Specific PhobiaNCT02972112
Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
A study testing CBT in people with Specific Phobia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Specific Phobia
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Oct 2020
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hebrew speaking pregnant women week 32 + 0 to 37 + 0
- fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).
Who cannot join
- Women who suffer from a psychotic disorder, PTSD or suicidal ideation
- High risk pregnancies
- Alcoholism or drug abuse and dependence.
Trial locations and contacts
1 site in 1 country.
About this study
Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.
- Conditions
- Specific Phobia
- Being tested
- CBT, Sham
- Medical subject headings
- Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
novel cognitive behavioral protocol for the treatment of tokophobia
ShamOther
standard birth preparation sessions.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife. Receives: Behavioral: CBT |
| Control group | Sham comparator | will receive 2 sessions of a delivery preparation course (practice as usual). Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-Related Anxiety Questionnaire
a widely used instrument to assess and identify pregnancy-specific anxiety in women
Measured: In the end of second session of intervention- up to 4 weeks from screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2019 (estimated)
- Study completionOct 2020 (estimated)
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 Specific PhobiaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972112
- Sponsor's protocol ID
- TASMC-16-GA-0155-CTIL
- Status last verified
- Nov 2016
- First submitted
- 30 Oct 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
Publications
O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
PubMed 34231203
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT02972112
- Acronym / sponsor ID
- TASMC-16-GA-0155-CTIL
- Conditions
- Specific Phobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 23 Nov 2016 (estimated)
- 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.
Women in their 3rd trimester, represent a unique segment of the tokophobic population. In these cases help is needed within a very short and limited period of time. To date, no specific treatment targets this population in order to ameliorate the anxiety and to provide these women and their newborns with better obstetric and psychiatric outcomes. The present study investigates an accessible individual two session intervention conducted by midwives skilled in CBT (cognitive behavioral therapy) . This intervention is designed to enable stronger emotional regulation and increase of their capacity to accept unexpected changes during labor and feelings of control. The investigators expect this psychological adjustment to lead to a better course of delivery, less interventions including caesarian sections, and subjective birth experience.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Behavioral: CBTwill receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife. |
| Control group | Sham comparator | Other: Shamwill receive 2 sessions of a delivery preparation course (practice as usual). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hebrew speaking pregnant women week 32 + 0 to 37 + 0
- fulfilling the criteria for a specific phobia diagnosed by SCID (Structured Clinical Interview for the Diagnostic) in accordance with DSM-V (Diagnostic and Statistical Manual) and the Fear of Vaginal Delivery Questionnaire (FDQ).
Key exclusion criteria (3 listed)
- Women who suffer from a psychotic disorder, PTSD or suicidal ideation
- High risk pregnancies
- Alcoholism or drug abuse and dependence.
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 |
|---|---|---|
| CBTnovel cognitive behavioral protocol for the treatment of tokophobia | Behavioural | Study group |
| Shamstandard birth preparation sessions. | Other | Control group |
Primary outcome
Pregnancy-Related Anxiety Questionnaire
Time frame: In the end of second session of intervention- up to 4 weeks from screening
a widely used instrument to assess and identify pregnancy-specific anxiety in women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Derived from this study: PubMed 34231203O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
Related trials for Specific Phobia
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruiting
Effects of Dead Bug Exercises With and Without Diaphragmatic Breathing in Patients With Chronic Non-specific Low Back Pain.
Non-specific Chronic Low Back Pain
Not yet recruiting
Facing Fears From Home: Development, Feasibility and Maximization of FobiApp
Specific Phobia
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Recruiting
Metacognitive Therapy Compared to Cognitive-behavioral Therapy
Generalized Anxiety Disorder, Social Anxiety Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Specific Phobia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Nov 2016. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabi Aisenberg Romano, PhD (052-4262816, gabiar@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-Related Anxiety Questionnaire (time frame: In the end of second session of intervention- up to 4 weeks from screening). 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 NCT02972112, 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 23 Nov 2016.