Clinical trial NCT02406625: Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors
Official title: Clinical and Neural Changes Associated With Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Behaviors
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Santamarina Pérez, Pilar
name: Romero Cela, María Soledad
name: Méndez Blanco, Iria
name: Font, Elena
First posted: 2015-04-02
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical changes after 16 sessions of Dialectical Behavioral Therapy.
timeFrame: 4 months
measure: Neural changes after 16 sessions of Dialectical Behavioral Therapy.
timeFrame: 4 months
measure: Neuropsychological changes after 16 sessions of Dialectical Behavioral Therapy.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
citation: Santamarina-Perez P, Mendez I, Singh MK, Berk M, Picado M, Font E, Moreno E, Martinez E, Morer A, Borras R, Cosi A, Romero S. Adapted Dialectical Behavior Therapy for Adolescents with a High Risk of Suicide in a Community Clinic: A Pragmatic Randomized Controlled Trial. Suicide Life Threat Behav. 2020 Jun;50(3):652-667. doi: 10.1111/sltb.12612. Epub 2020 Jan 16.