Interventions to Reduce Psychological Interventions Associated With Infertility in Nigeria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Measurement for absence of psychological morbidities post intervention
研究概览
简要总结
Research Objectives:
- To test the FeLiCiA, a 6 week intervention developed for the management of psychological morbidities associated with infertility, using external randomised control trial methods, on patients showing positive indicators for psychological morbidity amongst patients with infertility at UCH Ibadan, Nigeria.
- To explore and understand patient perspectives on the benefits of the FeLiCiA counselling in addition to usual clinical care.
Summary of Research:
Population:
Sample size N=42 Men & Women (aged 21-45) with GHQ 12 score indicative of mild to moderate psychological morbidities (3 or more) among patients attending University College Hospital for infertility treatment.
Intervention:
FELICIA [N= 21 intervention] 6 weekly counselling Follow up at 6/52 and 6/12. Inclusion Criteria: Age 21-45; Exclusion Criteria: Previously diagnosed mental illness; severe anxiety & depression or suicide intent (immediate referral); Age<21/>45.
Comparison: [N=21 control group] Treatment as usual
Outcome:
Primary-GHQ12 score less than 3 Secondary-
- Sustained GHQ12 score less than 3
- Patient perspectives on benefits and effectiveness of intervention, and patient empowerment post intervention.
详细描述
Eligible participants will be recruited by randomisation into a pilot trial of the intervention. The pilot trial will be in two groups- the intervention group (FELICIA) and the control group (No intervention/ treatment as usual). The intervention group will be see undergo a 6 weekly counselling sessions, using the FELICIA manual to deliver infertility counselling. The counselling sessions are to be delivered by the nurses at the infertility clinic who will be trained by the researcher to deliver this intervention. The FeLiCiA manual was developed by Dr Abiola Aiyenigba who is the principal investigator. FeLiCiA is based on the THINKING HEALTH PROGRAMME developed by Prof Atif Rahman, who will also be supervising the research. Further details are available in the FeLiCiA manual, which is attached to his proposal for further reference.
Semi structure interviews: Qualitative research will be carried out using one to one interviews. Patient will be asked to discuss their views regarding the benefits of the intervention in helping them manage the stresses that they face dealing with infertility.
Study Site:
The study will be carried in the University College Hospital, Ibadan, Nigeria Study Population The study population will consist of patients attending clinics for the treatment of infertility at the University College Hospital, Ibadan, Nigeria
Sampling Method (N=42):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consenting Patients aged between 21 and 45 years attending the infertility outpatient clinics, the Assisted Reproduction clinics and other gynecological, andrology and nephrology clinics for infertility treatment
- •Patients who have been undergoing infertility treatments for over 2 years.
- •Patients who also have a GHQ 12 score of 3 or more.
- •Patients who have been identified having mild to moderate anxiety and/or depression using the psychometric measuring tools that would not qualify to be treated bio-medically.
排除标准
- •Non-consenting patients aged between 21 and 45 years attending the infertility outpatient clinics, the Assisted Reproduction clinics and other gynecological, andrology and nephrology clinics for infertility treatment.
- •Participants with infertility for less than two years.
- •Participants identified as having severe forms of anxiety and depression that require urgent psychiatric treatments/referral.
- •Patients who have previously been clinically diagnosed and treated for with a mental illness.
研究组 & 干预措施
Fertility Life Counselling Aid (FeLiCiA)
Patients to undergo weekly Felicia counselling interventions for 6 weeks; making a total of 6 sessions.
Each session is expected lasts 30 mins to 1 hour.
干预措施: Fertility Life Counselling Aid (FeLiCiA) (Behavioral)
Control
Patients are to undergo treatment as usual.
结局指标
主要结局
Measurement for absence of psychological morbidities post intervention
时间窗: 6 weeks
GHQ 12 score= less than 3 - No psychological morbidities
次要结局
- Explore patient perspective on benefits of intervention using qualitative methods, post intervention.(6 weeks)
- Measurement for sustained absence of psychological morbidities, 6months post intervention(6 months)
研究者
Andrew Weeks MD MRCOG
Professor of International Maternal Health
University of Liverpool