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

Last registered on June 06, 2022

Pre-Trial

General Information

Title

Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for 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.

Locations

Country

Pakistan

Region

Primary Investigator

Name

sundus khattak

Affiliation

Foundation University Islamabad

Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status

In development

Start date

2022-06-01

End date

2023-01-31

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 one of the most common and enfeebling psychiatric disorders as. It affects one in seven persons at some point during their life. Due to the high prevalence rate of depression, Pakistan is on the top list among developing countries. Keeping in view the insufficient amount of mental health professionals, the current psychotherapies need to be revised to meet the present need for intervention in LAMICs like Pakistan. Considering it, the following study proposes the implementation and adaptation of Metacognitive Training for Depression (D-MCT). A new treatment approach based on cognitive-behaviour therapy reduces cognitive biases using a metacognitive perspective. Since it’s a group training which makes it more cost-effective. 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. 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 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 primary outcome measure (severity of depression) will be evaluated through Beck Depression Inventory (BDI). Secondary outcome measures (quality of life, positive mental health, and metacognitions) will be measured through other scales. This study will bring significant benefits for the mental health clinician, and to the general public as it will improve treatment for depression in Pakistan.

External Link(s)

Registration Citation

Citation

khattak, sundus. 2022. "Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Depression in Pakistan: A Randomized Controlled Trial." AEA RCT Registry. June 06. https://doi.org/10.1257/rct.9520-1.0

Sponsors & Partners

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 depression will be 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

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?

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