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

Not Applicable

• Conditions: Specific Phobia
• Interventions: Other: Sham; Behavioral: CBT

• Registration Number: NCT02972112
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-30
• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted QC: 2016-11-21
• Last Update Submitted: 2016-11-21
• Study First Posted: 2016-11-23
• Last Update Posted: 2016-11-23
• Primary Completion: 2019-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham	will receive 2 sessions of a delivery preparation course (practice as usual).
Study group	CBT	will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.

Primary Outcome Measures

Name	Time	Method
Pregnancy-Related Anxiety Questionnaire	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

Trial Locations

Locations (1)

The Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel