Dialectical Behavioral Therapy in Adolescents With Suicidal Behaviors

NCT ID: NCT02406625

Last Updated: 2017-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-02-28

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.

Conditions

Suicidal Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diaclectical Behavioral Therapy

15 adolescents with history of suicidal behaviors receiving Dialectical Behavioral Therapy.

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Support Therapy

15 adolescents with history of suicidal behaviors receiving Support Therapy.

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Controls

A group of 15 healthy controls that are not receiving any kind of therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral Therapy

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Santamarina Pérez, Pilar

UNKNOWN

Sponsor Role: collaborator

Romero Cela, María Soledad

UNKNOWN

Sponsor Role: collaborator

Méndez Blanco, Iria

UNKNOWN

Sponsor Role: collaborator

Font, Elena

UNKNOWN

Sponsor Role: collaborator

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Marisol Picado Rossi

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clínic

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 33677832 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31944371 (View on PubMed)

Other Identifiers

DBT001

Identifier Type: -

Identifier Source: org_study_id