Effectiveness of Cognitive Behavior Therapy for Persons With Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05724680
• Other study ID #: 24-PhD/2017/1985
• Status: Completed
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: February 2023
• Source: Rajshahi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: May 30, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• cognitive behavior therapy
Psycho-therapeutic intervention

Locations

Country	Name	City	State
Bangladesh	Dr. Jesan ara	Rajshahi	Rajshahi

Sponsors (2)

Lead Sponsor	Collaborator
Rajshahi University	University Grants Commission

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Depression Scale	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	Change in Anxiety Scale	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
Secondary	Change in General Health Questionnaire-28	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
Secondary	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.	change from baseline to day 42, a separate outcome from day 42 to day 72