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

NCT06640608 | Completed DMC

• 1 other identifier: 64
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

pregnant women; Fear of Childbirth; Self Efficacy; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Change Childbirth fears

  Pregnant women who receive an internet -based Cognitive Behavioral Therapy education report a significant change in a mean scores of fear of childbirth than those in a control group. Childbirth Attitude Questionnaire (CAQ) was used to assess childbirth fear. Scores range from 16 to 64, with higher scores indicating greater fear of childbirth. The CAQ categorizes scores into four levels: low (16-27), mild (28-39), moderate (40-51), and severe (52-64).

  6 weeks intervention

• Increase self-efficacy

  Pregnant women who receive an internet-based Cognitive Behavioral Therapy education report a significant change in mean scores of maternal self-efficacy than those in a control group. The Childbirth Self- Efficacy Inventory (CBSEI) was used including 32 items separating it into two distinct stages. The scale includes two parallel subscales: the outcome expectancy subscale measures the belief that certain behaviors will lead to specific outcomes, while the efficacy expectancy subscale assesses confidence in one's ability to perform these behaviors. Both subscales consist of the same 16 items related to coping behaviors during childbirth. Responses are rated on a Likert scale from 1 to 10, with higher scores reflecting greater self-efficacy in childbirth.

  6 weeks intervention

Study Arms (2)

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

EXPERIMENTAL

provide 6 consecutive an online modules

Behavioral: ICBT - Internet Based Cognitive Behavioral Therapy

Control group

NO INTERVENTION

Received routine antenatal care only

Interventions

ICBT - Internet Based Cognitive Behavioral Therapy BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

Governmental Clinics

Beheira, 22516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 40033245 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study participants and Outcome assessors are blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of psychiatric mental health nursing

Model Details: the study compare between intervention group (internet -based cognitive behavioral therapy therapy in addition to stander of care and the usual stander of care

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 15, 2024
• Study Start: March 5, 2023
• Primary Completion: December 31, 2023
• Study Completion: May 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

EG (1)