DepressionNCT06252090
Feasibility and Acceptability Trial of a Short Term Mentalization Based Treatment for Adolescents With Depression
A study testing Short term mentalization-based treatment for adolescents (MBT-A) in people with Depression, run by Universidad de Valparaiso at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Depression
- What is being tested?
- Short term mentalization-based treatment for adolescents (MBT-A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChile
- Study dates
- 1 Sep 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Diagnoses of autism spectrum disorders
- Psychosis
- Bipolar affective disorder
- Active suicidal ideation
- Substance use disorder.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Jean & Marrie Thierry family public health center
Valparaíso
Pamela González, Bachelor of Psychology, +56322211555, psi.pamelagonzalez@gmail.com
Lucy Granda, +56322211555, psi.pamelagonzalez@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- Short term mentalization-based treatment for adolescents (MBT-A)
- Keywords
- Depression, Adolescent, Mentalization, Family, Psychotherapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MBT-A | Experimental | Short term Mentalization-based treatment for adolescents (psychotherapy). Receives: Other: Short term mentalization-based treatment for adolescents (MBT-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of subjects who agree to participate in the study compared to the number of subjects who are invited.
Measured: 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.
Measured: After 3 months (at the end of therapy)
Follow-up rate
Number of subjects completing treatment and completing follow-up evaluations
Measured: 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).
Measured: 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.
Measured: Change from baseline in CEQ at 3 months (at the end of therapy)
Secondary outcomes (6)
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.
Measured: 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)
Patient Health Questionnaire-9 (PHQ-9). Values range between 0 and 27 points. Lower scores indicate a better outcome.
Measured: Change from baseline in PHQ-9 scores at 3 months (end of therapy) and 5 months (follow up).
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.
Measured: 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)
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.
Measured: 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)
Strengths and Difficulties Questionnaire - Short Form (SDQ-SF). Values range between 0 and 40 points. Lower scores indicate a better outcome.
Measured: Change from baseline in the SDQ-SF scores at 3 months (end of therapy) and at 5 months (follow-up)
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.
Measured: Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- University Diego Portales
- Responsible party
- Principal investigator, Javier Morán Kneer, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252090
- Sponsor's protocol ID
- CEC 262-22
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Mentalization-based Treatment for Early Adolescents With Depression: A Short Term Psychotherapy Approach for Patients and Their Families
- ClinicalTrials.gov ID
- NCT06252090
- Acronym / sponsor ID
- CEC 262-22
- Conditions
- Depression
- Keywords
- Depression, Adolescent, Mentalization, Family, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- University Diego Portales
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBT-A | Experimental | Other: Short term mentalization-based treatment for adolescents (MBT-A)Short term Mentalization-based treatment for adolescents (psychotherapy). |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Diagnoses of autism spectrum disorders
- Psychosis
- Bipolar affective disorder
- Active suicidal ideation
- Substance use disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | MBT-A |
Primary outcome
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.
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.
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
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).
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.
6 secondary outcomes
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)]
Depressive symptomatology (responsible adult)
Time frame: 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).
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).
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)
Family cohesion
Time frame: Change from baseline in the FACES III scores at 3 months (end of therapy) and at 5 months (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short term mentalization-based treatment for adolescents (MBT-A) in people with Depression, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Moran, PhD (+56322507386, javier.moran@uv.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: After 3 months (at the end of therapy)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.