Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 23, 2016
November 1, 2016
2.9 years
October 30, 2016
November 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Study group
ACTIVE COMPARATORwill receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.
Control group
SHAM COMPARATORwill receive 2 sessions of a delivery preparation course (practice as usual).
Interventions
Eligibility Criteria
You may qualify if:
- Hebrew speaking pregnant women week 32 + 0 to 37 + 0
- 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).
You may not qualify if:
- Women who suffer from a psychotic disorder, PTSD or suicidal ideation
- High risk pregnancies
- Alcoholism or drug abuse and dependence.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Related Publications (1)
O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
PMID: 34231203DERIVED
MeSH Terms
Conditions
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2016
First Posted
November 23, 2016
Study Start
November 1, 2016
Primary Completion
October 1, 2019
Study Completion
October 1, 2020
Last Updated
November 23, 2016
Record last verified: 2016-11