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

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ClinicalTrials.gov Identifier: NCT02972112
Recruitment Status : Not yet recruiting
First Posted : November 23, 2016
Last Update Posted : November 23, 2016
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Specific Phobia Behavioral: CBT Other: Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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
novel cognitive behavioral protocol for the treatment of tokophobia

Sham Comparator: Control group
will receive 2 sessions of a delivery preparation course (practice as usual).
Other: Sham
standard birth preparation sessions.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972112


Contacts
Contact: Gabi Aisenberg Romano, PhD 052-4262816 gabiar@tlvmc.gov.il

Locations
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02972112     History of Changes
Other Study ID Numbers: TASMC-16-GA-0155-CTIL
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: November 23, 2016
Last Verified: November 2016