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

Last registered on May 30, 2022

Pre-Trial

Trial Information

General Information

Title
A Parallel-group, Double-blind, Randomized Controlled Feasibility Trial in Pakistan for Treatment of Schizophrenia through Metacognitive Training for Psychosis
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.

Locations

Region

Primary Investigator

Affiliation
Foundation University Islamabad

Other Primary Investigator(s)

Additional Trial Information

Status
In development
Start date
2022-06-01
End date
2023-01-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
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.
External Link(s)

Registration Citation

Citation
Abbasi, Parsa Waqar. 2022. "A Parallel-group, Double-blind, Randomized Controlled Feasibility Trial in Pakistan for Treatment of Schizophrenia through Metacognitive Training for Psychosis." AEA RCT Registry. May 30. https://doi.org/10.1257/rct.9510-1.0
Experimental Details

Interventions

Intervention(s)
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)
IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials