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Completed

NCT Number: NCT02406625

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.

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Key information

Conditions

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral therapy

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DBT

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 2, 2015
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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