Effectiveness of Cognitive Behavior Therapy for Persons With Depression

February 10, 2023 updated by: Dr. Jesan Ara, Rajshahi University

A Randomized Controlled Trial of the Effectiveness of Cognitive Behavior Therapy for Major Depression in Bangladesh

This was a randomized controlled clinical trial (RCT) carried out in three different hospitals in Dhaka city, Bangladesh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a randomized controlled trial, conducted to determine the effectiveness of CBT for depression delivered by trained therapists with an adapted Bengali CBT (BaCBT) manual, as compared to a control group. The main objective of the current study was to examine the efficacy of CBT for persons with major depression in Bangladesh.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
    • Rajshahi
      • Rājshāhi, Rajshahi, Bangladesh, 6205
        • Dr. Jesan ara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with Major Depression
  • Must be able to take therapeutic session

Exclusion Criteria:

  • active suicidal ideation
  • a co-morbid serious health condition
  • with psychotic features
  • currently on medication for depression
  • with an intellectual disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment group

cognitive behavior therapy

  • one session per week
  • six to eight session
Other: cognitive behavior therapy
Psycho-therapeutic intervention
OTHER: Wait list control group
  • waitlist control group
  • offer CBT after completing data collection.
Other: cognitive behavior therapy
Psycho-therapeutic intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Scale
Time Frame: change from baseline to day 42, a separate outcome from day 42 to day 72
Depression Scale to measure depression. The total scale scores range from 30 to 150. Higher scores mean worse outcomes.
change from baseline to day 42, a separate outcome from day 42 to day 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Scale
Time Frame: change from baseline to day 42, a separate outcome from day 42 to day 72
Anxiety Scale, the possible range of scores from 0 to 144 and Higher scores mean worse outcomes.
change from baseline to day 42, a separate outcome from day 42 to day 72
Change in General Health Questionnaire-28
Time Frame: change from baseline to day 42, a separate outcome from day 42 to day 72
General Health Questionnaire-28, range of scores from 0 to 84, and Higher scores mean worse outcomes.
change from baseline to day 42, a separate outcome from day 42 to day 72
Change in Beck Scale for Suicidal Ideation
Time Frame: change from baseline to day 42, a separate outcome from day 42 to day 72
Beck Scale for Suicidal Ideation, range of scores from 0 to 42, and Higher scores mean worse outcomes.
change from baseline to day 42, a separate outcome from day 42 to day 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajshahi University

Collaborators

University Grants Commission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 10, 2018

Primary Completion (ACTUAL)

May 10, 2019

Study Completion (ACTUAL)

May 30, 2019

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

February 10, 2023

First Posted (ACTUAL)

February 13, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-PhD/2017/1985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Analysis of data will be shared through research publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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