Infertility/SterilityFeLiCiANCT03348865
Fertility Life Counselling Aid- FeLiCiA
A study testing Fertility Life Counselling Aid (FeLiCiA) in people with Infertility/Sterility and Psychological Distress, run by Andrew Weeks MD MRCOG at 1 site in Nigeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Infertility/Sterility, Psychological Distress, Psychological Stress
- What is being tested?
- Fertility Life Counselling Aid (FeLiCiA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNigeria
- Study dates
- 20 Nov 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Reduce Psychological Interventions Associated With Infertility in Nigeria.
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Infertility/Sterility, Psychological Distress, Psychological Stress, Anxiety Disorders, Depressive Disorder
- Being tested
- Fertility Life Counselling Aid (FeLiCiA)
- Keywords
- Cognitive Behavioural Therapy
- Medical subject headings
- Infertility, Stress, Psychological, Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility Life Counselling Aid (FeLiCiA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Fertility Life Counselling Aid (FeLiCiA) | Experimental | 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. Receives: Behavioral: Fertility Life Counselling Aid (FeLiCiA) |
| Control | No intervention | Patients are to undergo treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement for absence of psychological morbidities post intervention
GHQ 12 score= less than 3 - No psychological morbidities
Measured: 6 weeks
Secondary outcomes (2)
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
Measured: 6 weeks
Measurement for sustained absence of psychological morbidities, 6months post intervention
GHQ 12 score= less than 3 - No psychological morbidities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start20 Nov 2017
- Primary completion27 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility/SterilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Weeks MD MRCOG
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, University College Hospital, Ibadan, Nigeria
- Responsible party
- Sponsor-investigator, Andrew Weeks MD MRCOG, University of Liverpool
- Investigators
- Abiola O Aiyenigba, PhD Student, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348865
- Sponsor's protocol ID
- 2121
- Acronym
- FeLiCiA
- Status last verified
- Jul 2019
- First submitted
- 16 Nov 2017
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Reduce Psychological Interventions Associated With Infertility in Nigeria.
- ClinicalTrials.gov ID
- NCT03348865
- Acronym / sponsor ID
- FeLiCiA / 2121
- Conditions
- Infertility/Sterility, Psychological Distress, Psychological Stress, Anxiety Disorders, Depressive Disorder
- Keywords
- Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Andrew Weeks MD MRCOGUniversity, hospital or other
- Collaborators
- University of Liverpool, University College Hospital, Ibadan, Nigeria
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fertility Life Counselling Aid (FeLiCiA) | Experimental | Behavioral: 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. |
| Control | No intervention | –Patients are to undergo treatment as usual. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fertility Life Counselling Aid (FeLiCiA)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. | Behavioural | Fertility Life Counselling Aid (FeLiCiA) |
Primary outcome
Measurement for absence of psychological morbidities post intervention
Time frame: 6 weeks
GHQ 12 score= less than 3 - No psychological morbidities
2 secondary outcomes
Explore patient perspective on benefits of intervention using qualitative methods, post intervention.
Time frame: 6 weeks
Measurement for sustained absence of psychological morbidities, 6months post intervention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abiola O Aiyenigba, PhD Student principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fertility Life Counselling Aid (FeLiCiA) in people with Infertility/Sterility and Psychological Distress, run by Andrew Weeks MD MRCOG at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement for absence of psychological morbidities post intervention (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.