NCT05724680

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 23, 2023

Last Update Submit

February 10, 2023

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Anxiety Scale

    change from baseline to day 42, a separate outcome from day 42 to day 72

  • Change in General Health Questionnaire-28

    change from baseline to day 42, a separate outcome from day 42 to day 72

  • Change in Beck Scale for Suicidal Ideation

    change from baseline to day 42, a separate outcome from day 42 to day 72

Study Arms (2)

Treatment group

EXPERIMENTAL

cognitive behavior therapy * one session per week * six to eight session

Other: cognitive behavior therapy

Wait list control group

OTHER

* waitlist control group * offer CBT after completing data collection.

Other: cognitive behavior therapy

Interventions

cognitive behavior therapyOTHER

Psycho-therapeutic intervention

Treatment groupWait list control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Jesan ara

Rajshahi, Rajshahi Division, 6205, Bangladesh

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 13, 2023

Study Start

August 10, 2018

Primary Completion

May 10, 2019

Study Completion

May 30, 2019

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

BA(1)