The Effect on Obsessive-Compulsive Beliefs and Symptoms of Metacognition Training Given to Patients With Obsessive Compulsive Disorder (MCT-OCD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Obsessive Beliefs Scale mean score
研究概览
简要总结
Objective: Since Metacognitive Training for Obsessive-Compulsive Disorder (MCT-OCD) targets and interferes with dysfunctional (meta-)cognitive beliefs, metacognitions, cognitive biases and coping strategies that contribute to the development and maintenance of OC symptoms, it is predicted that MCT-OCD can be highly effective on obsessive-compulsive beliefs and symptoms. Therefore, this study aims to examine the effect of metacognitive training (MCT-OCD) given to patients with obsessive-compulsive disorder on obsessive-compulsive beliefs and symptoms.Type of Study: The study was planned as a single-blind randomized controlled trial study. Dependent and Independent Variables of the Research: Dependent Variables: Padua Inventory, Obsessive Beliefs Scale and Beliefs About Rituals Scale mean scores. Independent Variables: Metacognitive Training for Obsessive-Compulsive Disorder. Control Variables: Age, gender, marital status, educational status, medicine use, and hospitalization history. Place of Research: The research will be conducted in the Psychiatry Polyclinic of Gaziantep University Şahinbey Research and Application Hospital in Gaziantep City Center. Population and Sample of the Research: The population of the research will be the patients who received treatment with a diagnosis of OCD according to DSM-5 in the Psychiatry Outpatient Clinic of Gaziantep University Şahinbey Research and Application Hospital at the time of the study, and the sample will consist of individuals who meet the inclusion criteria of the study. In this study, a priori power analysis was performed by using the G Power 3.9.1 program to calculate the sample size. The studies were examined (Miegel et al. 2022) and the expected confidence intervals of the Obsessive Beliefs Scale were determined, while the confidence interval was α=0.05, the power of the test (1-β) was 0.80, the effect size was d=0.6630086, while the experimental group was 37 and the control group was 37. A total of 74 patients were calculated. Considering that there will be losses in the research, it is planned to study with 80 people (40 experimental and 40 control groups).
详细描述
Research Goals:
Goal-1: To determine the obsessive-compulsive beliefs of patients with obsessive compulsive disorder in the experimental and control groups Goal-2: To determine the obsessive compulsive symptom levels of patients with obsessive compulsive disorder in the experimental and control groups Goal-3: Reducing obsessive-compulsive beliefs of patients with obsessive compulsive disorder in the experimental group with the application of metacognitive training Goal-4: Reducing the symptom levels of patients with obsessive compulsive disorder in the experimental group with the application of metacognitive training Goal-5: It is aimed to create high-level evidence to reduce obsessive-compulsive beliefs and symptom level of patients with obsessive compulsive disorder.
Research Hypotheses:
H0: Metacognitive training given to patients with obsessive compulsive disorder has no effect on obsessive-compulsive beliefs and symptom levels of patients in the experimental and control groups.
H1a Hypothesis: Metacognitive training given to patients with obsessive compulsive disorder will decrease the mean obsessive belief scores of the patients in the experimental group compared to the patients in the control group.
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 (Participant)
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
- •Volunteering to participate in the study, Not having a condition that prevents communication, Being between the ages of 18-65, Being followed up with the diagnosis of OCD (Obsession-Compulsive Disorder) according to DSM-5 criteria; Being literate; Not being included in such a training program for the disease in the last 5 years.
排除标准
- •Those diagnosed with another comorbid mental illness; Patients with mental disorders such as intellectual disability or dementia that makes it impossible to cooperate; Patients who are illiterate; Patients who do not consent for the interview.
- •Expulsion Criteria:
- •Patients in the experimental group who want to quit the study during the study period and who do not attend at least two modules/sessions of the training are within the scope of the exclusion criteria.
结局指标
主要结局
Obsessive Beliefs Scale mean score
时间窗: 0-2-5. months
Obsessive Beliefs Scale (AS-44): OBS-44 was developed to identify key cognitions in OCD, consisting of three subscales (exaggerated sense of responsibility/danger expectation, perfectionism/need for certainty, giving importance to thoughts/controlling thoughts). The need for self-report) is a 44-item self-report scale with each item scored between 1 and 7, with higher scores indicating greater belief in those cognitions (OCCWG, 2005). Cut-off scores for this scale were not reported. The Turkish version of the SPQ was also found to be valid and reliable. Boysan et al. (2010) conducted a Turkish validity study and the cronbach α was found to be 0.95.
Beliefs About Rituals Scale mean scores
时间窗: 0-2-5. months
Beliefs About Rituals Scale (BRS): BRS is a 12-item self-report scale that evaluates beliefs about rituals and consists of three subscales (behavior and character change, guilt and loss of functionality, anxiety). Scale items are scored between 1-4. In the scale, a description of the rituals is given first, followed by an example, and the participants are asked what they believe will happen if this ritual is not performed. High scores indicate a high number of beliefs (undesirable character and behavior changes, guilt and loss of functionality, anxiety) that performing rituals prevents the feared consequences. There is no cutoff score. In the original validity and reliability study of the scale, the Cronbach α value was found to be 0.82 (McNicol \& Wells, 2012). The Turkish validity study of the scale was conducted by Güneysu et al. (2020) and Cronbach α = 0.856 was found.
Padua Inventory mean scores
时间窗: 0-2-5. months
PEWEUR is a 39-item self-report scale that evaluates obsessions and compulsions. The Padua Inventory was developed by Sanavio (1988) and Burns et al. (1996) made the PE-WEÜR version. The Turkish validity study of the scale was conducted by Yorulmaz et al. (2007) made by and. The scale is in a five-point Likert type, ranging from 0 = Not at all to 4 = Very much. In scoring the scale, each sub-dimension is scored within itself. The high score obtained from each sub-dimension of the scale indicates that the individual's anxiety level evaluated by the relevant sub-dimension is high. In the Turkish validity and reliability study, PI-WEÜR consists of 5 sub-dimensions: Obsessions and compulsions of checking; Dirty obsessions and cleaning compulsions, Obsessive urges to harm others/self; Regulation, Obsessive thoughts of harming others/self. The cronbach α value of the scale was found to be 0.93 (Yorulmaz et al. 2007).
次要结局
未报告次要终点
研究者
Zeynep Koc
Research Assistant
University of Gaziantep