Fertility Life Counselling Aid- FeLiCiA
Condition: Infertility/Sterility; Psychological Distress; Psychological Stress; Anxiety Disorders; Depressive Disorder
MeSH terms: Infertility; Depressive Disorder; Anxiety Disorders; Stress, Psychological
Study type: Interventional

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.
    

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.
    

Intervention name(s): Fertility Life Counselling Aid (FeLiCiA)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cognitive Behavioural Therapy