NCT07039058

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

June 18, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

Dialectical Behavior TherapySkills TrainingSuicide ideationRandomized

Outcome Measures

Primary Outcomes (5)

  • Change from Baseline in the Suicidality at 1 Month as Assessed by Suicide Probability Scale

    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

    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

    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

    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

    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 Outcomes (1)

  • Change from Baseline in the Depression, Anxiety, and Stress at 1 Month as Assessed by Depression Anxiety Stress Scale-21 (DASS-21)

    From enrollment to the end of intervention at 1 week and follow-up at 1 month

Study Arms (2)

Brief Dialectical Behavior Therapy-Skills Training

EXPERIMENTAL
Behavioral: Brief Dialectical Behavior Therapy-Skills Training

Relaxation control group

ACTIVE COMPARATOR
Behavioral: Relaxation

Interventions

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.

Brief Dialectical Behavior Therapy-Skills Training
RelaxationBEHAVIORAL

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.

Relaxation control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • not speaking Turkish
  • loss or trauma in the last 1 year
  • pharmacological treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University, Suicide and Stress Research Laboratory

Aydin, Aydın, 09500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Psychology Master's Student

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

October 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations