Anxiety DisordersNCT06833567
Mentalizing and Epistemic Trust in Patients With Anxiety and Depression.
A study testing Brief mentalization-based group psychotherapy and Acceptance and Commitment Therapy group intervention in people with Anxiety Disorders and Depression, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
This randomized clinical trial aims to evaluate the effects of mentalization-based group psychotherapy in patients diagnosed with anxiety and/or depression disorders. In total 100 users of mental health communitary services will be recruited for this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Brief mentalization-based group psychotherapy and Acceptance and Commitment Therapy group intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 28 Apr 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are 18 years or older.
- Participants have a diagnosis of ICD-10 F32, F33, F34, F41.1, F41.2, F43 or F43.2.
- Participants have minimal relational skills to participate in group therapy.
- Participants agree to be part of the study by giving signed written consent.
Who cannot join
- Participants have a diagnosis of ICD-10 F10-19, F20-29, F31, F42, F43.1, F60.
- Participants with cognitive deficits assessed during the initial interview or diagnosis of ICD-10 F70-79.
- Participants with planning or structured suicidal ideation.
- Participants with difficulties in relational skills evaluated during the initial interview.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigacion Biomedica de Malaga - IBIMA
Málaga, Malaga, 29009
Maria Traverso, +34 660512210, mariatraverso8@gmail.com
Maria Traverso Rodriguez
About this study
Official title: Brief Mentalization-based Group Psychotherapy for Anxiety and Depression Disorders and Spanish Cultural Adaptation and Validation of the Epistemic Trust Questionnaire (QET)
This randomized clinical trial aims to evaluate the effects of mentalization-based group psychotherapy in patients diagnosed with anxiety and/or depression disorders. In total 100 users of mental health communitary services will be recruited for this study. Participants will be randomized in two parallel groups: to receive usual acceptance and commitment therapy group intervention (control group) or to receive brief mentalization-based group psychotherapy (intervention group). Participants in the trial will be assessed at baseline and at 3 months.
Read the detailed description
QUALITY ASSURANCE PLAN. The researchers will review and report the process during the trial covering participant enrolment, consent and eligibility to protect participants, including reporting of harm and completeness, accuracy and timeliness of data collection.
STANDARD OPERATING PROCEDURES. Participants will be identified from community mental health services who meet all the study eligibility criteria (listed in section Eligibility). Participants will be recruited over a period of 20 months by mental health professionals (clinical psychology residents). Community sample for validation will be recruited by social media. Participants will not receive financial reimbursement for taking part in this trial.
DATA DICTIONARY. All variables collected in this study are listed and described in an electronic case report form, with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial:
Sociodemographical data. Anxiety symptoms: Generalized Anxiety Disorder 7-item scale (GAD-7) Depressive symptoms: Patient Health Questionnaire-9 (PHQ-9) Epistemic Trust: Questionnaire Epistemic Trust (QET) Epistemic Trust, Mistrust and Credulity: The Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ).
Reflective functioning: The Reflective Functioning Questionnaire (RFQ-8) Functional impact: The Work and Social Adjustment Scale (WSAS) Satisfaction with therapy: The Consumer Reports Effectiveness Score (CRES-4)
SAMPLE SIZE ASSESSMENT. The study has sensitivity to detect effect sizes that are considered clinically significant (Cohen's d =0.50) for a power of 0.8, an Alpha of 0.05 and an estimated sample of 100 participants. The calculation was performed with the GPower 3.1.9.2 program for a mean difference with a t-test for two independent groups.
For the validation of the QET, taking into account the subject-item ratio of at least 5: 1 (24 items), and considering the minimum number of recommended subjects to perform an Exploratory Factor Analysis, the minimum number of participants must be 150.Thus, estimating losses of 20%, the total number of participants estimated for the validation is n = 180 .
STATISTICS ANALYSIS PLAN. The analysis will be made following an intention-to-treat procedure. The change of means in the primary outcome variable between the two study groups will be analyzed with the Student's t-test for independent samples if the criteria for its application are met. If the criteria for its application are not met, nonparametric tests will be used. For continuous secondary variables, this test will also be used. A multivariate analysis of variance (ANCOVA) will also be considered to introduce any possible covariate that differs between the two comparison groups in the first evaluation. Potential confounding variables will include gender, age, previous level of depression and anxiety, and diagnosis. A 95% confidence level will be used for all comparisons. The R program will be used for all statistical analyses.
PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data will be reported as missing in the study database. Procedures can sometimes be considered when using statistical methods that fail in the presence of any missing values, or when in the case of multiple-predictor statistical models all the data for an individual would be omitted because of a missing value in one of the predictors. For analyses involving multiple regression analysis, a multiple imputation approach will be considered and used if statistically sound, depending on the proportion and pattern of missing values.
METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection will be assured by verification and cross-check of the case report form (CRF) against the researcher´s records (source document verification). Source document verification will be conducted for 5% of data in subjects. Discrepancies and queries will be generated accordingly in the CRF for online resolution by the researcher at the site. In addition, the CRF data will be reviewed on an ongoing basis for medical and scientific plausibility.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- Brief mentalization-based group psychotherapy, Acceptance and Commitment Therapy group intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mentalization-based group psychotherapyBehavioural
The intervention is an adaptation for anxiety and depression profiles of the introductory group program to Mentalization-Based Treatment for personality disorders.
Sessions program:
- Session 1: Building epistemic trust.
- Session 2: Introduction to mentalization.
- Session 3: Mentalization problems.
- Session 4: Emotions.
- Session 5: Mentalizing emotions.
- Session 6: Attachment relationships.
- Session 7: Attachment and mentalization.
- Session 8: Interpersonal relationships. Mentalizing relationships in the group.
- Session 9: Anxiety, attachment and mentalization.
- Session 10: Depression, attachment and mentalization.
- Session 11: Flexible content depending on pending topics or participants' needs. Preparing for closing
- Session 12: Final balance and closing.
Acceptance and Commitment Therapy group interventionBehavioural
The intervention includes 12 sessions based on Acceptance and Commitment Therapy. Sessions program:
- Session 1: Presentation.
- Session 2: Cognitive defusion
- Session 3: Uncontrollability of thought, emotions and behavior.
- Session 4: Creative Hopelessness.
- Session 5: Mindfulness and acceptance.
- Session 6: Values.
- Session 7: Values and action.
- Session 8: Vital goals.
- Session 9: Goal achievement plan.
- Session 10: Implementation.
- Session 11: Flexible content depending on pending topics or participants' needs. Preparing for closing
- Session 12: Final balance and closing.
| Study group | Role | What they receive |
|---|---|---|
| Brief mentalization-based group psychotherapy | Experimental | Participants will attend mentalization-based psychotherapy group sessions of 12 weekly sessions. Receives: Behavioral: Brief mentalization-based group psychotherapy |
| Acceptance and commitment therapy group intervention | Active comparator | Participants will attend to usual group intervention based on Acceptance and Commitment Therapy of 12 weekly sessions. Receives: Behavioral: Acceptance and Commitment Therapy group intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline anxiety symptoms at 3 months.
Generalized Anxiety Disorder 7-item scale (GAD-7), is a self-report questionnaire used to assess the severity of generalized anxiety disorder symptoms. It consists of seven questions that ask respondents to rate how often they have experienced various anxiety-related symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), allowing for a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity. The Spanish adaptation used in this study has excellent psychometric properties, with a Cronbach's alpha of .94
Measured: At baseline then at 3 months.
Change from baseline depressive symptoms at 3 months.
Patient Health Questionnaire-9 (PHQ-9) is a self-report tool designed to assess the severity of depression symptoms. It consists of 9 questions using a Lykert-type scale from 0 (not at all) to 3 (nearly every day). Respondents are asked to rate how often they have experienced specific symptoms over the past two weeks. The total score can range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: At baseline then at 3 months.
Secondary outcomes (5)
Change from baseline epistemic trust at 3 months.
The Epistemic Trust Questionnaire (QET) is a 24-item self-report scale to assess the clinical characteristics of Epistemic Trust. The items, rated on a 5-point Likert-type scale scale, cover areas related to hypervigilance, curiosity, and expectancy and openness to help. Higher scores on the total scale indicate higher values of ET with a score range between 24 and 120. The original English version show adequate validity and reliability in clinical populations with personality disorder diagnoses and non-clinical populations.
Measured: At baseline then at 3 months.
Change from baseline epistemic trust, Mistrust and Credulity at 3 months
The Epistemic Trust, Mistrust, and Credulity Questionnaire (ETMCQ) is a15-items self-report measure to assess various forms of epistemic stance. The ETMCQ consists of three subscales, namely trust, mistrust, and credulity. Responses were rated across a 7-point Likert scale ranging from "strongly disagree" (= 1) to "strongly agree" (= 7). Each subscale score ranges from 5 to 35, with higher scores indicating greater levels of the respective construct (i.e., higher epistemic trust, mistrust, or credulity). The questionnaire also showed good reliability and validity.
Measured: At baseline then at 3 months.
Change from baseline reflective functioning at 3 months.
