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

Specific Phobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02972112
• Other study ID #: TASMC-16-GA-0155-CTIL
• 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

• Specific Phobia

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