Fertility Life Counselling Aid- FeLiCiA

NCT03348865 | Completed DMC

• 1 other identifier: 2121
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Research Objectives:

1. 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. 2.To explore and understand patient perspectives on the benefits of the FeLiCiA counselling in addition to usual clinical care.
3. 3.Sustained GHQ12 score less than 3
4. 4.Patient perspectives on benefits and effectiveness of intervention, and patient empowerment post intervention.

Conditions

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

Keywords

Cognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

• Measurement for absence of psychological morbidities post intervention

  GHQ 12 score= less than 3 - No psychological morbidities

  6 weeks

Secondary Outcomes (2)

• Explore patient perspective on benefits of intervention using qualitative methods, post intervention.

  6 weeks

• Measurement for sustained absence of psychological morbidities, 6months post intervention

  6 months

Study Arms (2)

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.

Behavioral: Fertility Life Counselling Aid (FeLiCiA)

Control

NO INTERVENTION

Patients are to undergo treatment as usual.

Interventions

Fertility Life Counselling Aid (FeLiCiA) BEHAVIORAL

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.

Fertility Life Counselling Aid (FeLiCiA)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew Weeks MD MRCOG: lead
• University of Liverpool: collaborator
• University College Hospital, Ibadan, Nigeria: collaborator

Study Sites (1)

University College Hospital, Ibadan

Ibadan, Oyo State, Nigeria

Location

MeSH Terms

Conditions

Infertility; Stress, Psychological; Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Mood Disorders

Study Officials

• Abiola O Aiyenigba, PhD Student

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of International Maternal Health

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: November 20, 2017
• Primary Completion: March 27, 2018
• Study Completion: June 30, 2018
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

NG (1)