Clinical trial NCT06640608: Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth
Official title: Efficacy of Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Fear of Childbirth
Self Efficacy
Cognitive Behavioral Therapy
Keywords: pregnant women
Fear of Childbirth
Self Efficacy
Cognitive Behavioral Therapy
Lead sponsor: Jouf University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study compare between intervention group (internet -based cognitive behavioral therapy therapy in addition to stander of care and the usual stander of care
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Change Childbirth fears
timeFrame: 6 weeks intervention
measure: Increase self-efficacy
timeFrame: 6 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beheira
country: Egypt
facility: Governmental Clinics
Study officials:
References: