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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252090
• Other study ID #: CEC 262-22
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: February 2024
• Source: Universidad de Valparaiso
• Contact: Javier Moran, PhD
• Phone: +56322507386
• Email: javier.moran[@]uv.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Chile	Jean & Marrie Thierry family public health center	Valparaíso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	University Diego Portales

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Therapeutic alliance	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
Other	Adherence to the therapeutic model	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
Other	Quality of patients' mentalization	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
Other	Psychological well-being (responsible adult)	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
Other	Psychological well-being (adolescent)	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
Primary	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)
Primary	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)
Primary	Follow-up rate	Number of subjects completing treatment and completing follow-up evaluations	After 6 months (3 months after the end of therapy)
Primary	Adherence rate	Percentage of subjects completing all protocol assessments (including attendance at all 12 sessions).	After 3 months (at the end of therapy)
Primary	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	Depressive symptomatology (adolescents)	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)]
Secondary	Depressive symptomatology (responsible adult)	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).
Secondary	Anxious symptomatology (adolescent)	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).
Secondary	Anxious symptomatology (responsible adult)	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).
Secondary	Externalizing and internalizing symptomatology (adolescent)	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)
Secondary	Family cohesion	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)