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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02972112
Other study ID # TASMC-16-GA-0155-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 30, 2016
Last updated November 21, 2016
Start date November 2016
Est. completion date October 2020

Study information

Verified date November 2016
Source Tel-Aviv Sourasky Medical Center
Contact Gabi Aisenberg Romano, PhD
Phone 052-4262816
Email gabiar@tlvmc.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2020
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT
novel cognitive behavioral protocol for the treatment of tokophobia
Other:
Sham
standard birth preparation sessions.

Locations

Country Name City State
Israel The Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pregnancy-Related Anxiety Questionnaire a widely used instrument to assess and identify pregnancy-specific anxiety in women In the end of second session of intervention- up to 4 weeks from screening No
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