Pregnant WomenNCT06640608
Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth
A study testing ICBT - Internet Based Cognitive Behavioral Therapy in people with Pregnant Women and Fear of Childbirth, run by Jouf University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnant Women, Fear of Childbirth, Self Efficacy
- What is being tested?
- ICBT - Internet Based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Mar 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth: A Randomized Controlled Trial
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
Read the 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
- Being tested
- ICBT - Internet Based Cognitive Behavioral Therapy
- Keywords
- pregnant women, Fear of Childbirth, Self Efficacy, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBT - Internet Based Cognitive Behavioral TherapyBehavioural
The study (intervention) group received 6 consecutive sessions utilizing ICBT techniques to overcome Fear of childbirth
| Study group | Role | What they receive |
|---|---|---|
| intervention group ( received ICBT in addition to routine antenatal care) | Experimental | provide 6 consecutive an online modules Receives: Behavioral: ICBT - Internet Based Cognitive Behavioral Therapy |
| Control group | No intervention | Received routine antenatal care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 6 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Mar 2023
- Primary completion31 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jouf University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Mahrous AbdelAziz, Jouf University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640608
- Sponsor's protocol ID
- 64
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40033245
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Internet- Based Cognitive Behavioral Therapy Among Women With Fear of Childbirth: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06640608
- Acronym / sponsor ID
- 64
- Keywords
- pregnant women, Fear of Childbirth, Self Efficacy, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jouf UniversityUniversity, hospital or other
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| intervention group ( received ICBT in addition to routine antenatal care) | Experimental | Behavioral: ICBT - Internet Based Cognitive Behavioral Therapyprovide 6 consecutive an online modules |
| Control group | No intervention | –Received routine antenatal care only |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICBT - Internet Based Cognitive Behavioral TherapyThe study (intervention) group received 6 consecutive sessions utilizing ICBT techniques to overcome Fear of childbirth | Behavioural | intervention group ( received ICBT in addition to routine antenatal care) |
Primary outcome
Change Childbirth fears
Time frame: 6 weeks intervention
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).
Increase self-efficacy
Time frame: 6 weeks intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 40033245Abdelaziz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICBT - Internet Based Cognitive Behavioral Therapy in people with Pregnant Women and Fear of Childbirth, run by Jouf University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Childbirth fears (time frame: 6 weeks intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.