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

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Specific Phobia

Treatments: Behavioral: CBT; Other: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02972112

TASMC-16-GA-0155-CTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Study group

Active Comparator group

Description:

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

Treatment:

Behavioral: CBT

Control group

Sham Comparator group

Description:

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

Treatment:

Other: Sham