Protocol summary

Summary
Goals: 1. To examine effectiveness of GCBT in treatment of depression 2. To compare effectiveness of GCBT with Relaxation training and treatment as usual controls 3. To determine changes to depressive symptoms and negative cognitions when undergoing treatment 5. To determine effects of cohesion on treatment outcome Study Design: 3X3 repeated measures MANOVA IV1: Treatment groups (i.e. GCBT, Relaxation, Control) IV2: Assessment time points (i.e. Pre-treatment, Mid-treatment, Post-treatment) DV: BDI-M, DAS-M, ATQ-M, Visual analogue scale (Proxy for cohesion) Target population: The inclusion criteria for the current study was that participants must have been diagnosed with major depressive disorder in the past two weeks by a psychiatrist, between the ages of 18 to 60 years, is currently receiving pharmacotherapy treatment, able to understand Bahasa Malaysia and have no co-morbid diagnosis of major psychiatric (e.g. schizophrenia, bipolar disorder) or medical disorders (e.g. cancer, HIV). Sample Size: Current analysis showed that a total sample size of 159 was required to ensure that enough power was available to limit the chances of Type II error. For the purposes of the current assessment, an estimated 210 participants would be selected to account for potential losses through dropouts and fatigue.

General information

Acronym
Effectiveness of Group CBT
IRCT registration information
IRCT registration number: IRCT2014102219631N1
Registration date: 2014-11-12, 1393/08/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-12, 1393/08/21
Registrant information
Name
Joel Low
Name of organization / entity
University Putra Malaysia
Country
Malaysia
Phone
+60 12 300 3385
Email address
gs29978@mutiara.upm.edu.my
Recruitment status
Recruitment complete
Funding source
University grant from University Putra Malaysia
Expected recruitment start date
2013-06-01, 1392/03/11
Expected recruitment end date
2014-05-30, 1393/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the Effectiveness of Group Cognitive Behavioural Therapy for the Treatment of Unipolar Depression in Malaysia: A Randomized Controlled Trial
Public title
Examining the Effectiveness of Group Cognitive Behavioural Therapy for the Treatment of Unipolar Depression in Malaysia: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria for the current study was that the participants must have been diagnosed with major depressive disorder in the past two weeks by a psychiatrist, between the ages of 18 to 60 years, is currently receiving pharmacotherapy treatment for unipolar depression, be able to understand Bahasa Malaysia and no co-morbid diagnosis of major psychiatric (e.g. schizophrenia, bipolar disorder) or medical disorders (e.g. cancer, HIV).
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University Putra Malaysia Ethics committee
Street address
University Putra Malaysia, 43400 Serdang, Selangor
City
Serdang
Postal code
43400
Approval date
2012-11-01, 1391/08/11
Ethics committee reference number
04-02-12-2126RU

Health conditions studied

1

Description of health condition studied
Unipolar Depression
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms

Primary outcomes

1

Description
Depressive symptoms
Timepoint
Pre, Mid & Post-treatment
Method of measurement
Beck Depression Inventory-Malay

2

Description
Negative Automatic Thoughts
Timepoint
Pre, Mid & Post-treatment
Method of measurement
Automatic Thought Questionnaire-Malay

3

Description
Dysfunctional Beliefs
Timepoint
Pre, Mid & Post-treatment
Method of measurement
Dysfunctional Attitude Scale-Malay

4

Description
Cohesion
Timepoint
Pre, mid and post-treatment
Method of measurement
Visual Anologue Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: Group Cognitive Behavioural Therapy
Category
Treatment - Other

2

Description
Placebo Control: Relaxation Training
Category
Placebo

3

Description
Control: Treatment as usual
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Kajang
Full name of responsible person
Sister Tillah
Street address
Jalan Semenyih, Bandar Kajang, 43000 Kajang, Selangor
City
Kajang

2

Recruitment center
Name of recruitment center
Hospital Serdang
Full name of responsible person
Head Nurse
Street address
Hospital Serdang, Jalan Puchong, 43000 Kajang, Selangor Darul Ehsan.
City
Serdang

3

Recruitment center
Name of recruitment center
Hospital Kuala Lumpur
Full name of responsible person
Head Nurse
Street address
Jalan Pahang, 50586 Kuala Lumpur, MALAYSIA
City
Kuala Lumpur

4

Recruitment center
Name of recruitment center
Hospital Tengku Ampuan Rahimah
Full name of responsible person
Head Nurse
Street address
Jalan Langat, 41200 Klang, Selangor
City
Klang

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University Putra Malaysia
Full name of responsible person
Dr Firdaus Mukhtar
Street address
University Putra Malaysia
City
Serdang
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Putra Malaysia
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University Putra Malaysia
Full name of responsible person
Joel Low
Position
Researcher/Masters of Clinical Psychology
Other areas of specialty/work
Street address
University Putra Malaysia
City
Serdang
Province
Selangor
Postal code
43400
Phone
0060389466000
Fax
Email
joel.low85@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University Putra Malaysia
Full name of responsible person
Dr. Hjh. Firdaus Mukthar
Position
Senior Lecturer/PhD
Other areas of specialty/work
Street address
University Putra Malaysia
City
Serdang
Province
Selangor
Postal code
43400
Phone
0060389466000
Fax
Email
drfircbt@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University Putra Malaysia
Full name of responsible person
Joel Low
Position
Researcher
Other areas of specialty/work
Street address
University Putra Malaysia
City
Serdang
Province
Selangor
Postal code
43300
Phone
0060389466000
Fax
+603-8946 6000
Email
info@upm.edu.my
Web page address
http://www.upm.edu.my

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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