Effect on Obsessive-Compulsive Beliefs and Symptoms of MCT-OCD

NCT06029738 | Unknown DMC

• 1 other identifier: Ethics Protocol Code: 2022/13
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive Symptoms; Compulsive Symptoms; Obsessive Beliefs; Compulsive Beliefs; Obsessive-Compulsive Disorder; OCD; Metacognitive Training for Obsessive-Compulsive Disorder; MCT-OCD; Randomized Controlled Trial; RCT

Outcome Measures

Primary Outcomes (3)

• Padua Inventory mean scores

  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).

  0-2-5. months

• Obsessive Beliefs Scale mean score

  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.

  0-2-5. months

• Beliefs About Rituals Scale mean scores

  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.

  0-2-5. months

Study Arms (2)

Experimental group

EXPERIMENTAL

Intervention (Metacognitive Education for Obsessive-Compulsive Disorder (MCT-OCD)): MCT-OCD is a group education for OCD patients

Behavioral: Metacognitive Training for Obsessive-Compulsive Disorder (MCT-OCD)

Control group

NO INTERVENTION

Interventions

Metacognitive Training for Obsessive-Compulsive Disorder (MCT-OCD) BEHAVIORAL

MCT-OCD is a group education for OCD patients.

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Gaziantep: lead

Related Publications (7)

• Miegel F, Cludius B, Hottenrott B, Demiralay C, Sure A, Jelinek L. Session-specific effects of the Metacognitive Training for Obsessive-Compulsive Disorder (MCT-OCD). Psychother Res. 2020 Apr;30(4):474-486. doi: 10.1080/10503307.2019.1613582. Epub 2019 May 9.

  PMID: 31072282 BACKGROUND

• Miegel F, Demiralay C, Moritz S, Wirtz J, Hottenrott B, Jelinek L. Metacognitive Training for Obsessive-Compulsive Disorder: a study protocol for a randomized controlled trial. BMC Psychiatry. 2020 Jul 6;20(1):350. doi: 10.1186/s12888-020-02648-3.

  PMID: 32631261 BACKGROUND

• Miegel F, Rubel J, Ching THW, Yassari AH, Bohnsack F, Duwe M, Jelinek L. How to assess and analyse session-specific effects and predictors: An example with the Metacognitive Training for Obsessive-Compulsive Disorder intervention. Clin Psychol Psychother. 2023 Sep-Oct;30(5):1158-1169. doi: 10.1002/cpp.2876. Epub 2023 Jun 8.

  PMID: 37288873 BACKGROUND

• Obsessive Compulsive Cognitions Working Group. Psychometric validation of the obsessive belief questionnaire and interpretation of intrusions inventory--Part 2: Factor analyses and testing of a brief version. Behav Res Ther. 2005 Nov;43(11):1527-42. doi: 10.1016/j.brat.2004.07.010.

  PMID: 16299894 BACKGROUND

• Burns GL, Keortge SG, Formea GM, Sternberger LG. Revision of the Padua Inventory of obsessive compulsive disorder symptoms: distinctions between worry, obsessions, and compulsions. Behav Res Ther. 1996 Feb;34(2):163-73. doi: 10.1016/0005-7967(95)00035-6.

  PMID: 8741724 BACKGROUND

• Sanavio E. Obsessions and compulsions: the Padua Inventory. Behav Res Ther. 1988;26(2):169-77. doi: 10.1016/0005-7967(88)90116-7. No abstract available.

  PMID: 3365207 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

  PMID: 20332509 BACKGROUND

Related Links

• CONSORT 2010, Erişim Tarihi: 28.08.2023.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Zeynep Koç, MsC

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

• Derya Tanrıverdi, Prof.Dr.

  University of Gaziantep

  STUDY DIRECTOR

Central Study Contacts

Zeynep Koc, MsC

CONTACT

+90 (342) 360 1200; zeynepkoc2009@hotmail.com

Derya Tanriverdi, Prof. Dr.

CONTACT

+90 (342) 360 1200; deryalper@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: The research was planned as two groups randomized controlled trial study.

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share