An interventional study of Fertility Life Counselling Aid (FeLiCiA) in Infertility/Sterility, Psychological Distress and Psychological Stress, sponsored by Andrew Weeks MD MRCOG. Completed at 1 site in Nigeria. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-07-29.
Sponsored by Andrew Weeks MD MRCOG · Not applicable, Interventional, and Supportive care
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Research Objectives:
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-
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):
For the external pilot RCT for testing the FeLiCiA intervention, thirty-eight patients are required to have an 80% chance of detecting, as significant at 5% level, an increase in the primary outcome measure from 5% in the control group to 40% in the experimental group. We increase this sample size by 10% to account for drop out during the 6 weeks, making up a total of 42 patients to be recruited for the trial.
Randomization:
The participants who have consented to participate in the research will be randomized into 2 groups - the Intervention group and the Control Group. The randomization is blinded and allocated using sealed opaque envelopes. The envelopes have been prepared by an independent person; all those carrying out the research have no idea what the contents of the envelopes indicate.
Patients who are eligible and wish to continue with the research will be handed a brown sealed envelope, opened for the first time in the presence of the participant. Depending on the content of the envelope patients will be randomized into either the intervention or control group.
The intervention group will receive the FeLiCiA counselling intervention while the Control group will receive treatment as usual. Counselling sessions will take place via discussion once every week for six weeks. Each counselling session will last no more than 1 hour. Interviews will also take place at the 2 follow up periods at the end of the sis weeks counselling and six months post counselling. (See follow up procedure).
Semi structure interviews:
Participants recruited for the qualitative study (one to one interviews) will be interviewed on one occasion for one to one qualitative research. An interview sessions is expected to last no more than 1 hour.
2,087 studies on the registry are indexed under Infertility; 355 are open to participants now.
This study's enrollment of 16 is below the median of 134 across 1,413 interventional studies indexed under Infertility.
Browse Infertility studies →Andrew Weeks MD MRCOG is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Fertility Life Counselling Aid (FeLiCiA)
Patients are to undergo treatment as usual.
The FeLiCiA study is a pilot randomised control trial study of an intervention that uses cognitive behavioral therapy (CBT) method to provide counselling for infertility patients within low resource settings. this intervention is designed for management of the psychological problems associated with having infertility. It is based on the Thinking Healthy Programme by WHO.
Measurement for absence of psychological morbidities post intervention
GHQ 12 score= less than 3 - No psychological morbidities
Time frame: 6 weeks
Explore patient perspective on benefits of intervention using qualitative methods, post intervention.
One to one semi structured interviews to gain patient perspectives on 1. benefits of intervention, and 2. Patient feelings of empowerment post intervention
Time frame: 6 weeks
Measurement for sustained absence of psychological morbidities, 6months post intervention
GHQ 12 score= less than 3 - No psychological morbidities
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Mar 2018, 4 months.
Of 386 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 4 months is below that.
Counting every sponsor, half of 417 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Andrew Weeks MD MRCOG