideation.
Participants will:
- Receive DBT-BST in a single 60-minute, in-person, individual session.
- Be asked to use these skills as self-help and for crisis prevention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Aydın
-
Aydin, Aydın, Turkey (Türkiye), 09500
- Aydın Adnan Menderes University, Suicide and Stress Research Laboratory
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being 18 years of age or older
- having suicidal ideation in the last 3 months
- not having received any psychological treatment in the last 1 month
- living in Aydın/Türkiye where the intervention will be implemented
- giving consent for participation
Exclusion Criteria:
- not speaking Turkish
- loss or trauma in the last 1 year
- pharmacological treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brief Dialectical Behavior Therapy-Skills Training
|
The intervention is administered in a single session, lasting approximately 60 minutes and conducted in person. It is important to note that there are no ongoing sessions. In the intervention, participants are provided with 5 basic skills of Dialectical Behavior Therapy: 1) mindfulness, 2) mindfulness of current emotions, 3) opposite-to-emotion action, 4) distraction, and 5) changing body chemistry. These strategies are grouped under 3 categories: 1) Mindfulness, 2) Emotion regulation (mindfulness of current emotions, opposite-to-emotion action), 3) Tolerating distress (distraction, changing body chemistry). These skills are not designed to treat or solve the crisis. The main aim is to provide effective coping mechanisms that can be implemented quickly before the crisis escelates, to help overcome the intense emotional pain and keep the person alive. |
|
Active Comparator: Relaxation control group
|
The control group will be subjected to a relaxation exercise, with the objective of managing participant expectations, researcher attention/interest, and time spent, as well as providing a coping strategy for stress.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Suicidality at 1 Month as Assessed by Suicide Probability Scale
Time Frame: From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
36 is equivalent to the lowest suicidality, and 144 indicates the highest suicidality.
|
From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
|
Change from Baseline in the Suicidal Cognitions at 1 Month as Assessed by Suicide Cognitions Scale
Time Frame: From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
18 is equivalent to the lowest suicidal cognitions, and 90 indicates the highest suicidal cognitions.
|
From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
|
Change from Baseline in the Hopelessness at 1 Month as Assessed by Beck Hopelessness Scale
Time Frame: From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
Zero is equivalent to the lowest hopelessness, and 20 indicates the highest hopelessness.
|
From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
|
Change from Baseline in the Emotion Regulation Skills at 1 Month as Assessed by Emotion Regulation Skills Questionnaire
Time Frame: From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
Zero is equivalent to the lowest emotion regulation skills, and 108 indicates the highest skills.
|
From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
|
Change from Baseline in the Difficulties in Emotion Regulation at 1 Month as Assessed by Difficulties in Emotion Regulation Scale-16
Time Frame: From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
16 is equivalent to the lowest difficulties, and 80 indicates the highest difficulties in emotion regulation.
|
From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in the Depression, Anxiety, and Stress at 1 Month as Assessed by Depression Anxiety Stress Scale-21 (DASS-21)
Time Frame: From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
Higher points are equivalent to higher symptoms as assessed by the related subscale of DASS-21.
Each subscale ranges from 0 to 28.
|
From enrollment to the end of intervention at 1 week and follow-up at 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BriefDBT-ST30/05/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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