Mentalizing and Epistemic Trust in Patients with Anxiety and Depression.

Not Applicable

Recruiting

• Conditions: Anxiety Disorders; Depression

• Registration Number: NCT06833567
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Study Timeline

• Study Start: 2024-04-28
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Primary Completion: 2026-05-29
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline depressive symptoms at 3 months.	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.
Change from baseline anxiety symptoms at 3 months.	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline epistemic trust at 3 months.	At baseline then 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. The original English version show adequate validity and reliability in clinical populations with personality disorder diagnoses and non-clinical populations.
Change from baseline epistemic trust, Mistrust and Credulity at 3 months	At baseline then 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). The questionnaire also showed good reliability and validity.
Change from baseline reflective functioning at 3 months.	At baseline then 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"). 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.
Change from baseline functional impact at 3 months.	At baseline then 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. The Spanish validation confirm the validity and reliability of the scale.
Satisfaction with therapy	At 3 months	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.

Trial Locations

Locations (1)

Instituto de Investigacion Biomedica de Malaga - IBIMA; 🇪🇸 Malaga, Spain