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.: PACTR201901892865101 Date of Approval: 21/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title RADIANT STUDY PROTOCOL
Official scientific title Reducing Anxiety and Depression in Infertility among Nigerian Women: An exploratory psycho-educational intervention Trial
Brief summary describing the background and objectives of the trial Infertility is defined as the inability of a couple of child-bearing age to achieve conception after more than 12 months of exposure to regular, unprotected coitus. It affects about 80 million people worldwide, and is often associated with societal pressure, especially in Africa and parts of Asia, where a lot of premium is placed on the ability to have children. Although men and women with infertility experience the emotional and psychological impacts of these pressure, women are disproportionately affected. Anxiety and depression are emotional consequences of the stigma and discrimination experienced by these women, on account of their difficulties with achieving conception. Studies have shown that the presence of high levels of anxiety and depression by itself, alters the hormonal system and further reduces the chances of achieving conception. There is evidence from other climes to indicate that psycho-social interventions are effective for reducing anxiety and depression in women with infertility challenges. But we currently have no evidence that such interventions are efficacious in this environment. Research question Can culturally relevant psycho-educational interventions result in a reduction of symptoms of anxiety and depression among women with infertility? Objective: This study aimed to develop content for a culturally relevant psycho-educational intervention package and to evaluate its effectiveness in the reduction of symptoms of anxiety and depression among women with infertility.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RADIANT
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Education /Training
Anticipated trial start date 11/09/2017
Actual trial start date 18/09/2017
Anticipated date of last follow up 24/11/2017
Actual Last follow-up date 19/10/2018
Anticipated target sample size (number of participants) 114
Actual target sample size (number of participants) 180
Recruitment status Completed
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Video of Psychoeducational intervention once 1 hour screening of a psycho-educational video that utilizes drama to explain infertility, myths, misconceptions, stigma, psycho-social problems (especially anxiety and depression), causes, treatment options, coping mechanisms and resiliency skills. This will be screened at baseline, followed by an interaction with experts (gynaecologists and psychiatrists) 57 Active-Treatment of Control Group
Control Group Control group once 30 minutes to 1 hour treatment as usual comprising of health talks by the public health nurses, as well as the explanations and counseling provided by the managing physicians 57 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female adults aged 18 years and above, who have been trying to conceive for at least one year Any female who has a child Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Female
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
Yes 01/02/2017 Ethics Committee of the Univeristy of Ibadan
Ethics Committee Address
Street address City Postal code Country
College of Medicine, University of Ibadan Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Depressive symptoms 0 weeks 3 weeks 6 weeks
Primary Outcome Anxiety symptoms 0 weeks 3 weeks 6 weeks
Secondary Outcome overall quality of life Baseline
Secondary Outcome quality of family functioning and support Baseline
Secondary Outcome self esteem Baseline
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road, Oritamefa Ibadan 200212 Nigeria
Adeoyo Maternity Hospital Yemetu Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Translational Research and Fellowship Grant (Grant number: CTR16A00-1) College of Medicine, University of Ibadan Ibadan Nigeria
Translational Research and Fellowship Grant (Grant number: CTR16A00-1) College of Medicine, University of Ibadan Ibadan Nigeria
Translational Research and Fellowship Grant (Grant number: CTR16A00-1) College of Medicine, University of Ibadan Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine University of Ibadan College of Medicine, University College Hospital, Queen Elizabeth Road Ibadan 200212 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jibril Abdulmalik jfutprints@yahoo.com +2348073839840 Department of Psychiatry, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria
Role Name Email Phone Street address
Public Enquiries Olufunke Ayodeji funke08@yahoo.com +2348074384518 Department of Psychiatry, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria
Role Name Email Phone Street address
Scientific Enquiries Jibril Abdulmalik jfutprints@yahoo.com +2348073839840 Department of Psychiatry, College of Medicine, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan 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
Changes to trial information