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

Last registered on January 23, 2023
View Trial History

Pre-Trial

Trial Information

General Information

Title
Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Depression in Pakistan: A Randomized Controlled Trial
RCT ID
AEARCTR-0009520
Initial registration date
May 31, 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
June 06, 2022, 5:17 AM EDT

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

Last updated
January 23, 2023, 5:25 AM EST

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

Locations

Country
Pakistan
Region

Primary Investigator

Name
sundus khattak
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
Education, Health
Additional Keywords
Metacognitive Training for Depression, Metacognition, Feasibility trial
JEL code(s)
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Depression is the leading cause of disability worldwide. According to the United Nations health agency, it affects more than 300 million people around the world. Previous studies have suggested different psychological interventions to reduce the severity of depression symptoms in developing countries. In Pakistan, there has been a lack of research to address this issue and introduce measures to overcome this gap. This study aimed to develop an intervention to improve the severity of symptoms in individuals with depression in Pakistan. The purpose of this research was to cross-culturally validate the Metacognitive Training for Depression (D-MCT) and evaluate the feasibility and acceptability of delivering D-MCT to individuals within 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 a hospitals in Rawalpindi from August to November 2022. Four instruments (Beck Depression Inventory, Metacognitions Questionnire-30, Mental Health Curriculum-Short Form and World Health Organization Quality of Life scale) were used to assess symptom severity, metacognitions, mental health, and quality of life in individuals with depression. A two-way factorial ANOVA was used to examine the efficacy of D-MCT in reducing symptom severity, metacognitions, mental health, and quality of life. The results of this study demonstrated that D-MCT was effective in reducing symptom severity, maladaptive metacognitions in patients with depression as compared to the treatment as usual. On the other hand, the results also revealed that D-MCT was effective in improving quality of life and mental health in patients with depression. This study will help improve depression 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
khattak, sundus. 2023. "Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Depression in Pakistan: A Randomized Controlled Trial." AEA RCT Registry. January 23. https://doi.org/10.1257/rct.9520-2.0
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
Metacognitive Training for Depression (D-MCT) is an intervention program given by Lena Jelinek and Steffen Moritz. It is a new treatment approach based on Cognitive-behavior therapy that endorses a metacognitive perspective for the alteration of biases in thought and unhealthy beliefs. D-MCT is easy to administer and highly accepted by the patients (Jelinek et al., 2016). D-MCT is the first standardized treatment approach focused on the metacognitive viewpoint that systematically tackles various depression-related cognitive biases. It focuses on dysfunctional metacognitive coping mechanisms (such as thought suppression and rumination) to address disorder-specific cognitive biases (Hasson-Ohayon & Lysaker, 2021). D-MCT has been translated in more than 10 languages and has been conducting since 2009. Through creative techniques, metacognitive training for depression aims to educate participants about the incorrect thought patterns frequently present in depression. It is a standardize treatment approach, consisting of eight modules in form of power point slides along with homework worksheets.
Intervention Start Date
2022-09-01
Intervention End Date
2022-10-31

Primary Outcomes

Primary Outcomes (end points)
Severity of depression was evaluated through Beck Depression Inventory (BDI).
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Quality of life:WHO Quality of Life scale (WHOQOL-BREF)
Positive mental health: Positive Mental Health Scale(PMH)
Metacognitions:Metacognitions Questionnaire 30 (MCQ-30)
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
The following study proposes the implementation and adaptation of Metacognitive Training for Depression (D-MCT) in Pakistan. A new treatment approach based on cognitive-behaviour therapy reduces cognitive biases using a metacognitive perspective. This study aims to translate and culturally adapt D-MCT and carry out a feasibility evaluation of the intervention. Moreover, this study will also evaluate the acceptability of D-MCT for depressive patients in Pakistan. The proposed research will use a double-blind, parallel two-arm trial design. A sample of 60 participants will be selected from a hospital located in Islamabad. The participants will be randomized into intervention and control arms (1:1 allocation in each arm). Participants in the intervention group will receive D-MCT and medication through mental health professionals, who will receive proper training before the implementation. Participants in the control group will receive Treatment-as-usual (TAU) provided by a mental health professional. The evaluation will be done at baseline (pre-assessment) and endpoint (post-assessment) and one-month follow-up. The following research study will follow the UK Medical Research Council Framework for Developing and Evaluating Complex Interventions. To improve the quality and transparency of reporting the respective RCT, the Consolidated Standards of Reporting Trials (CONSORT) will be used to guide the design. The primary outcome measure (severity of depression) will be evaluated through Beck Depression Inventory (BDI). Secondary outcome measures (quality of life, mental health, and metacognitions) will be measured through other scales. This study will bring significant benefits for the clinician, as well as for the general public.
Randomization Method
Randomization is done in-office by a random number generator.
Randomization Unit
individual
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
data will be collected from a single hospital.
Sample size: planned number of observations
60 individuals diagnosed with depression.
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 participants
Compensatory/control group/arm= 30 participants
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

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

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 14, 2022, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
60 individuals with depression
Was attrition correlated with treatment status?
Final Sample Size: Total Number of Observations
60
Final Sample Size (or Number of Clusters) by Treatment Arms
30 participants in both groups: treatment and control group
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
No
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials