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.
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.
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.
Parallel
Brief mentalization-based group psychotherapy
BehavioralThe 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
BehavioralThe 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.
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
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
