Antenatal Relaxation Group for Anxiety and Depression Management (ARG)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Royal University Hospital Foundation, Saskatoon, SK, Canada
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00855192
First received: March 2, 2009
Last updated: March 17, 2010
Last verified: March 2009
  Purpose

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 Intervention
Anxiety
Depression
Behavioral: mindful meditation
Behavioral: interpersonal therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mindfulness-based therapy
mindfulness-based meditation
Behavioral: mindful meditation
interpersonal and psycho-educational
Experimental: interpersonal therapy
psycho-educational
Behavioral: interpersonal therapy
psycho-educational

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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 15 to 28 weeks pregnant and English speaking

Exclusion Criteria:

  • Non-English speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855192

Locations
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
Investigators
Principal Investigator: Angela N Bowen, PhD University of Saskatchewan
  More Information

Additional Information:
No publications provided

Responsible Party: Angela Bowen, RN, PhD Assistant Professor, College of Nursing, College of Medicine, Department of Psychiatry, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT00855192     History of Changes
Other Study ID Numbers: Beh #07-10
Study First Received: March 2, 2009
Last Updated: March 17, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
anxiety
depression
pregnancy
antenatal
prenatal
mindfulness-based therapy
interpersonal therapy
support groups

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

ClinicalTrials.gov processed this record on April 15, 2014