Clinical and Biological Correlates of Obsessive-Compulsive Disorder and Implementation of an Integrated, Manualized Group Mindfulness-Based Cognitive Therapy Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score.
研究概览
简要总结
The study has two main objectives: (1) to evaluate the acceptability and feasibility of a specialized Mindfulness-Based Cognitive Therapy (MBCT) program for Obsessive-Compulsive Disorder (OCD), delivered via videoconference in a synchronous group format; and (2) to explore the associations between selected clinical and biological markers, OCD severity, and treatment response.
This is an interventional study involving outpatients with a diagnosis of OCD recruited at two participating centers in Italy: IRCCS Fatebenefratelli in Brescia (Center 1) and Centro Terapia Cognitiva e Mindfulness per il DOC in Vicenza (Center 2). Participants will take part in group-based treatment based on the MBCT program for OCD.
Participants recruited at Center 1 will undergo blood and saliva sampling for the molecular analyses planned as part of the study. A healthy control group, matched for age and sex, will also be recruited for comparison in the analyses related to the second objective.
详细描述
Obsessive-Compulsive Disorder (OCD) is a common and potentially disabling psychiatric condition, characterized by intrusive and distressing thoughts (obsessions) and repetitive behaviors or mental acts (compulsions). Cognitive behavioral therapy, particularly exposure and response prevention, is considered a first-line treatment for OCD. However, a proportion of patients continue to experience clinically significant symptoms after treatment, highlighting the need for complementary therapeutic approaches.
Mindfulness-based interventions may help patients develop a less reactive and more accepting relationship with intrusive thoughts, emotions, and bodily sensations, potentially reducing the use of maladaptive strategies such as suppression, neutralization, and compulsions. Preliminary evidence suggests that mindfulness-based approaches may reduce OCD symptoms and may improve the acceptability of exposure-based treatment. However, evidence regarding synchronous, therapist-led online group interventions specifically adapted for OCD remains limited.
This study aims to evaluate the feasibility and acceptability of a specialized Mindfulness-Based Cognitive Therapy (MBCT) program for OCD, delivered online through synchronous videoconferencing. The manualized intervention (Didonna, 2022) integrates mindfulness practices with cognitive behavioral therapy, exposure and response prevention, acceptance, decentering, and self-compassion techniques.
The primary objective is to assess the feasibility and acceptability of the synchronous online intervention. Exploratory objectives are to evaluate changes in OCD symptoms and other clinical variables and to investigate associations between clinical characteristics, treatment response, and selected biological markers.
At least 42 adults aged 18-45 years with a diagnosis of OCD will be recruited at two participating centers in Italy. Participants will attend 11 weekly online group sessions conducted by trained therapists. The intervention may be provided alongside ongoing stable pharmacological treatment and other standard clinical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with OCD.
- •Inclusion Criteria:
- •Diagnosis of obsessive-compulsive disorder (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •Age between 18 and 45 years
- •Stable pharmacological treatment for at least 3 months prior to the start of the experimental intervention
- •No previous experience with mindfulness meditation, or previous mindfulness meditation experience with no practice during the 12 months prior to study enrollment
- •Ability and willingness to provide written informed consent.
排除标准
- •Diagnosis of schizophrenia spectrum or other psychotic disorders, including schizoaffective disorder
- •Diagnosis of bipolar and related disorders
- •Major depressive disorder in an acute phase
- •Active substance use disorder or alcohol use disorder as the primary diagnosis
- •Personality disorders of clinically significant severity
- •Documented major neurocognitive disorder. Neurological conditions or medical conditions with a clinically significant impact on cognitive or mental functioning
- •Previous mindfulness meditation practice within the 12 months prior to study enrollment
- •Inability or unwillingness to provide informed consent
- •Healthy subjects.
- •Inclusion Criteria:
- •Age between 18 and 45 years, with age matching within a maximum difference of ±3 years from the corresponding index patient. In all cases, control participants must be at least 18 years and no older than 48 years
- •Voluntary participation in the study.
- •Ability and willingness to provide written informed consent
- •Exclusion criteria:
- •Age younger than 18 years
- •History of psychiatric disorders, as assessed using the Structured Clinical Interview for DSM-5 Disorders - Clinician Version (SCID-CV)
- •Intellectual developmental disorder.
