Exploring The Metacognitive Beliefs in OCD: A Randomized Controlled Trial of Metacognitive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score
研究概览
简要总结
Exploring The Metacognitive Beliefs in OCD: A Randomized Controlled Trial of Metacognitive Therapy Introduction Obsessive-Compulsive Disorder (OCD) is a mental health condition characterized by intrusive thoughts (obsessions) and repetitive behaviors (compulsions). These symptoms cause significant distress and impair daily functioning. OCD can be difficult to treat, and relapse rates are high even after conventional treatments. This study evaluates whether Metacognitive Therapy (MCT) is more effective than Treatment as Usual (TAU) in reducing OCD symptoms and improving overall well-being. The study explores how MCT, which targets metacognitive beliefs (thoughts about thoughts), can help manage symptoms more effectively than standard treatments.
Study Goal and Research Question
The primary goal of this study is to assess the effectiveness of Metacognitive Therapy (MCT) compared to Treatment as Usual (TAU) for treating Obsessive-Compulsive Disorder (OCD). The key research question is:
Does Metacognitive Therapy (MCT) reduce OCD symptoms more effectively than Treatment as Usual (TAU)? Study Design
This study is a Randomized Controlled Trial (RCT), which means participants are randomly assigned to one of two treatment groups:
Metacognitive Therapy (MCT): Participants in this group receive a 12-session therapy program that focuses on addressing harmful metacognitive beliefs, such as the need to control thoughts and the belief that thoughts can cause harm.
Treatment as Usual (TAU): Participants in this group receive the standard treatment for OCD, which may include Exposure and Response Prevention (ERP) and/or medication.
Who Can Participate? Adults aged 18 and older who have been diagnosed with OCD are eligible to participate in the study. To be eligible, participants must have moderate to severe OCD symptoms, measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). Individuals with severe mental health conditions other than OCD, such as psychosis or substance use disorders, are excluded from participation. Participants must also be able to attend therapy sessions and complete the necessary assessments throughout the study.
How the Study Was Conducted Randomization: Participants were randomly assigned to either the MCT group or the TAU group.
MCT Group: Participants in the MCT group attended 12 therapy sessions, which focused on changing metacognitive beliefs that contribute to OCD symptoms.
TAU Group: Participants in the TAU group received standard treatment for OCD, which may have included a combination of therapy and medications.
Assessments: Participants were assessed at three time points: before treatment (pre-treatment), immediately after treatment (post-treatment), and six months after treatment (follow-up). These assessments measured changes in OCD symptoms, metacognitive beliefs, and overall quality of life.
Study Procedures and Timeline Pre-Treatment Assessment: Participants completed initial assessments to measure their OCD symptoms, metacognitive beliefs, and quality of life.
Therapy Sessions: Participants in both groups attended their respective therapy sessions (12 sessions for MCT, standard sessions for TAU).
Post-Treatment and Follow-Up Assessments: After the therapy ended, participants completed post-treatment assessments. Six months later, they participated in a follow-up assessment to measure the long-term effectiveness of the treatment.
Important Information for Participants Metacognitive Therapy (MCT) is designed to help people change the way they think about their thoughts, addressing beliefs such as the need to control thoughts or the belief that having certain thoughts can cause harm.
Treatment as Usual (TAU) is the standard treatment for OCD, which may include Exposure and Response Prevention (ERP) therapy or medication management.
Participants in this study can withdraw at any time, and their decision will not affect their treatment or relationship with their healthcare provider.
Expected Benefits If MCT is found to be more effective than TAU, it may offer a new, personalized approach to treating OCD, especially for individuals whose symptoms are driven by dysfunctional metacognitive beliefs. Additionally, since MCT targets the underlying thought processes that maintain OCD symptoms, it may provide longer-lasting symptom relief and reduce the likelihood of relapse compared to standard treatments.
Study Impact This study will provide important insights into whether MCT can provide better outcomes for individuals with OCD compared to standard treatments. If MCT is shown to be effective, it could become a valuable treatment option for those who do not respond well to traditional therapies like ERP. Moreover, MCT's focus on addressing metacognitive beliefs may lead to more durable improvements in OCD symptoms.
