Feasibility and Acceptability Trial of a Short Term Mentalization Based Treatment for Adolescents With Depression

NCT06252090 | Recruiting

• 1 other identifier: CEC 262-22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility pilot trial that aims to evaluate the acceptability and feasibility of mentalization-based treatment for adolescents (MBT-A) adapted for early adolescents diagnosed with depression.

Conditions

Depression

Keywords

Depression; Adolescent; Mentalization; Family; Psychotherapy

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Number of subjects who agree to participate in the study compared to the number of subjects who are invited.

  After 3 months (at the end of therapy)

• Data attrition rate

  Number of subjects who complete the study with respect to subjects who are originally enrolled.

  After 3 months (at the end of therapy)

• Follow-up rate

  Number of subjects completing treatment and completing follow-up evaluations

  After 6 months (3 months after the end of therapy)

• Adherence rate

  Percentage of subjects completing all protocol assessments (including attendance at all 12 sessions).

  After 3 months (at the end of therapy)

• Overall satisfaction with the intervention

  Credibility/Expectancy Questionnaire (CEQ). Values range between 0 and 10 points. Each of the 8 items are analyzed separately. Higher scores indicate a better outcome, with the exception of item 6, which is reversed.

  Change from baseline in CEQ at 3 months (at the end of therapy)

Secondary Outcomes (6)

• Depressive symptomatology (adolescents)

  Change from baseline in the RCADS-30 depression subscale scores at 3 months (end of therapy) and at 5 months (follow-up)]

• Depressive symptomatology (responsible adult)

  Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).

• Anxious symptomatology (adolescent)

  Change from baseline in Generalized anxiety subscale of the Revised Child Anxiety and Depression Scale-30 (RCADS-30) for adolescents scores at 3 months (end of therapy) and 5 months (follow up).

• Anxious symptomatology (responsible adult)

  Change from baseline in Anxiety subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21) scores at 3 months (end of therapy) and 5 months (follow up).

• Externalizing and internalizing symptomatology (adolescent)

  Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up)

Other Outcomes (5)

• Therapeutic alliance

  Change in VTAS-SF scores through study completion, an average of 3 months

• Adherence to the therapeutic model

  Change in MBT-ACS scores through study completion, an average of 3 months

• Quality of patients' mentalization

  Change in OMP-A scores through study completion, an average of 3 months

Study Arms (1)

MBT-A

EXPERIMENTAL

Short term Mentalization-based treatment for adolescents (psychotherapy).

Other: Short term mentalization-based treatment for adolescents (MBT-A)

Interventions

Short term mentalization-based treatment for adolescents (MBT-A) OTHER

The general framework of intervention corresponds to the Mentalization-Based Treatment model for adolescents (MBT-A). In this study, the model was adapted to a brief, time-limited format (12 sessions) aimed at both the adolescent and their family. The model retains the main characteristics of Mentalization-Based Therapy, such as the therapist's basic attitude toward actively promoting patients' mentalization, uncertainty of mental states, focus on the here and now, and the use of affect as a mechanism for change.

MBT-A

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Mild to moderate major depressive disorder (DSM-5-TR and psychiatric interview).
• Written informed consent.
• Presence of at least one legally responsible adult consenting to participate in the therapeutic process.

You may not qualify if:

• Diagnoses of autism spectrum disorders
• Psychosis
• Bipolar affective disorder
• Active suicidal ideation
• Substance use disorder.
• Pregnancy

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• University Diego Portales: collaborator

Study Sites (1)

Jean & Marrie Thierry family public health center

Valparaíso, Chile

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Javier Moran, PhD

CONTACT

+56322507386; javier.moran@uv.cl

Javiera Duarte, PhD

CONTACT

+56226768631; javiera.duarte@mail.udp.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: February 9, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)