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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02972112

Enrollment

100

Registered

2016-11-23

Start date

2016-11-30

Completion date

2020-10-31

Last updated

2016-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specific Phobia

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.

Interventions

BEHAVIORALCBT

novel cognitive behavioral protocol for the treatment of tokophobia

OTHERSham

standard birth preparation sessions.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactGabi Aisenberg Romano, PhD

gabiar@tlvmc.gov.il052-4262816

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026