Brief Mentalization-based Group Psychotherapy for Anxiety and Depression Disorders and Spanish Cultural Adaptation and Validation of the Epistemic Trust Questionnaire (QET)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline anxiety symptoms at 3 months.
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are 18 years or older.
- •Participants have a diagnosis of ICD-10 F32, F33, F34, F41.1, F41.2, F43 or F43.
- •Participants have minimal relational skills to participate in group therapy.
- •Participants agree to be part of the study by giving signed written consent.
排除标准
- •Participants have a diagnosis of ICD-10 F10-19, F20-29, F31, F42, F43.1, F
- •Participants with cognitive deficits assessed during the initial interview or diagnosis of ICD-10 F70-
- •Participants with planning or structured suicidal ideation.
- •Participants with difficulties in relational skills evaluated during the initial interview.
结局指标
主要结局
Change from baseline anxiety symptoms at 3 months.
时间窗: 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.
时间窗: 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.
次要结局
- Satisfaction with therapy(At 3 months)
- Change from baseline epistemic trust at 3 months.(At baseline then at 3 months.)
- Change from baseline epistemic trust, Mistrust and Credulity at 3 months(At baseline then at 3 months.)
- Change from baseline reflective functioning at 3 months.(At baseline then at 3 months.)
- Change from baseline functional impact at 3 months.(At baseline then at 3 months.)