Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors (DBT)

February 16, 2017 updated by: Marisol Picado Rossi, Fundacion Clinic per a la Recerca Biomédica

Clinical and Neural Changes Associated With Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors

Suicidal behaviors among adolescents represents a public health problem due to its high prevalence and its low predictability. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that might favor the emotional regulation involved in suicidal behaviors. Dialectical Behavioral Therapy has proved to be effective regarding this problem.

For this reason, the investigators aimed to study the clinical, neuropsychological and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Suicidal behaviors represent a public health problem due to its high prevalence and its low predictability. At a neurological level, higher vulnerability for suicidal behavior has been related to a frontostriatal-cingulum tract dysfunction as well as attention, memory and executive deficits. It is also known that brain development continues during adolescence, therefore, a therapeutic intervention during this period might propitiate neural changes that could favor the emotional regulation involved in suicidal behaviors. Specifically, Dialectical Behavioral Therapy has proved to be effective regarding this problem.

The investigators hypothesis is that DBT (Dialectical Behavioral Therapy) will improve clinical symptoms associated with suicidal behaviors, as well as the neural interconnections, which will result not only in structural and functional connectivity changes, but also in a better cognitive functioning. The investigators aimed to investigate the clinical, neuropsychological, and neural effects of Dialectical Behavioral Therapy in adolescents with suicidal behaviors.

The investigators method is a randomized, controlled study that includes 30 patients with suicidal behaviors and 15 healthy controls between the ages of 12 and 18 years. Patients were assigned to one of two groups (randomized): DBT and Regular Support Therapy. Clinical and neuropsychological evaluations were performed before and after the treatment for both patient groups. Additionally, Structural MRI data sets, diffusion-tensor imaging (DTI) and Functional Connectivity (Resting State fmri) were acquired for all patients and controls at baseline and after treatment. Initial characteristics will be compared between the three groups, and the investigators will also compared clinical, neuropsychological and imaging measures before and after the treatment.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 12 and 18 years,
  • Intellectual level over 70 (IQ>70)

  • For the experimental groups:

    • Patients with suicidal behavior:

      • Real attempt,
      • Interrupted attempt,
      • Aborted attempt or behaviors, or
      • Preparation actions (based on the Columbia Suicide Severity Rating Scale -C-SSRS criteria) present during the last 12 months and that persist in the actual moment.

Exclusion Criteria:

  • Presence of Acute Psychosis,
  • Eating Disorder with an BMI < 18.5;
  • Substance abuse in the current moment or during the last 6 months;
  • Any neurological condition that curses with cognitive alterations; and
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaclectical Behavioral Therapy
15 adolescents with history of suicidal behaviors receiving Dialectical Behavioral Therapy.
Behavioral: Behavioral Therapy
16 therapeutic group sessions are delivered to both parents and adolescents; according to the assigned group for each family.
Experimental: Support Therapy
15 adolescents with history of suicidal behaviors receiving Support Therapy.
Behavioral: Behavioral Therapy
16 therapeutic group sessions are delivered to both parents and adolescents; according to the assigned group for each family.
No Intervention: Controls
A group of 15 healthy controls that are not receiving any kind of therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical changes after 16 sessions of Dialectical Behavioral Therapy.
Time Frame: 4 months
Clinical evaluations will be performed before and after the treatment in order to determine clinical improvement in relation to the applied therapy.
4 months
Neural changes after 16 sessions of Dialectical Behavioral Therapy.
Time Frame: 4 months
Magnetic Resonance Imaging and functional Magnetic Resonance Imaging data sets will be acquired at baseline and then after the treatment, in order to determine anatomical or functional brain connectivity changes in relation to the applied therapy.
4 months
Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy.
Time Frame: 4 months
Neuropsychological evaluations will be administrated before and after the treatment in order to determine changes in memory, attention or executive functioning in relation to the applied therapy.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Collaborators

Santamarina Pérez, Pilar
Romero Cela, María Soledad
Méndez Blanco, Iria
Font, Elena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DBT001

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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