详细描述
Introduction:
Obsessive-Compulsive Disorder (OCD) is a chronic, debilitating mental health condition that affects approximately 1-2% of the global population. It is characterized by obsessions, which are intrusive and unwanted thoughts, images, or urges, and compulsions, which are repetitive behaviors or mental acts performed to neutralize or reduce the anxiety caused by the obsessions. These symptoms not only lead to significant personal distress but also impair social, occupational, and academic functioning, severely affecting quality of life.
OCD is considered a complex disorder with a range of symptom severity, from mild and transient symptoms to extreme and persistent disturbances that severely disrupt daily life. The clinical presentation of OCD varies widely, with individuals experiencing different combinations of obsessions and compulsions. For example, some individuals primarily experience contamination fears and engage in cleaning compulsions, while others may have intrusive, violent thoughts associated with compulsions like checking or hoarding. Despite the heterogeneity in symptom presentation, individuals with OCD share a common experience of cognitive intrusiveness, which fuels distress and leads to compulsive behavior aimed at reducing this distress.
While the exact cause of OCD remains unclear, research suggests that the disorder arises from a complex interaction of genetic, neurobiological, and environmental factors. Functional imaging studies have implicated abnormalities in the fronto-striatal circuits, including areas such as the orbital frontal cortex, caudate nucleus, and thalamus, which are involved in cognitive control, impulse inhibition, and habit formation. These abnormalities contribute to dysfunctional cognitive processing, which is thought to lead to the obsessions and compulsions characteristic of OCD.
Standard Treatment Approaches for OCD The most widely recognized treatments for OCD include Cognitive Behavioral Therapy (CBT) and pharmacotherapy, primarily Selective Serotonin Reuptake Inhibitors (SSRIs). Exposure and Response Prevention (ERP), a form of CBT, is considered the gold standard for OCD treatment. ERP involves exposing individuals to feared stimuli or situations (i.e., their obsessions) while preventing them from engaging in the corresponding compulsive behaviors (i.e., the rituals designed to reduce anxiety). This process helps individuals learn that their anxiety decreases naturally over time without the need for compulsions, which ultimately breaks the cycle of obsession and compulsion.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary DSM-5 diagnosis of OCD (confirmed by SCID-5)
- •Age 18-65 years
- •Y-BOCS score ≥16 (moderate-to-severe symptoms)
- •Stable medication regimen (no changes in past 6 weeks)
- •Fluent in Urdu or English
- •Willing to attend all sessions and assessments
排除标准
- •Current psychotic, bipolar, or severe depressive disorder
- •Active substance use disorder requiring treatment
- •Intellectual disability or cognitive impairment
- •Concurrent psychotherapy for OCD
- •Recent medication changes (past 6 weeks)
- •Completed OCD-specific therapy in past 3 months
研究组 & 干预措施
TAU
Treatment as Usual (TAU) consists of 12-week standard outpatient care for OCD, including:
- Psychoeducation about OCD symptoms.
- Supportive counseling (stress management, coping strategies).
- SSRI medication management (if prescribed).
- Simplified exposure exercises (without formal ERP protocols).
- Family involvement in care.
干预措施: MCT (Behavioral)
MCT
Arm Description for "MCT" (Experimental Arm):** "Participants receive 12 weekly sessions of manualized Metacognitive Therapy (MCT) for OCD, delivered by trained clinicians. The intervention targets maladaptive metacognitive beliefs (e.g., thought-action fusion) through: (1) Attention Training Technique, (2) Detached Mindfulness exercises, and (3) behavioral experiments to modify compulsions. Treatment progresses through four phases: psychoeducation, challenging perfectionism, addressing intolerance of uncertainty, and relapse prevention. Primary outcome: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
干预措施: MCT (Behavioral)
结局指标
主要结局
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score
时间窗: Baseline, Week 12 (post-treatment), 6-month follow-up
The Y-BOCS is a 10-item clinician-rated scale (scores 0-40) measuring OCD symptom severity. Higher scores indicate worse symptoms. Assessed at baseline, post-treatment (week 12), and 6-month follow-up. Primary endpoint is baseline to week 12 change.
次要结局
- Change in Metacognitions Questionnaire-30 (MCQ-30) total score(Baseline, Week 12 (post-treatment), 6-month follow-up)
- Change in WHOQOL-BREF global score(Baseline, Week 12 (post-treatment), 6-month follow-up)
研究者
Saeed Anwar
Doctoral student
Northeast Normal University