The Reflective Functioning Questionnaire (RFQ-8) is an eight-item self-report instrument to evaluate mentalization. It asks subjects to express their agreement with each item on a 7-point Likert scale (ranging from 1 = "completely disagree" to 7 = "completely agree"). Total scores range from 8 to 56, with higher scores indicating greater uncertainty about mental states, and lower scores reflecting more adequate mentalizing functioning. Higher levels of uncertainty regarding mental states were found to be correlated with difficulties in affect regulation, symptoms of psychopathology, interpersonal problems, and attachment anxiety. The spanish validation of the RFQ shows an adequate reliability and validity assessing failures in reflective functioning in general population and personality disorders.
Measured: At baseline then at 3 months.
Change from baseline functional impact at 3 months.
The Work and Social Adjustment Scale (WSAS) is a 5-item self-report scale on functional impairment attributable to an identified mental health problem. The items cover areas related to work, home, social leisure, personal leisure and interpersonal relationships. Scores range from 0 to 40, with higher scores indicating greater functional impairment.The Spanish validation confirm the validity and reliability of the scale.
Measured: At baseline then at 3 months.
Satisfaction with therapy
The Consumer Reports Effectiveness Score (CRES-4) consists of 4 items: a satisfaction question, a question to rate the degree of resolution of the main problem, a question about the emotional state before starting treatment and, finally, a question about the emotional state at the time of answering the CRES-4. From these 4 questions, three components can be extracted that correspond to the perception of change in emotional state, satisfaction and problem solving. The measure yields a total score ranging from 0 to 300, derived from this three components. Higher scores indicate greater perceived treatment effectiveness, while lower scores reflect poorer outcomes.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start28 Apr 2024
- Primary completion29 May 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833567
- Sponsor's protocol ID
- MENT/CE_24
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luyten P, Campbell C, Allison E, Fonagy P. The Mentalizing Approach to Psychopathology: State of the Art and Future Directions. Annu Rev Clin Psychol. 2020 May 7;16:297-325. doi: 10.1146/annurev-clinpsy-071919-015355. Epub 2020 Feb 5.
PubMed 32023093Fonagy P, Luyten P, Allison E, Campbell C. Mentalizing, Epistemic Trust and the Phenomenology of Psychotherapy. Psychopathology. 2019;52(2):94-103. doi: 10.1159/000501526. Epub 2019 Jul 30.
PubMed 31362289Campbell C, Tanzer M, Saunders R, Booker T, Allison E, Li E, O'Dowda C, Luyten P, Fonagy P. Development and validation of a self-report measure of epistemic trust. PLoS One. 2021 Apr 16;16(4):e0250264. doi: 10.1371/journal.pone.0250264. eCollection 2021.
PubMed 33861805Ruiz-Parra E, Manzano-Garcia G, Mediavilla R, Rodriguez-Vega B, Lahera G, Moreno-Perez AI, Torres-Cantero AM, Rodado-Martinez J, Bilbao A, Gonzalez-Torres MA. The Spanish version of the reflective functioning questionnaire: Validity data in the general population and individuals with personality disorders. PLoS One. 2023 Apr 6;18(4):e0274378. doi: 10.1371/journal.pone.0274378. eCollection 2023.
PubMed 37023214Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645Knapen S, Swildens WE, Mensink W, Hoogendoorn A, Hutsebaut J, Beekman ATF. The development and psychometric evaluation of the Questionnaire Epistemic Trust (QET): A self-report assessment of epistemic trust. Clin Psychol Psychother. 2024 Jan-Feb;31(1):e2930. doi: 10.1002/cpp.2930. Epub 2023 Nov 10.
PubMed 37947067
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Mentalization-based Group Psychotherapy for Anxiety and Depression Disorders and Spanish Cultural Adaptation and Validation of the Epistemic Trust Questionnaire (QET)
- ClinicalTrials.gov ID
- NCT06833567
- Acronym / sponsor ID
- MENT/CE_24
- Conditions
- Anxiety Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
This randomized clinical trial aims to evaluate the effects of mentalization-based group psychotherapy in patients diagnosed with anxiety and/or depression disorders. In total 100 users of mental health communitary services will be recruited for this study. Participants will be randomized in two parallel groups: to receive usual acceptance and commitment therapy group intervention (control group) or to receive brief mentalization-based group psychotherapy (intervention group). Participants in the trial will be assessed at baseline and at 3 months.
Detailed description
QUALITY ASSURANCE PLAN. The researchers will review and report the process during the trial covering participant enrolment, consent and eligibility to protect participants, including reporting of harm and completeness, accuracy and timeliness of data collection.
