Antenatal Relaxation Group for Anxiety and Depression Management (ARG)

March 17, 2010 updated by: University of Saskatchewan

Antenatal Depression Group Research Project: The Effectiveness of Mindfulness-based Relaxation and Interpersonal Therapy to Relieve Anxiety and Depression Symptoms in Pregnant Women.

Approximately 20% of pregnant women experience depression. Untreated depression during pregnancy is linked to decreased prenatal care, difficulties in the pregnancy, poorer outcomes for the baby, and developmental, language, and behaviour problems in the older child.

While medication can often offer relief, pregnant women suffering with depression are often reluctant to take medications that may affect the unborn baby. There is little research about the effectiveness of other treatments such as support groups.

The investigators project will provide relaxation groups for pregnant women with anxiety and depression. The group will provide a chance to get support from other pregnant women. Two health care specialists will provide information about anxiety and depression. They will also teach the skills for women to manage their symptoms. Women will be asked to complete a few questionnaires to evaluate their symptoms before, during, and after they join the group. They will also be asked to evaluate how the group met their needs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pregnant women between 15-28 weeks, who speak english are invited to join an 8 week group to relieve anxiety and depression.

We have collected sociodemographic data, as well as social support, life events.

Outcome measures are a decrease in anxiety and depression-as measured by the Edinburgh Postnatal Depression Scale, the Cambridge Worry Scale, and the STAI-Trait Scale.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 4A7
        • Saskatoon Community Village
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • University of Saskatchewan Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 15 to 28 weeks pregnant and English speaking

Exclusion Criteria:

  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mindfulness-based therapy
mindfulness-based meditation
Behavioral: mindful meditation
interpersonal and psycho-educational
Experimental: interpersonal therapy
psycho-educational
Behavioral: interpersonal therapy
psycho-educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression as measured by Edinburgh Postnatal Depression Scale and anxiety as measured by the State-Trait Anxiety Inventory and the Cambridge Worry Scale
Time Frame: Participants will be asked to complete the questionnaires before the group commences, at 4 weeks, at the end of the group, and 6 weeks postpartum.
Participants will be asked to complete the questionnaires before the group commences, at 4 weeks, at the end of the group, and 6 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Royal University Hospital Foundation, Saskatoon, SK, Canada

Investigators

  • Principal Investigator: Angela N Bowen, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2010

Last Update Submitted That Met QC Criteria

March 17, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beh #07-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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