Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Schizophrenia in Pakistan: A Randomized Controlled Trial

Last registered on January 20, 2023
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Pre-Trial

Trial Information

General Information

Title
Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Schizophrenia in Pakistan: A Randomized Controlled Trial
RCT ID
AEARCTR-0009510
Initial registration date
May 29, 2022

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 30, 2022, 8:15 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
January 20, 2023, 12:21 PM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
Pakistan
Region

Primary Investigator

Name
Parsa Waqar Abbasi
Affiliation
Foundation University Islamabad
Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2022-06-01
End date
2022-12-19
Keywords
Health
Additional Keywords
Metacognitive Training, Schizophrenia, Feasibility, Randomized Controlled Trial, Cultural Adaptation
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
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.
External Link(s)

Registration Citation

Citation
Abbasi, Parsa Waqar. 2023. "Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Schizophrenia in Pakistan: A Randomized Controlled Trial." AEA RCT Registry. January 20. https://doi.org/10.1257/rct.9510-3.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
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.
Intervention Start Date
2022-09-01
Intervention End Date
2022-10-31

Primary Outcomes

Primary Outcomes (end points)
Severity of psychotic symptoms will be evaluated through Positive and Negative Syndrome Scale (PANSS).
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Quality of Life: WHO Quality of Life scale (WHOQOL-BREF)
Functioning: WHO Disability Assessment Scale (WHODAS 2.0)
Cognitive Insight: Beck Cognitive Insight Scale (BCIS)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Study design: Pre and Post Follow-up/Baseline design.
Trial design: A Parallel two-arm, Double-blind, feasibility randomized controlled trial
Experimental Design Details
Randomization Method
Randomization is done in office by random number generator.
Randomization Unit
Individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
None
Sample size: planned number of observations
60 individuals diagnosed with schizophrenia
Sample size (or number of clusters) by treatment arms
60 participants will be divided into 2 groups/arms (1:1 allocation in each arm):
Intervention group/arm= 30 students
Compensatory/control group/arm= 30 students
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Foundation University Rawalpindi Campus
IRB Approval Date
2022-09-01
IRB Approval Number
FURC/IRB/046
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
October 31, 2022, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
November 15, 2022, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
60 patients with schizophrenia
Was attrition correlated with treatment status?
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
30 participants in both groups
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials