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Completed

NCT Number: NCT05724680

Effectiveness of Cognitive Behavior Therapy for Persons With Depression

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Jesan ara

Rajshahi, Rajshahi Division, 6205, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavior Therapy

Other

Psycho-therapeutic intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Rajshahi University

Other

Collaborators

  • University Grants Commission

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2023
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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