Clinical trial NCT06833567: Mentalizing and Epistemic Trust in Patients With Anxiety and Depression.
Official title: Brief Mentalization-based Group Psychotherapy for Anxiety and Depression Disorders and Spanish Cultural Adaptation and Validation of the Epistemic Trust Questionnaire (QET)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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) 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline anxiety symptoms at 3 months.
timeFrame: At baseline then at 3 months.
measure: Change from baseline depressive symptoms at 3 months.
timeFrame: At baseline then at 3 months.
Secondary outcomes:
measure: Change from baseline epistemic trust at 3 months.
timeFrame: At baseline then at 3 months.
measure: Change from baseline epistemic trust, Mistrust and Credulity at 3 months
timeFrame: At baseline then at 3 months.
measure: Change from baseline reflective functioning at 3 months.
timeFrame: At baseline then at 3 months.
measure: Change from baseline functional impact at 3 months.
timeFrame: At baseline then at 3 months.
measure: Satisfaction with therapy
timeFrame: At 3 months
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Instituto de Investigacion Biomedica de Malaga - IBIMA
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.