Fertility Life Counselling Aid- FeLiCiA (NCT03348865) | Clinical Trial Compass
CompletedNot Applicable
Fertility Life Counselling Aid- FeLiCiA
Nigeria16 participantsStarted 2017-11-20
Plain-language summary
Research Objectives:
1. 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.
2. 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-
1. Sustained GHQ12 score less than 3
2. Patient perspectives on benefits and effectiveness of intervention, and patient empowerment post intervention.
Who can participate
Age range21 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Measurement for absence of psychological morbidities post intervention