CClinicalTrials.gg
Status unknownNCT02972112Updated Nov 23, 2016

Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial

An interventional study of CBT and Sham in Specific Phobia, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Specific Phobia
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In context

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Hebrew speaking pregnant women week 32 + 0 to 37 + 0
  2. 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).

Exclusion criteria

Exclusion criteria:

  1. Women who suffer from a psychotic disorder, PTSD or suicidal ideation
  2. High risk pregnancies
  3. Alcoholism or drug abuse and dependence.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Study group

    will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.

    Behavioral: CBT

  • Sham comparator
    Control group

    will receive 2 sessions of a delivery preparation course (practice as usual).

    Other: Sham

Interventions

  • BehavioralCBT

    novel cognitive behavioral protocol for the treatment of tokophobia

  • OtherSham

    standard birth preparation sessions.

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What researchers measure

Primary outcomes

  1. Pregnancy-Related Anxiety Questionnaire

    a widely used instrument to assess and identify pregnancy-specific anxiety in women

    Time frame: In the end of second session of intervention- up to 4 weeks from screening

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Study locations

1 site
  • The Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02972112
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Nov 23, 2016
Start date
Nov 2016
Primary completion
Oct 2019 (estimated)
Completion
Oct 2020 (estimated)
Last update
Nov 23, 2016

Study contacts

Gabi Aisenberg Romano, PhD
Contact
gabiar@tlvmc.gov.il
052-4262816
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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