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Effectiveness of Cognitive Behavior Therapy for Persons With Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
cognitive behavior therapy
Sponsored by
Rajshahi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Jesan ara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment group

Wait list control group

Arm Description

cognitive behavior therapy one session per week six to eight session

waitlist control group offer CBT after completing data collection.

Outcomes

Primary Outcome Measures

Change in Depression Scale
Depression Scale to measure depression. The total scale scores range from 30 to 150. Higher scores mean worse outcomes.

Secondary Outcome Measures

Change in Anxiety Scale
Anxiety Scale, the possible range of scores from 0 to 144 and Higher scores mean worse outcomes.
Change in General Health Questionnaire-28
General Health Questionnaire-28, range of scores from 0 to 84, and Higher scores mean worse outcomes.
Change in Beck Scale for Suicidal Ideation
Beck Scale for Suicidal Ideation, range of scores from 0 to 42, and Higher scores mean worse outcomes.

Full Information

First Posted
January 23, 2023
Last Updated
February 10, 2023
Sponsor
Rajshahi University
Collaborators
University Grants Commission
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1. Study Identification

Unique Protocol Identification Number
NCT05724680
Brief Title
Effectiveness of Cognitive Behavior Therapy for Persons With Depression
Official Title
A Randomized Controlled Trial of the Effectiveness of Cognitive Behavior Therapy for Major Depression in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajshahi University
Collaborators
University Grants Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
cognitive behavior therapy one session per week six to eight session
Arm Title
Wait list control group
Arm Type
Other
Arm Description
waitlist control group offer CBT after completing data collection.
Intervention Type
Other
Intervention Name(s)
cognitive behavior therapy
Intervention Description
Psycho-therapeutic intervention
Primary Outcome Measure Information:
Title
Change in Depression Scale
Description
Depression Scale to measure depression. The total scale scores range from 30 to 150. Higher scores mean worse outcomes.
Time Frame
change from baseline to day 42, a separate outcome from day 42 to day 72
Secondary Outcome Measure Information:
Title
Change in Anxiety Scale
Description
Anxiety Scale, the possible range of scores from 0 to 144 and Higher scores mean worse outcomes.
Time Frame
change from baseline to day 42, a separate outcome from day 42 to day 72
Title
Change in General Health Questionnaire-28
Description
General Health Questionnaire-28, range of scores from 0 to 84, and Higher scores mean worse outcomes.
Time Frame
change from baseline to day 42, a separate outcome from day 42 to day 72
Title
Change in Beck Scale for Suicidal Ideation
Description
Beck Scale for Suicidal Ideation, range of scores from 0 to 42, and Higher scores mean worse outcomes.
Time Frame
change from baseline to day 42, a separate outcome from day 42 to day 72

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dr. Jesan ara
City
Rājshāhi
State/Province
Rajshahi
ZIP/Postal Code
6205
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Analysis of data will be shared through research publications.

Learn more about this trial

Effectiveness of Cognitive Behavior Therapy for Persons With Depression

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