STANDARD OPERATING PROCEDURES. Participants will be identified from community mental health services who meet all the study eligibility criteria (listed in section Eligibility). Participants will be recruited over a period of 20 months by mental health professionals (clinical psychology residents). Community sample for validation will be recruited by social media. Participants will not receive financial reimbursement for taking part in this trial.
DATA DICTIONARY. All variables collected in this study are listed and described in an electronic case report form, with associated guidelines, to ensure consistency in all gathered data. The following data will be collected in this trial:
Sociodemographical data. Anxiety symptoms: Generalized Anxiety Disorder 7-item scale (GAD-7) Depressive symptoms: Patient Health Questionnaire-9 (PHQ-9) Epistemic Trust: Questionnaire Epistemic Trust (QET) Epistemic Trust, Mistrust and Credulity: The Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ).
Reflective functioning: The Reflective Functioning Questionnaire (RFQ-8) Functional impact: The Work and Social Adjustment Scale (WSAS) Satisfaction with therapy: The Consumer Reports Effectiveness Score (CRES-4)
SAMPLE SIZE ASSESSMENT. The study has sensitivity to detect effect sizes that are considered clinically significant (Cohen's d =0.50) for a power of 0.8, an Alpha of 0.05 and an estimated sample of 100 participants. The calculation was performed with the GPower 3.1.9.2 program for a mean difference with a t-test for two independent groups.
For the validation of the QET, taking into account the subject-item ratio of at least 5: 1 (24 items), and considering the minimum number of recommended subjects to perform an Exploratory Factor Analysis, the minimum number of participants must be 150.Thus, estimating losses of 20%, the total number of participants estimated for the validation is n = 180 .
STATISTICS ANALYSIS PLAN. The analysis will be made following an intention-to-treat procedure. The change of means in the primary outcome variable between the two study groups will be analyzed with the Student's t-test for independent samples if the criteria for its application are met. If the criteria for its application are not met, nonparametric tests will be used. For continuous secondary variables, this test will also be used. A multivariate analysis of variance (ANCOVA) will also be considered to introduce any possible covariate that differs between the two comparison groups in the first evaluation. Potential confounding variables will include gender, age, previous level of depression and anxiety, and diagnosis. A 95% confidence level will be used for all comparisons. The R program will be used for all statistical analyses.
PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data will be reported as missing in the study database. Procedures can sometimes be considered when using statistical methods that fail in the presence of any missing values, or when in the case of multiple-predictor statistical models all the data for an individual would be omitted because of a missing value in one of the predictors. For analyses involving multiple regression analysis, a multiple imputation approach will be considered and used if statistically sound, depending on the proportion and pattern of missing values.
METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection will be assured by verification and cross-check of the case report form (CRF) against the researcher´s records (source document verification). Source document verification will be conducted for 5% of data in subjects. Discrepancies and queries will be generated accordingly in the CRF for online resolution by the researcher at the site. In addition, the CRF data will be reviewed on an ongoing basis for medical and scientific plausibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief mentalization-based group psychotherapy | Experimental | Behavioral: Brief mentalization-based group psychotherapyParticipants will attend mentalization-based psychotherapy group sessions of 12 weekly sessions. |
| Acceptance and commitment therapy group intervention | Active comparator | Behavioral: Acceptance and Commitment Therapy group interventionParticipants will attend to usual group intervention based on Acceptance and Commitment Therapy of 12 weekly sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants are 18 years or older.
- Participants have a diagnosis of ICD-10 F32, F33, F34, F41.1, F41.2, F43 or F43.2.
- Participants have minimal relational skills to participate in group therapy.
- Participants agree to be part of the study by giving signed written consent.
Key exclusion criteria (4 listed)
- Participants have a diagnosis of ICD-10 F10-19, F20-29, F31, F42, F43.1, F60.
- Participants with cognitive deficits assessed during the initial interview or diagnosis of ICD-10 F70-79.
- Participants with planning or structured suicidal ideation.
- Participants with difficulties in relational skills evaluated during the initial interview.
