NCT00801970

Brief Summary

The purpose of this study is twofold:

  • to understand the etiology and the essence of fear of childbirth
  • to examine the implications and efficiency of several forms of psychological therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 4, 2008

Status Verified

December 1, 2008

Enrollment Period

2.4 years

First QC Date

December 3, 2008

Last Update Submit

December 3, 2008

Conditions

Phobias

Keywords

Fear of childbirthTokophobiaAnxietyLaborPregnancyCognitive-behavioralPsychoanalysisGroup Therapyetiology

Outcome Measures

Primary Outcomes (1)

  • Tokophobia existing and new measures (e.g. Pregnancy anxiety scale, Levin, 1991; Tokophobia subjective scale)

    Pre-treatment, Mid treatment, End of treatment

Secondary Outcomes (1)

  • For pregnant subjects - labor preference, duration and pain medication assessment.

    post-labor

Study Arms (4)

1 - Pregnant - Tokophobic

EXPERIMENTAL

Psychoanalysis treatment.

Behavioral: Psychological Treatment

2 - Pregnant - Tokophobic

EXPERIMENTAL

Cognitive-Behavioral treatment.

Behavioral: Psychological Treatment

3 - Non-pregnant - Tokophobic

EXPERIMENTAL

Group Therapy

Behavioral: Group Therapy

4 - Control

NO INTERVENTION

Pregnant and non-pregnant non-tokophobic women will answer questionnaires. Won't receive therapy.

Interventions

Psychological TreatmentBEHAVIORAL

15 weekly therapy sessions.

Also known as: Psychotherapy, Psychodynamic therapy, Cognitive Behavioral Therapy, CBT
1 - Pregnant - Tokophobic2 - Pregnant - Tokophobic
Group TherapyBEHAVIORAL

3 months of weekly group therapy sessions.

Also known as: Psychotherapy, Group Psychotherapy
3 - Non-pregnant - Tokophobic

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • subjective diagnosis of tokophobia

You may not qualify if:

  • currently undergoing psychological therapy
  • Major Depression
  • Acute Anxiety
  • Psychosis
  • Bipolar Disorder
  • Suicidal
  • Substance abuse
  • Non-compliant personality disorder
  • Health problems during pregnancy that affect perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry Outpatient Clinic - Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (9)

  • Areskog B, Uddenberg N, Kjessler B. Fear of childbirth in late pregnancy. Gynecol Obstet Invest. 1981;12(5):262-6. doi: 10.1159/000299611.

    PMID: 7262639BACKGROUND

  • Eriksson C, Jansson L, Hamberg K. Women's experiences of intense fear related to childbirth investigated in a Swedish qualitative study. Midwifery. 2006 Sep;22(3):240-8. doi: 10.1016/j.midw.2005.10.002. Epub 2006 Apr 17.

    PMID: 16603282BACKGROUND

  • Hofberg K, Brockington I. Tokophobia: an unreasoning dread of childbirth. A series of 26 cases. Br J Psychiatry. 2000 Jan;176:83-5. doi: 10.1192/bjp.176.1.83.

    PMID: 10789333BACKGROUND

  • Hofberg K, Ward MR. Fear of childbirth, tocophobia, and mental health in mothers: the obstetric-psychiatric interface. Clin Obstet Gynecol. 2004 Sep;47(3):527-34. doi: 10.1097/01.grf.0000132527.62504.ca. No abstract available.

    PMID: 15326415BACKGROUND

  • Alehagen S, Wijma K, Wijma B. Fear during labor. Acta Obstet Gynecol Scand. 2001 Apr;80(4):315-20. doi: 10.1034/j.1600-0412.2001.080004315.x.

    PMID: 11264605BACKGROUND

  • Eriksson C, Westman G, Hamberg K. Experiential factors associated with childbirth-related fear in Swedish women and men: a population based study. J Psychosom Obstet Gynaecol. 2005 Mar;26(1):63-72. doi: 10.1080/01674820400023275.

    PMID: 15962723BACKGROUND

  • Johnson R, Slade P. Does fear of childbirth during pregnancy predict emergency caesarean section? BJOG. 2002 Nov;109(11):1213-21. doi: 10.1046/j.1471-0528.2002.01351.x.

    PMID: 12452457BACKGROUND

  • Olde E, van der Hart O, Kleber R, van Son M. Posttraumatic stress following childbirth: a review. Clin Psychol Rev. 2006 Jan;26(1):1-16. doi: 10.1016/j.cpr.2005.07.002. Epub 2005 Sep 19.

    PMID: 16176853BACKGROUND

  • Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8.

    PMID: 12694113BACKGROUND

MeSH Terms

Conditions

Phobic DisordersAnxiety Disorders

Interventions

PsychotherapyCognitive Behavioral TherapyPsychotherapy, Group

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesBehavior TherapySocioenvironmental Therapy

Study Officials

  • Miki Bloch, M.D

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shulamit Ben-Itzhak, PhD

CONTACT

972-3-697-4567shulamit@tasmc.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 3, 2008

First Posted

December 4, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

January 1, 2011

Last Updated

December 4, 2008

Record last verified: 2008-12

Locations

IL(1)