DepressionNCT05724680
Effectiveness of Cognitive Behavior Therapy for Persons With Depression
A study testing cognitive behavior therapy in people with Depression, run by Rajshahi University at 1 site in Bangladesh.
Trial summary
This was a randomized controlled clinical trial (RCT) carried out in three different hospitals in Dhaka city, Bangladesh. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- cognitive behavior therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Aug 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed with Major Depression
- Must be able to take therapeutic session
Who cannot join
- active suicidal ideation
- a co-morbid serious health condition
- with psychotic features
- currently on medication for depression
- with an intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- cognitive behavior therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavior therapyOther
Psycho-therapeutic intervention
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | cognitive behavior therapy
* one session per week
* six to eight session Receives: Other: cognitive behavior therapy |
| Wait list control group | Other | * waitlist control group
* offer CBT after completing data collection. Receives: Other: cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Scale
Depression Scale to measure depression. The total scale scores range from 30 to 150. Higher scores mean worse outcomes.
Measured: change from baseline to day 42, a separate outcome from day 42 to day 72
Secondary outcomes (3)
Change in Anxiety Scale
Anxiety Scale, the possible range of scores from 0 to 144 and Higher scores mean worse outcomes.
Measured: change from baseline to day 42, a separate outcome from day 42 to day 72
Change in General Health Questionnaire-28
General Health Questionnaire-28, range of scores from 0 to 84, and Higher scores mean worse outcomes.
Measured: change from baseline to day 42, a separate outcome from day 42 to day 72
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.
Measured: change from baseline to day 42, a separate outcome from day 42 to day 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start10 Aug 2018
- Primary completion10 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajshahi University
- Sponsor type
- University, hospital or other
- Collaborators
- University Grants Commission
- Responsible party
- Principal investigator, Dr. Jesan Ara, Rajshahi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724680
- Sponsor's protocol ID
- 24-PhD/2017/1985
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Analysis of data will be shared through research publications.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Cognitive Behavior Therapy for Major Depression in Bangladesh
- ClinicalTrials.gov ID
- NCT05724680
- Acronym / sponsor ID
- 24-PhD/2017/1985
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Rajshahi UniversityUniversity, hospital or other
- Collaborators
- University Grants Commission
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: cognitive behavior therapycognitive behavior therapy * one session per week * six to eight session |
| Wait list control group | Other | Other: cognitive behavior therapy* waitlist control group * offer CBT after completing data collection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with Major Depression
- Must be able to take therapeutic session
Key exclusion criteria (5 listed)
- active suicidal ideation
- a co-morbid serious health condition
- with psychotic features
- currently on medication for depression
- with an intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavior therapyPsycho-therapeutic intervention | Other | Treatment group, Wait list control group |
Primary outcome
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.
3 secondary outcomes
Change in Anxiety Scale
Time frame: 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
Change in Beck Scale for Suicidal Ideation
Time frame: change from baseline to day 42, a separate outcome from day 42 to day 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Undecided. Analysis of data will be shared through research publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavior therapy in people with Depression, run by Rajshahi University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression Scale (time frame: change from baseline to day 42, a separate outcome from day 42 to day 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.