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

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02972112
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Specific Phobia	Behavioral: CBT; Other: Sham	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Ultrashort Cognitive Behavioral Intervention for Tokophobia- A Prospective Randomized Single Blinded Controlled Trial
• Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Oct 1, 2019
• Anticipated Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study group will receive 2 sessions of 90 minutes each of a cognitive behavioral protocol for the treatment of Tokophobia administered by a CBT trained midwife.	Behavioral: CBT; novel cognitive behavioral protocol for the treatment of tokophobia
Sham Comparator: Control group will receive 2 sessions of a delivery preparation course (practice as usual).	Other: Sham; standard birth preparation sessions.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Tel Aviv Sourasky Medical Center	Tel Aviv		Israel

Sponsors and Collaborators

• Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT02972112
• Other Study ID Numbers: TASMC-16-GA-0155-CTIL
• First Posted: Nov 23, 2016
• Last Update Posted: Nov 23, 2016
• Last Verified: Nov 1, 2016

Study Results

No Results Posted as of Nov 23, 2016