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Trial Title Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Schizophrenia in Pakistan: A Parallel, Double Blind, Randomized Controlled Trial Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Schizophrenia in Pakistan: A Randomized Controlled Trial
Trial Status in_development completed
Abstract Metacognitive training for psychosis is a group-based program that is particularly targeted at reducing cognitive biases such as jumping to conclusions or overconfidence in errors. Its main purpose is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions. The aim of the current study is to translate and adapt metacognitive training for psychosis according to cultural context, and to evaluate the feasibility and acceptability of delivering metacognitive training to patients with schizophrenia in Pakistan. This study is a parallel two arm, double blinded, feasibility, randomized controlled trial. 60 participants will be enrolled into two groups with 1:1 allocation in each arm. Participants will be selected form a single hospital on the basis of a diagnosis of schizophrenia as evaluated by a psychiatrist with age limit between 18-65 years. However, patients with very severe psychotic symptoms that could impede their understanding of the objectives of the sessions will be excluded. Patients with any comorbid diagnosis along with schizophrenia will also be excluded so as to not to hinder the results. Evaluation will be done at baseline, post treatment, and at one month follow up. The primary outcome measures will be psychotic symptoms based on the Positive and Negative Syndrome Scale (PANSS), and the Symptoms Checklist 90 (SCL-90) to rule out comorbidity. Secondary outcomes will be assessed by WHO Quality of Life scale (WHOQOL-BREF), WHO Disability Assessment Scale (WHODAS 2.0), and the Beck Cognitive Insight Scale (BCIS). The current study will improve schizophrenia treatment in Pakistan. It is a group therapy which makes it more cost effective for a LAMI country like Pakistan. Schizophrenia is a severe global mental health problem. Previous studies have suggested different psychological interventions to reduce the severity of schizophrenia symptoms in developing countries. In Pakistan, there has been a lack of research to address this issue and to introduce a measure to overcome this gap. This study aimed to develop a unique intervention to improve the severity of symptoms in individuals with schizophrenia in Pakistan. The purpose of this research was to cross-culturally validate the Metacognitive Training for psychosis (MCT), and to evaluate the feasibility and acceptability of delivering MCT to individuals with schizophrenia in Pakistan. This study was a pre-post design, parallel two arm, double blinded, feasibility, randomized controlled trial. Sixty participants (experimental group, n=30; control group, n=30) were recruited from the departments of psychiatry of various hospitals across Rawalpindi and Islamabad from August to November 2022. Four instruments (Positive and Negative Syndrome Scale, Beck Cogntive Insight Scale, World Health Organization Disability Assessment Schedule, World Health Organization Quality of Life scale) were used to assess symptom severity, cognitive insight, disability, and quality of life in individuals with schizophrenia. A two-way factorial ANOVA was used to examine the efficacy of MCT in reducing symptom severity, cognitive insight, disability, and quality of life. The results of this study demonstrated that MCT was effective in reducing symptom severity and cognitive insight in patients with schizophrenia as compared to the treatment as usual. On the other hand, the results also revealed that MCT was not significantly effective in improving quality of life and disability in patients with schizophrenia. This study will help improve schizophrenia treatment in Pakistan and create insight in policy makers so they can incorporate this therapy in various hospitals across the country.
Trial End Date January 31, 2023 December 19, 2022
Last Published August 25, 2022 07:24 AM January 20, 2023 12:19 PM
Intervention (Public) Metacognitive Training for Psychosis (MCT) is an intervention program developed by Dr. Steffen Moritz from the University Medical Centre Hamburg-Eppendorf, Germany, and Dr. Todd Woodward from the University of British Columbia, Canada. It is based on the theoretical framework of cognitive behavioral model of schizophrenia but is somewhat different in that it is more focused towards cognitive distortions. MCT aims to change the cognitive infrastructure of delusional ideation (Moritz et al., 2021). First published in 2005, it has been translated into almost 37 languages (Penney et al., 2022). It comprises of eight core modules that target common cognitive errors and problem solving biases in schizophrenia (with two additional modules on self-esteem and dealing with stigma which are optional and may supplement or replace the core modules). These errors and biases may, either on their own or in combination, lead to the establishment of false beliefs to the point of delusions. The aim of the sessions is to raise participants’ awareness of these distortions and to encourage them to critically reflect on, complement, or change their current range of problem solving skills (Moritz et al., 2021). There have been several MCT trials conducted throughout the world, and a meta-analysis done by Penny et al. (2022) suggested that the intervention should be integrated in treatment guidelines for schizophrenia.
Did you obtain IRB approval for this study? No Yes
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Irbs

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IRB Name Foundation University Rawalpindi Campus
IRB Approval Date September 01, 2022
IRB Approval Number FURC/IRB/046
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