Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth

NCT ID: NCT06640608

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-05
• Study Completion Date: 2024-05-30

Brief Summary

Fear of Birth is common in pregnant women and associated with physiological and psychological consequences. Fear is mostly associated with fear of losing control, fear for the baby's life or health or own life threatening events .

Cognitive Behaviour Therapy (CBT) is the treatment of choice for most anxiety disorders and for women with mental health problems during pregnancy and postpartum.. It has been suggested for perinatal women as with Fear of Birth. Internet-based cognitive behavioural therapy have shown it is efficiency as treatment for anxiety and depression as traditional face-to-face CBT in managing emotional problems for women

Detailed Description

Fear of Birth is common in pregnant women , the current study aims to examine the efficacy of an Internet-based Cognitive behavioral therapy compared to standard of care for women with fear of child birth( moderate /severe).

The study comparing internet -based Cognitive Behavioral therapy in addition to routine stander of antenatal care (interventional group) with others who are receiving stander of care alone( control group). The study is the second phase of the study project named "Prevalence of childbirth fear and associated factors among pregnant women.

based on inclusion and exclusion criteria, the total participants who have moderate and severe level of child birth fear is 169 pregnant women . The final sample eligible is 96 participants . Those will assign randomly to either interventional / control group

the interventional group will receive internet -based cognitive behavioural therapy program accompanied with stander of care providing at antenatal clinics . through whats app group the researchers will provide the program contents

Conditions

Pregnant Women; Fear of Childbirth; Self Efficacy; Cognitive Behavioral Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

intervention group ( received ICBT in addition to routine antenatal care)

provide 6 consecutive an online modules

Group Type: EXPERIMENTAL

ICBT - Internet Based Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

The study (intervention) group received 6 consecutive sessions utilizing ICBT techniques to overcome Fear of childbirth

Control group

Received routine antenatal care only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICBT - Internet Based Cognitive Behavioral Therapy

The study (intervention) group received 6 consecutive sessions utilizing ICBT techniques to overcome Fear of childbirth

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• accepting and willing to engage in an ICBT program
• participants experienced a fear of childbirth score ranging from 40 to 64 based on the Childbirth Attitude Questionnaire (CAQ)
• Aged between 18 and 35 years
• Gestational age of at least 28 weeks (determined by an accurate last menstrual period)
• singleton pregnancy
• (Capability to read, write, and understand the essence of the provided questionnaires
• have a smartphone with internet access
• had not participated in any antenatal intervention or education.

Exclusion Criteria

• women diagnosed with pathological anxiety or depression
• Pregnancies associated with serious health issues (e.g., hypertension, infections, diabetes, obesity, etc.)
• A recent history of pregnancy complications
• women not respond for at least two modules of intervention program
• A recent history of miscarriage or neonatal loss
• A history of infertility
• Lack of access to the internet.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jouf University

OTHER

Sponsor Role: lead

Responsible Party

Enas Mahrous AbdelAziz

Assistant professor of psychiatric mental health nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Governmental Clinics

Beheira, , Egypt

Countries

Egypt

References

Abdelaziz EM, Alshammari AM, Elsharkawy NB, Oraby FA, Ramadan OME. Digital intervention for tokophobia: a randomized controlled trial of internet-based cognitive behavioral therapy on fear of childbirth and self-efficacy among Egyptian pregnant women. BMC Pregnancy Childbirth. 2025 Mar 3;25(1):233. doi: 10.1186/s12884-025-07341-5.

Reference Type: DERIVED

PMID: 40033245 (View on PubMed)

Other Identifiers

64

Identifier Type: -

Identifier Source: org_study_id