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Antenatal Relaxation Group for Anxiety and Depression Management (ARG)

Primary Purpose

Anxiety, Depression

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

mindful meditation

interpersonal therapy

About this trial

This is an interventional treatment trial for Anxiety focused on measuring anxiety, depression, pregnancy, antenatal, prenatal, mindfulness-based therapy, interpersonal therapy, support groups

Eligibility Criteria

16 Years - 60 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

15 to 28 weeks pregnant and English speaking

Exclusion Criteria:

Non-English speaking

Sites / Locations

Saskatoon Community Village
University of Saskatchewan Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

mindfulness-based therapy

interpersonal therapy

Arm Description

mindfulness-based meditation

psycho-educational

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00855192

First Posted

March 2, 2009

Last Updated

March 17, 2010

Sponsor

University of Saskatchewan

Collaborators

Royal University Hospital Foundation, Saskatoon, SK, Canada

1. Study Identification

Unique Protocol Identification Number

NCT00855192

Brief Title

Antenatal Relaxation Group for Anxiety and Depression Management

Acronym

ARG

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 Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Saskatchewan

Collaborators

Royal University Hospital Foundation, Saskatoon, SK, Canada

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression

Keywords

anxiety, depression, pregnancy, antenatal, prenatal, mindfulness-based therapy, interpersonal therapy, support groups

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mindfulness-based therapy

Arm Type

Experimental

Arm Description

mindfulness-based meditation

Arm Title

interpersonal therapy

Arm Type

Experimental

Arm Description

psycho-educational

Intervention Type

Behavioral

Intervention Name(s)

mindful meditation

Intervention Description

interpersonal and psycho-educational

Intervention Type

Behavioral

Intervention Name(s)

interpersonal therapy

Intervention Description

psycho-educational

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 15 to 28 weeks pregnant and English speaking Exclusion Criteria: Non-English speaking

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela N Bowen, PhD

Organizational Affiliation

University of Saskatchewan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saskatoon Community Village

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 4A7

Country

Canada

Facility Name

University of Saskatchewan Department of Psychiatry

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 0W8

Country

Canada

12. IPD Sharing Statement

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Antenatal Relaxation Group for Anxiety and Depression Management

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