- •Current substance use disorder or alcohol use disorder
- •Neurological disorders, including Parkinson's disease, major neurocognitive disorders, neurodegenerative syndromes, ataxias, multiple sclerosis, cerebrovascular events (stroke or transient ischemic attack [TIA]), central nervous system neoplasms, epilepsy, history of seizures, or clinically significant tremor
- •Systemic medical conditions (e.g., diabetes mellitus, atherosclerosis, chronic arterial hypertension, or malignancies) requiring pharmacological treatment
- •Current or previous mindfulness meditation practice within the 12 months prior to study enrollment
研究组 & 干预措施
Mindfulness-Based Cognitive Therapy (MBCT) for OCD
Participants will receive a manualized Mindfulness-Based Cognitive Therapy (MBCT) program for obsessive-compulsive disorder (OCD), integrating cognitive-behavioral therapy, exposure techniques, mindfulness, decentering, acceptance, and self-compassion practices.
干预措施: Mindfulness-based Cognitive Therapy for OCD (Behavioral)
结局指标
主要结局
Change from baseline in the Yale-Brown Obsessive Compulsive Scale 2nd version (Y-BOCS-II) total score.
时间窗: Baseline, post-treatment (11 weeks), and 3-month follow-up
The Y-BOCS-II is a clinician-administered semi-structured interview used to assess the presence and severity of obsessive-compulsive disorder (OCD) symptoms. The scale consists of 10 severity items, each rated from 0 (no symptoms) to 5 (extreme symptoms). The total score ranges from 0 to 50, where higher scores indicate greater symptom severity. A decrease in the score reflects clinical improvement.
Recruitment rate
时间窗: From study initiation to completion of recruitment.
Recruitment rate will be calculated as the percentage of eligible participants who enroll in the study among all participants assessed for eligibility.
Treatment dropout rate
时间窗: End of Treatment (Week 11).
Treatment dropout rate will be calculated as the percentage of participants who discontinue treatment before completing the intervention.End of Treatment (Week 11).
Treatment attendance rate
时间窗: End of Treatment (Week 11).
Treatment attendance rate will be calculated as the percentage of scheduled treatment sessions attended by each participant.
Assessment questionnaire completion rate
时间窗: Baseline (Week 0), End of Treatment (Week 11), and Post-Treatment Follow-Up (3 months after treatment completion).
Assessment questionnaire completion rate will be calculated as the percentage of scheduled assessment questionnaires completed by participants.
Treatment satisfaction score
时间窗: End of Treatment (Week 11).
Treatment satisfaction will be assessed using an ad hoc treatment satisfaction questionnaire completed by participants at the end of treatment.
Home mindfulness practice time
时间窗: During treatment (Weeks 1-11) and Post-Treatment Follow-Up (3 months after treatment completion).
Home mindfulness practice time will be assessed as the total amount of time spent practicing mindfulness at home during the treatment and follow-up periods.
Quality of home mindfulness practice
时间窗: At Weeks 4, 8, 12, 20, and 24 from the start of the intervention.
The quality of home mindfulness practice will be assessed using the Practice-Quality-Mindfulness (PQ-M) scale at predefined assessment time points. The PQ-M score will be calculated according to the scoring procedure of the instrument.
次要结局
- Change from baseline in the Beck Depression Inventory-II (BDI-II) total score.(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
- Change from baseline in the Beck Anxiety Inventory (BAI) total score.(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
- Change from baseline in the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-SF) total score.(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
- Change from baseline in the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2) subscale scores.(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
- Change from baseline in Obsessional Beliefs Questionnaire (OBQ-20) score.(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
- Change from baseline in the Self-Compassion Scale-Short Form (SCS-SF) total score.(Baseline, post-treatment (11 weeks), and 3-month follow-up)
- Change from baseline in the Mind-Wandering Questionnaire (MWQ) total score.(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
- Change from baseline in the Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index (GSI)(Baseline, post-treatment (11 weeks), and 3-month follow-up.)
研究者
Mariangela Lanfredi
psychologist
IRCCS Centro San Giovanni di Dio Fatebenefratelli