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

February 6, 2024 updated by: Javier Morán Kneer, Universidad de Valparaiso

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBT-A
Short term Mentalization-based treatment for adolescents (psychotherapy).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: After 3 months (at the end of therapy)
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
Time Frame: After 3 months (at the end of therapy)
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
Time Frame: After 6 months (3 months after the end of therapy)
Number of subjects completing treatment and completing follow-up evaluations
After 6 months (3 months after the end of therapy)
Adherence rate
Time Frame: After 3 months (at the end of therapy)
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
Time Frame: Change from baseline in CEQ at 3 months (at the end of therapy)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptomatology (adolescents)
Time Frame: Change from baseline in the RCADS-30 depression subscale scores at 3 months (end of therapy) and at 5 months (follow-up)]
Depression subscale of the Revised Child Anxiety and Depression Scale-30 (RCADS-30) for adolescents. Values range between 0 and 15 points. Lower scores indicate a better outcome.
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)
Time Frame: Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).
Patient Health Questionnaire-9 (PHQ-9). Values range between 0 and 27 points. Lower scores indicate a better outcome.
Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).
Anxious symptomatology (adolescent)
Time Frame: 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).
Generalized anxiety subscale of the Revised Child Anxiety and Depression Scale-30 (RCADS-30) for adolescents. Values range between 0 and 15 points. Lower scores indicate a better outcome.
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)
Time Frame: 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).
Anxiety subscale of the Depression, Anxiety and Stress Scale-21 (DASS-21). Values range between 0 and 21 points. Lower scores indicate a better outcome.
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)
Time Frame: Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up)
Strengths and Difficulties Questionnaire - Short Form (SDQ-SF). Values range between 0 and 40 points. Lower scores indicate a better outcome.
Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up)
Family cohesion
Time Frame: Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up)
Family Cohesion (FACES III). Values range between 0 and 50 points. Values between 41 to 45 (cohesion) and 25 to 28 (adaptability) indicate a better outcome.
Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic alliance
Time Frame: Change in VTAS-SF scores through study completion, an average of 3 months
Vanderbilt Therapeutic Alliance Scale - Short Form (VTAS-SF). Values range between 0 and 5 points. Each of the 5 items are analyzed separately. Higher scores indicate a better outcome, with the exception of item 3, which is reversed.
Change in VTAS-SF scores through study completion, an average of 3 months
Adherence to the therapeutic model
Time Frame: Change in MBT-ACS scores through study completion, an average of 3 months
Mentalization based treatment adherence and competence scale (MBT-ACS). Values range between 0 and 7 points. Higher scores indicate a better outcome.
Change in MBT-ACS scores through study completion, an average of 3 months
Quality of patients' mentalization
Time Frame: Change in OMP-A scores through study completion, an average of 3 months
Observational System for mentalization adolescent psychotherapy (OMP-A). Values range between 0 and 5 points. Higher scores indicate a better outcome.
Change in OMP-A scores through study completion, an average of 3 months
Psychological well-being (responsible adult)
Time Frame: Change in CORE-OM through study completion, an average of 3 months
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM). Values range between 0 and 136 points. Lower scores indicate a better outcome.
Change in CORE-OM through study completion, an average of 3 months
Psychological well-being (adolescent)
Time Frame: Change in YP-CORE through study completion, an average of 3 months
Young Person's Clinical Outcomes in Routine Evaluation (YP-CORE). Values range between 0 and 40 points. Lower scores indicate a better outcome.
Change in YP-CORE through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Collaborators

University Diego Portales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Estimated)

February 9, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC 262-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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