NCT00307320

Brief Summary

Researchers at UVa Health System are interested in how women experience and deal with stress during pregnancy. Participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. Researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 30, 2009

Status Verified

August 1, 2008

Enrollment Period

3.8 years

First QC Date

March 24, 2006

Last Update Submit

December 29, 2009

Conditions

Stress

Keywords

pregnancystressanxiety

Study Arms (2)

1

NO INTERVENTION

2

EXPERIMENTAL

Relaxation techniques

Behavioral: Relaxation Training

Interventions

Relaxation TrainingBEHAVIORAL

Relaxation techniques training

2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • beginning of the 2nd trimester of pregnancy
  • feel stressed or overwhelmed
  • do not yet have any children

You may not qualify if:

  • more than 1 miscarriage
  • currently receiving medication for anxiety or depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia, Department of Psychology

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andrea Chambers, MA

    University of Virginia / University of Arizona

    STUDY DIRECTOR

  • Susan Kirk, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 27, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 30, 2009

Record last verified: 2008-08

Locations

US(1)