Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201902545863137 Date of Approval: 11/02/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF MINDFULNESS-BASED COGNITIVE THERAPY ON THE MANAGEMENT OF DEPRESSION AMONGST PSYCHIATRIC PATIENTS IN SOKOTO, NIGERIA
Official scientific title EFFECTIVENESS OF MINDFULNESS-BASED COGNITIVE THERAPY ON THE MANAGEMENT OF DEPRESSION AMONGST PSYCHIATRIC PATIENTS IN SOKOTO, NIGERIA: RCT
Brief summary describing the background and objectives of the trial Background Depression is a common and debilitating disorder with major impact on mental health, it affect a great population in the world. The high prevalence of depression has headed to it being labelled the “common cold” of mental disorder (Weiten, 2004). Depression is a gigantic problematic for societies due to the direct costs of health care and a source of disability. In addition, the prevalence of disability caused by depression is on the rise, as indicated by the World health organization (WHO), which reported that depression was the fourth leading cause of disability worldwide in 1990, and will become the second leading above all non-infectious diseases after ischemic heart disease by 2020 (Murry & Lopez, 1996). Depression is a major public health problem worldwide (Baxter et al., 2014; Ferrari et al., 2013). With a lifetime prevalence of 16.6% (Kessler, 2005), it causes much distress and psychosocial disability (Judd, 2000; NICE, 2009). In 2004, depression accounted for 33% of, and was the most expensive, psychiatric disease in Europe (Kaplan & Laing, 2004) with a total annual estimated cost of €118 billion (Sobocki, Angst, Jonsson & Rehnberg, 2006). According to WHO major depressive disorder (MDD) is now the leading cause of disease burden in middle- and high-income countries, and it is anticipated to be so worldwide by the year 2030 (WHO, 2008). Objectives Main Objective To examine the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) on the management of Depression among the Psychiatric Patients. Specific Objectives 1. To assess the baseline knowledge, attitude and practice of meditation exercise among the patients with depressions in Sokoto 2. To determine the effectiveness of an MBCT on the treatment outcome of Depression (hopelessness, sense of worth, a sense of guilt,) after the intervention 3. To assess the effect of MBCT on the knowledge, attitude and practice of meditation exercise among patients after the intervention
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychotherapy
Anticipated trial start date 01/07/2019
Actual trial start date
Anticipated date of last follow up 02/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mindfulness Based Cognitive Therapy 8 weeks MBCT for depression was developed by Segal, Williams, and Teasdale (2002, 2013), cognitive behavioral therapists and researchers. They were interested in developing a nonpharmacological intervention that would prevent relapse in depression. Recognizing that many patients do not have access to individual cognitive behavioral therapy (CBT), they were particularly interested in an intervention that could be delivered in a group. Mindfulness-Based Cognitive Therapy Process The MBCT treatment consist of 8 sessions and will be adopted from Segal et al., (2002) by the researcher. General rules and guidelines for conducting MBCT: the rules and guidelines are needed to keep the sessions active, enjoyable, and free from stress. Therefore, it is paramount for the group to follow these rules, and the group leader will remind them about the rules if necessary. These rules are listed as follows: 1. All members should have equal time to participate in the group activities. The therapist is responsible to encourage each person to talk and share the idea(s). 2. Confidentiality is very vital. The members are not allowed to reveal personal information and any specific details about each other. 3. Personal things that members talk about in the group are not to be outside of the group 4. Supporting each other in the group. The members should focus on positive aspects of what others are doing or saying. They are not allowed to be critical of each other. Caring and respecting the other members of their group is encouraged. 5. The importance of doing assigned homework is emphasized 6. Regular attendance at the session is stressed out 7. Rational for setting the agenda explained 43
Control Group Wishlist 8 weeks The respondents in the control group condition (Flannery-Schroeder, Choudhury & Kendall, 2005) will attend the information session and will be familiarized with the goals of the research. They are not receiving any treatment and education. The group will include people who are depressed at one of the two locations selected for the study. They will be invited for the evaluation of the level of the BDI-II depression, disability and suicidal ideation at the beginning of the process. 43 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(a) Age 18-60 (b) Met BDI-II score of 14 or more (c) Met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV, 1994) criteria for major depression based on structured interviews by a clinical psychologist (d) A history of suicidal ideation (including thoughts of methods of suicide) or suicidal behavior (e) Completed pre-treatment assessment (a) Below 18 years of age (b) Current psychiatric treatment, e.g. Psychotherapy, supportive groups, anti-psychotic medications Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
(a) Age 18-60 (b) Met BDI-II score of 14 or more (c) Met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV, 1994) criteria for major depression based on structured interviews by a clinical psychologist (d) A history of suicidal ideation (including thoughts of methods of suicide) or suicidal behavior (e) Completed pre-treatment assessment (a) Below 18 years of age (b) Current psychiatric treatment, e.g. Psychotherapy, supportive groups, anti-psychotic medications Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/04/2019 JAWATANKUASA ETIKA UNIVERSITI UNTUK PENYELIDIKAN MELIBATKAN MANUSIA
Ethics Committee Address
Street address City Postal code Country
RESAERCH AND INNOVATION UNIVERSITI PUTRA SERDANG SELANGOR MALAYSIA Selangor 43400 Malaysia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/03/2019 Research and Ethics Committee Usman Danfodio University Teaching Hospital Sokoto
Ethics Committee Address
Street address City Postal code Country
Gawon Nama Area, Sokoto State Nigeria. Sokoto 2370 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/03/2019 Research and Ethics Committee Federal Neuropsychiatry Hospital Kware Sokoto
Ethics Committee Address
Street address City Postal code Country
Along Illela Road Kware Town, Sokoto State Nigeria 2196 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Testing 1 year from now
Secondary Outcome Testing 2 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Usman Danfodio Uninersity Teaching Hospital Sokoto Gawon Nama Area Wamakko Local Government Sokoto State Nigeria
Federal Neuropsychiatry Hospita Kware Sokoto Nigeria Along Kware Illela Federal Road Kware Local Government Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Usan Danfodio University Sokoto Gawon Nama Area, Sokoto State Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Usman Danfodio University Sokoto Dundaye Village Sokoto State Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Associate Prof. SOH KIN LAM Serdang Selangor Malaysia
Associate Prof. Firdaus Bintu Mukhtar Serdang Selangor Malaysia
Dr. SOH KWONG YAN Serdang selangor Malaysia
Dr. Tajudeen Olalekan OLADELE Kware Area Sokoto Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zulkiflu Musa Argungu zeekteema@gmail.com +601157511737 Gawon Nama Area Sokoto
City Postal code Country Position/Affiliation
Sokoto Nigeria Lectuer
Role Name Email Phone Street address
Scientific Enquiries SOH KIN LAM sklam@upm.edu.my +60199369893 Serdang
City Postal code Country Position/Affiliation
Selangor Malaysia Lecturer
Role Name Email Phone Street address
Public Enquiries Tajudeen Olalekan OLADELE droladeleto@gmail.com +2348182179529 Kwasai village behind bafarawa estate old airport Sokoto.
City Postal code Country Position/Affiliation
Sokoto State Nigeria Consultant Psychiatrist at Federal Neuropsychiatry Hospital Kware Sokoto Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information