NCT06252090

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

Feasibility and Acceptability of Mentalization-based Treatment for Early Adolescents With Depression: A Short Term Psychotherapy Approach for Patients and Their Families

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Universidad de Valparaiso · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background. Adolescent depression is a highly prevalent public health concern, entailing substantial developmental impairments, a risk of chronicity, and severe outcomes, including suicide. Recent years have seen an escalation in depressive symptoms among adolescents, exacerbated by the COVID-19 pandemic. Currently, Chile lacks specific evidence-based clinical guidelines for family interventions in adolescent depression. Nonetheless, the executive summary of the Clinical Practice Guidelines for the Management of Adolescent Depression recognizes the need for such interventions. The 2022-2025 agenda for children and adolescents incorporates these interventions as part of the recommendations, addressing challenges identified by the System of Guarantees for the Comprehensive Protection of the Rights of Children and Adolescents and aligning with the International Convention on the Rights of Children and Adolescents' standards. The strategy proposed herein-a brief, mentalization-based treatment intervention for adolescents-aligns with two pivotal considerations for adolescent mental health care: accommodating the neurodevelopmental changes and vulnerabilities of this demographic, and leveraging the preventative potential of family interventions at a systemic level. Aims. The study is a feasibility pilot trial that aims to evaluate the acceptability and feasibility of a short term mentalization based treatment for adolescents (MBT-A). 15 families of adolescents with a diagnosis of mild and moderate unipolar depression between 10 and 14 years old who consult at a primary health care center in Valparaíso will be recruited. Methods. The design is based on the principles of the Consolidated Standards of Reporting Trials - Extension to Randomized Pilot and Feasibility Trials (CONSORT). Acceptability and feasibility outcomes will be assessed by means of questionnaires and interviews with both consultants and interveners, considering the training, clinical supervision, and intervention processes. Feasibility (recruitment, data attrition, and follow-up rates) and acceptability (adherence rate and CEQ) of the intervention, along with depressive (PHQ-9/RCADS-30), anxious (DASS-21), externalizing/internalizing (SDQ-SF) symptomatology, and Family Cohesion (FACES III) as secondary outcomes, will be considered. Therapeutic alliance (VTAS-SF), adherence to the therapeutic model (MBT-ACS), quality of patients' mentalization (OMP-A), and psychological well-being (CORE-OM/YP-CORE) will be assessed as well. The results of the analysis of interviews, as well as the calculation of the effect size of the intervention for the various outcomes, are considered as parameters and guidelines for a future RCT.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	Short term mentalization-based treatment for adolescents (MBT-A)	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2024-02-09
• Last updated: 2024-02-09

Locations

1 site across 1 country: Chile