Fertility Life Counselling Aid- FeLiCiA

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.

Conditions

• Infertility/Sterility
• Psychological Distress
• Psychological Stress
• Anxiety Disorders
• Depressive Disorder

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• University College Hospital, Ibadan, Nigeria

  collaborator UNKNOWN

• Andrew Weeks MD MRCOG

  lead OTHER

Principal Investigators

• Abiola O Aiyenigba, PhD Student · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-20

Primary Completion

2018-03-27

Completion

2018-06-30

Countries

• Nigeria

Study Locations