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Trial Title
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Before
Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Depression in Pakistan: A Randomized Controlled Trial
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Cultural Adaptation and Feasibility Evaluation of Metacognitive Training for Patients with Depression in Pakistan: A Randomized Controlled Trial
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Trial Status
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in_development
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completed
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Abstract
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Before
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.
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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.
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Trial End Date
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January 31, 2023
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December 19, 2022
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Last Published
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June 06, 2022 05:17 AM
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January 23, 2023 05:25 AM
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Study Withdrawn
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No
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Intervention Completion Date
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Before
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October 31, 2022
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Data Collection Complete
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Yes
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Final Sample Size: Number of Clusters (Unit of Randomization)
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60 individuals with depression
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Final Sample Size: Total Number of Observations
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60
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Final Sample Size (or Number of Clusters) by Treatment Arms
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30 participants in both groups: treatment and control group
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Is there a restricted access data set available on request?
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No
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Program Files
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No
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Data Collection Completion Date
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November 14, 2022
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Is data available for public use?
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No
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Intervention (Public)
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Before
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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.
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Primary Outcomes (End Points)
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Before
Severity of depression will be evaluated through Beck Depression Inventory (BDI).
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After
Severity of depression was evaluated through Beck Depression Inventory (BDI).
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Did you obtain IRB approval for this study?
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No
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Yes
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