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 |
|---|---|---|
| Brief mentalization-based group psychotherapyThe intervention is an adaptation for anxiety and depression profiles of the introductory group program to Mentalization-Based Treatment for personality disorders. Sessions program: * Session 1: Building epistemic trust. * Session 2: Introduction to mentalization. * Session 3: Mentalization problems. * Session 4: Emotions. * Session 5: Mentalizing emotions. * Session 6: Attachment relationships. * Session 7: Attachment and mentalization. * Session 8: Interpersonal relationships. Mentalizing relationships in the group. * Session 9: Anxiety, attachment and mentalization. * Session 10: Depression, attachment and mentalization. * Session 11: Flexible content depending on pending topics or participants' needs. Preparing for closing * Session 12: Final balance and closing. | Behavioural | Brief mentalization-based group psychotherapy |
| Acceptance and Commitment Therapy group interventionThe intervention includes 12 sessions based on Acceptance and Commitment Therapy. Sessions program: * Session 1: Presentation. * Session 2: Cognitive defusion * Session 3: Uncontrollability of thought, emotions and behavior. * Session 4: Creative Hopelessness. * Session 5: Mindfulness and acceptance. * Session 6: Values. * Session 7: Values and action. * Session 8: Vital goals. * Session 9: Goal achievement plan. * Session 10: Implementation. * Session 11: Flexible content depending on pending topics or participants' needs. Preparing for closing * Session 12: Final balance and closing. | Behavioural | Acceptance and commitment therapy group intervention |
Primary outcome
Change from baseline anxiety symptoms at 3 months.
Time frame: At baseline then at 3 months.
Generalized Anxiety Disorder 7-item scale (GAD-7), is a self-report questionnaire used to assess the severity of generalized anxiety disorder symptoms. It consists of seven questions that ask respondents to rate how often they have experienced various anxiety-related symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), allowing for a total score ranging from 0 to 21. Higher scores indicate greater anxiety severity. The Spanish adaptation used in this study has excellent psychometric properties, with a Cronbach's alpha of .94
Change from baseline depressive symptoms at 3 months.
Time frame: At baseline then at 3 months.
Patient Health Questionnaire-9 (PHQ-9) is a self-report tool designed to assess the severity of depression symptoms. It consists of 9 questions using a Lykert-type scale from 0 (not at all) to 3 (nearly every day). Respondents are asked to rate how often they have experienced specific symptoms over the past two weeks. The total score can range from 0 to 27, with higher scores indicating more severe depressive symptoms.
5 secondary outcomes
Change from baseline epistemic trust at 3 months.
Time frame: At baseline then at 3 months.
Change from baseline epistemic trust, Mistrust and Credulity at 3 months
Time frame: At baseline then at 3 months.
Change from baseline reflective functioning at 3 months.
Time frame: At baseline then at 3 months.
Change from baseline functional impact at 3 months.
Time frame: At baseline then at 3 months.
Satisfaction with therapy
Time frame: At 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 32023093Luyten P, Campbell C, Allison E, Fonagy P. The Mentalizing Approach to Psychopathology: State of the Art and Future Directions. Annu Rev Clin Psychol. 2020 May 7;16:297-325. doi: 10.1146/annurev-clinpsy-071919-015355. Epub 2020 Feb 5.
- Background: PubMed 31362289Fonagy P, Luyten P, Allison E, Campbell C. Mentalizing, Epistemic Trust and the Phenomenology of Psychotherapy. Psychopathology. 2019;52(2):94-103. doi: 10.1159/000501526. Epub 2019 Jul 30.
- Background: PubMed 33861805Campbell C, Tanzer M, Saunders R, Booker T, Allison E, Li E, O'Dowda C, Luyten P, Fonagy P. Development and validation of a self-report measure of epistemic trust. PLoS One. 2021 Apr 16;16(4):e0250264. doi: 10.1371/journal.pone.0250264. eCollection 2021.
- Background: PubMed 37023214Ruiz-Parra E, Manzano-Garcia G, Mediavilla R, Rodriguez-Vega B, Lahera G, Moreno-Perez AI, Torres-Cantero AM, Rodado-Martinez J, Bilbao A, Gonzalez-Torres MA. The Spanish version of the reflective functioning questionnaire: Validity data in the general population and individuals with personality disorders. PLoS One. 2023 Apr 6;18(4):e0274378. doi: 10.1371/journal.pone.0274378. eCollection 2023.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
- Background: PubMed 37947067Knapen S, Swildens WE, Mensink W, Hoogendoorn A, Hutsebaut J, Beekman ATF. The development and psychometric evaluation of the Questionnaire Epistemic Trust (QET): A self-report assessment of epistemic trust. Clin Psychol Psychother. 2024 Jan-Feb;31(1):e2930. doi: 10.1002/cpp.2930. Epub 2023 Nov 10.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mentalization-based group psychotherapy and Acceptance and Commitment Therapy group intervention in people with Anxiety Disorders and Depression, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Traverso Rodriguez (+34 660512210, mariatraverso8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline anxiety symptoms at 3 months. (time frame: At baseline then at 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06833567, which also lists 8 linked publications.
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 23 Mar 2026.