Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors

Suicidal Behaviors Clinical Trial

— DBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406625
• Other study ID #: DBT001
• Status: Completed
• Phase: N/A
• First received: March 19, 2015
• Last updated: February 16, 2017
• Start date: November 2014
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Behaviors

Intervention

Behavioral:
• Behavioral Therapy
16 therapeutic group sessions are delivered to both parents and adolescents; according to the assigned group for each family.

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica	Font, Elena, Méndez Blanco, Iria, Romero Cela, María Soledad, Santamarina Pérez, Pilar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical changes after 16 sessions of Dialectical Behavioral Therapy.	Clinical evaluations will be performed before and after the treatment in order to determine clinical improvement in relation to the applied therapy.	4 months
Primary	Neural changes after 16 sessions of Dialectical Behavioral Therapy.	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
Primary	Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy.	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