Mentalizing and Epistemic Trust in Patients With Anxiety and Depression.
NCT ID: NCT06833567
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2024-04-28
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Contextual Therapies and Cognitive Behavioral Therapy as Transdiagnostic Group Interventions for Emotional Disorders
NCT04117464
Brief Evidence-based Psychological Treatments for Emotional Disorders
NCT03286881
Feasibility of a Group Blended Transdiagnostic CBT Protocol for Emotional Disorders
NCT04008576
Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial
NCT02314390
Behavioral Activation for Major Depression With and Without Mindfulness
NCT04768361
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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) Depressice symptoms: Patient Health Questionnaire-9 (PHQ-9) Epistemic Trust: The Epistemic Trust Questionnaire (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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Brief mentalization-based group psychotherapy
Participants will attend mentalization-based psychotherapy group sessions of 12 weekly sessions.
Brief mentalization-based group psychotherapy
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 intervention
Participants will attend to usual group intervention based on Acceptance and Commitment Therapy of 12 weekly sessions.
Acceptance and Commitment Therapy group intervention
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brief mentalization-based group psychotherapy
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 intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Instituto de Investigacion Biomedica de Malaga - IBIMA
Málaga, Malaga, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Fonagy 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.
Campbell 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.
Ruiz-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.
Kroenke 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.
Spitzer 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.
Mundt 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.
Knapen 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. 2023 Nov 10. doi: 10.1002/cpp.2930. Online ahead of print.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MENT/CE_24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.