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Trial Title A Parallel-group, Double-blind, Randomized Controlled Feasibility Trial in Pakistan for Treatment of Schizophrenia through Metacognitive Training for Psychosis Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Schizophrenia in Pakistan: A Parallel, Double Blind, Randomized Controlled Trial
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 Mini International Neuropsychiatric Interview (M.I.N.I.) 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. 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.
Last Published May 30, 2022 08:15 AM August 25, 2022 07:24 AM
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