NCT00855192

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.

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
20

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

2 active sites

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

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
9 months 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

March 18, 2010

Status Verified

March 1, 2009

Enrollment Period

1.2 years

First QC Date

March 2, 2009

Last Update Submit

March 17, 2010

Conditions

Keywords

anxietydepressionpregnancyantenatalprenatalmindfulness-based therapyinterpersonal therapysupport groups

Outcome Measures

Primary Outcomes (1)

  • Depression as measured by Edinburgh Postnatal Depression Scale and anxiety as measured by the State-Trait Anxiety Inventory and the Cambridge Worry Scale

    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.

Study Arms (2)

mindfulness-based therapy

EXPERIMENTAL

mindfulness-based meditation

Behavioral: mindful meditation

interpersonal therapy

EXPERIMENTAL

psycho-educational

Behavioral: interpersonal therapy

Interventions

interpersonal and psycho-educational

mindfulness-based therapy

psycho-educational

interpersonal therapy

Eligibility Criteria

Age16 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 28 weeks pregnant and English speaking

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saskatoon Community Village

Saskatoon, Saskatchewan, S7K 4A7, Canada

Location

University of Saskatchewan Department of Psychiatry

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Angela N Bowen, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 4, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 18, 2010

Record last verified: 2009-03

Locations