Antenatal Relaxation Group for Anxiety and Depression Management (ARG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00855192
Recruitment Status : Unknown
Verified March 2009 by University of Saskatchewan.
Recruitment status was:  Enrolling by invitation
First Posted : March 4, 2009
Last Update Posted : March 18, 2010
Royal University Hospital Foundation, Saskatoon, SK, Canada
Information provided by:
University of Saskatchewan

Brief Summary:

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.

Condition or disease Intervention/treatment
Anxiety Depression Behavioral: mindful meditation Behavioral: interpersonal therapy

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antenatal Depression Group Research Project: The Effectiveness of Mindfulness-based Relaxation and Interpersonal Therapy to Relieve Anxiety and Depression Symptoms in Pregnant Women.
Study Start Date : October 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 15 to 28 weeks pregnant and English speaking

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00855192

Canada, Saskatchewan
Saskatoon Community Village
Saskatoon, Saskatchewan, Canada, S7K 4A7
University of Saskatchewan Department of Psychiatry
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation, Saskatoon, SK, Canada
Principal Investigator: Angela N Bowen, PhD University of Saskatchewan

Additional Information:
Responsible Party: Angela Bowen, RN, PhD Assistant Professor, College of Nursing, College of Medicine, Department of Psychiatry, University of Saskatchewan Identifier: NCT00855192     History of Changes
Other Study ID Numbers: Beh #07-10
First Posted: March 4, 2009    Key Record Dates
Last Update Posted: March 18, 2010
Last Verified: March 2009

Keywords provided by University of Saskatchewan:
mindfulness-based therapy
interpersonal therapy
support groups

Additional relevant MeSH terms:
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders