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Group Cognitive Behavioural Therapy (CBT) For Perinatal Anxiety

Primary Purpose

Perinatal Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)
No treatment (waitlist control)
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult over the age of 18 years living in the province of Manitoba, Canada.
  • Must be pregnant or within 12 months postpartum.
  • Women must also meet criteria for at least one anxiety disorder or related disorder (i.e., generalized anxiety disorder, social anxiety disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, or posttraumatic stress disorder).

Exclusion Criteria:

  • Primary perinatal depression
  • Active suicidality and/or homicidality
  • Active psychosis, manic, or a substance use disorder that would interfere with participation in treatment.
  • Women also must not be receiving concurrent psychotherapy
  • If on medication, must not have made any medication changes in the 6 weeks prior to beginning participation in our study.

Sites / Locations

  • St. Boniface Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group CBT for Perinatal Anxiety

Waitlist Control

Arm Description

Using cognitive-behavioural therapy principles, this group therapy is intended to treat perinatal anxiety.

This is a control condition in which patients are randomly assigned to the waitlist control condition before receiving the treatment.

Outcomes

Primary Outcome Measures

Change in scores on the Perceived Stress Scale
This is a 10-item self-report measure that assesses the extent to which one's life is appraised as stressful. Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Changes in scores on the Perinatal Anxiety Screening Scale
This is a 31-item self-report measure assessing symptoms of anxiety during the perinatal period. Scores on this measure can range from 0 to 93, with higher scores indicating higher levels of anxiety. It will be used in the current investigation to examine changes in anxiety symptoms across time.

Secondary Outcome Measures

Change in scores on the The Edinburgh Postnatal Depression Scale
10-item self-report measure assessing symptoms of postnatal depression on a 0 to 3 scale. Scores can range from 0 to 30, with higher scores indicating higher levels of postnatal depression.
Change in scores on the Maternal Antenatal Attachment Scale
This is a 19-item self-report measure that assesses maternal attachment towards her unborn baby in the antenatal period. This measure will be administered to women who are participating in the study during the prenatal period. Scores range from 19 to 95, with higher scores indicating a higher level of attachment to the fetus.
Change in scores on the Maternal Efficacy Questionnaire
This is a 10-item self-report measure that assesses a mother's perception of her own parenting competence. Scores on this measure range from 10 to 40, with higher scores indicating higher levels of self-efficacy.
Change in scores on the Maternal Postnatal Attachment Scale
This is a 19-item self-report measure that assesses maternal attachment towards her infant during the postnatal period. This measure will be administered to women who are participating in the study during the postpartum period. Higher scores indicate higher levels of attachment to baby.
Post-Delivery Perceived Stress Inventory
This is a 29-item self-report measure of the degree of stress experienced as a result of the birth experience specifically. The PPSI will be administered at the intake assessment to postpartum women. Scores range from 0 to 116, with higher scores indicating higher levels of perceived stress.
The Treatment Acceptability/Adherence Scale
This is a self-report measure of treatment acceptability. It will be administered at treatment outset to determine the perceived acceptability of the treatment to participants. Scores range from 7 to 70, with higher scores indicating higher levels of treatment acceptability.
The Treatment Satisfaction Measure
This measure was developed for use in our clinic to evaluate patient impressions of treatment. Four items regarding the helpfulness of the sessions, the group aspect, the workbook, and the focus on perinatal issues are rated on a 5-point scale (i.e., from "very helpful" to "not at all helpful"). Two additional yes/no questions are included, regarding whether participants would recommend the program to other perinatal women and whether they themselves would participate in the group again if needed. Two final open-ended questions are included regarding what patients liked about group, and any suggestions they would have for changes to future groups.
Change in scores on the The Hamilton Anxiety Rating Scale
A 14-item clinician-administered interview scale used to assess the severity of anxiety symptoms. It will be used in the present study to examine changes in anxiety symptoms from pre- to post-treatment. Scores can range from 0 to 30, with higher scores indicating greater anxiety severity.
The Homework Checklist
A list of all homework assignments from each session. Participants will complete the list at each session regarding the previous week's homework assignments, whether they worked on each element, for how long, and any comments they might have.
The Treatment Protocol Adherence Checklist
A checklist copy of the group leader's guide to each session, with a spot to check off if each element was covered, and open-ended questions regarding deviations from the protocol; and other session occurrences of note.
The Coronavirus Stressor Survey
A 10-item survey that asks about the impact of the coronavirus pandemic on the lives of participants.

Full Information

First Posted
September 22, 2020
Last Updated
July 28, 2023
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04581681
Brief Title
Group Cognitive Behavioural Therapy (CBT) For Perinatal Anxiety
Official Title
Group Cognitive Behaviour Therapy for Perinatal Anxiety: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Our previous pilot study (N = 40) suggested that group Cognitive Behaviour Therapy for perinatal anxiety (CBT-PA) significantly reduces symptoms of anxiety and depression from pre- to post- intervention. CBT-PA is based on the general principles of CBT but specific themes and examples are geared towards pregnancy and postpartum periods. The 6-week treatment protocol addresses: (1) understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. This intervention and all assessment interviews will be conducted via a hospital-approved video-conferencing platform. All assessment questionnaires will be completed on SurveyGizmo. The objectives of the present study are: (1) to replicate these findings of the pilot study in a larger sample (N = 58) in a randomized controlled trial (RCT), (2) compare the effectiveness of CBT-PA to a control treatment (waitlist control), (3) evaluate the durability of treatment gains at 1-month and 3-months after the conclusion of treatment, (4) evaluate patient preferences in terms of the relevance and the acceptability of the CBT-PA protocol, (5) examine whether the degree of childbirth stress impacts patient response to CBT-PA to inform future refinements to the treatment, and (6) determine whether CBT-PA improves maternal efficacy and attachment with baby. This research is being conducted because many women suffer from perinatal anxiety and have difficulty accessing services in a timely manner. It is the hope that the findings of this study will have clinical significance in terms of providing additional support for CBT as an effective treatment for perinatal anxiety. It is the hope that this treatment will have mental and physical health benefits for the mothers directly, as well as mental and physical health benefits to their fetuses and infants.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group CBT for Perinatal Anxiety
Arm Type
Experimental
Arm Description
Using cognitive-behavioural therapy principles, this group therapy is intended to treat perinatal anxiety.
Arm Title
Waitlist Control
Arm Type
Active Comparator
Arm Description
This is a control condition in which patients are randomly assigned to the waitlist control condition before receiving the treatment.
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)
Intervention Description
The 6-session group CBT intervention for perinatal anxiety has been formalized with session guides for the facilitators and a workbook, "Overcoming Anxiety in Pregnancy and Postpartum" (Furer & Reynolds, 2015), developed by members of our Anxiety Disorders Clinic. There are 6 core modules covered over the 6 treatment sessions, including: (1) Understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. Content is based on general principles of CBT for anxiety but specific themes and examples are geared towards the pregnancy and postpartum periods. Distorted cognitions are also explored, with an additional focus on beliefs about motherhood and perfectionism. Due to the COVID-19 pandemic, the intervention will be conducted via a hospital-approved video-conferencing platform.
Intervention Type
Other
Intervention Name(s)
No treatment (waitlist control)
Intervention Description
Patients in this condition are randomly assigned to a waitlist control condition before receiving treatment.
Primary Outcome Measure Information:
Title
Change in scores on the Perceived Stress Scale
Description
This is a 10-item self-report measure that assesses the extent to which one's life is appraised as stressful. Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.
Time Frame
Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks
Title
Changes in scores on the Perinatal Anxiety Screening Scale
Description
This is a 31-item self-report measure assessing symptoms of anxiety during the perinatal period. Scores on this measure can range from 0 to 93, with higher scores indicating higher levels of anxiety. It will be used in the current investigation to examine changes in anxiety symptoms across time.
Time Frame
Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment, up to 6 weeks
Secondary Outcome Measure Information:
Title
Change in scores on the The Edinburgh Postnatal Depression Scale
Description
10-item self-report measure assessing symptoms of postnatal depression on a 0 to 3 scale. Scores can range from 0 to 30, with higher scores indicating higher levels of postnatal depression.
Time Frame
Pre-treatment (intake assessment), immediately post-treatment; 1-month follow-up; 3-month follow-up; and weekly during treatment, up to 6 weeks
Title
Change in scores on the Maternal Antenatal Attachment Scale
Description
This is a 19-item self-report measure that assesses maternal attachment towards her unborn baby in the antenatal period. This measure will be administered to women who are participating in the study during the prenatal period. Scores range from 19 to 95, with higher scores indicating a higher level of attachment to the fetus.
Time Frame
Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
Title
Change in scores on the Maternal Efficacy Questionnaire
Description
This is a 10-item self-report measure that assesses a mother's perception of her own parenting competence. Scores on this measure range from 10 to 40, with higher scores indicating higher levels of self-efficacy.
Time Frame
Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
Title
Change in scores on the Maternal Postnatal Attachment Scale
Description
This is a 19-item self-report measure that assesses maternal attachment towards her infant during the postnatal period. This measure will be administered to women who are participating in the study during the postpartum period. Higher scores indicate higher levels of attachment to baby.
Time Frame
Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
Title
Post-Delivery Perceived Stress Inventory
Description
This is a 29-item self-report measure of the degree of stress experienced as a result of the birth experience specifically. The PPSI will be administered at the intake assessment to postpartum women. Scores range from 0 to 116, with higher scores indicating higher levels of perceived stress.
Time Frame
Pre-treatment (intake assessment)
Title
The Treatment Acceptability/Adherence Scale
Description
This is a self-report measure of treatment acceptability. It will be administered at treatment outset to determine the perceived acceptability of the treatment to participants. Scores range from 7 to 70, with higher scores indicating higher levels of treatment acceptability.
Time Frame
Pre-treatment (at the outset of treatment)
Title
The Treatment Satisfaction Measure
Description
This measure was developed for use in our clinic to evaluate patient impressions of treatment. Four items regarding the helpfulness of the sessions, the group aspect, the workbook, and the focus on perinatal issues are rated on a 5-point scale (i.e., from "very helpful" to "not at all helpful"). Two additional yes/no questions are included, regarding whether participants would recommend the program to other perinatal women and whether they themselves would participate in the group again if needed. Two final open-ended questions are included regarding what patients liked about group, and any suggestions they would have for changes to future groups.
Time Frame
Immediately post-treatment
Title
Change in scores on the The Hamilton Anxiety Rating Scale
Description
A 14-item clinician-administered interview scale used to assess the severity of anxiety symptoms. It will be used in the present study to examine changes in anxiety symptoms from pre- to post-treatment. Scores can range from 0 to 30, with higher scores indicating greater anxiety severity.
Time Frame
Pre-treatment; immediately post-treatment; 1-month post-treatment; 3-months post-treatment
Title
The Homework Checklist
Description
A list of all homework assignments from each session. Participants will complete the list at each session regarding the previous week's homework assignments, whether they worked on each element, for how long, and any comments they might have.
Time Frame
From group treatment session two, up to five weeks.
Title
The Treatment Protocol Adherence Checklist
Description
A checklist copy of the group leader's guide to each session, with a spot to check off if each element was covered, and open-ended questions regarding deviations from the protocol; and other session occurrences of note.
Time Frame
Completed by group leaders weekly, up to 6 weeks.
Title
The Coronavirus Stressor Survey
Description
A 10-item survey that asks about the impact of the coronavirus pandemic on the lives of participants.
Time Frame
Pre-treatment (intake assessment)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult over the age of 18 years living in the province of Manitoba, Canada. Must be pregnant or within 12 months postpartum. Women must also meet criteria for at least one anxiety disorder or related disorder (i.e., generalized anxiety disorder, social anxiety disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, or posttraumatic stress disorder). Exclusion Criteria: Primary perinatal depression Active suicidality and/or homicidality Active psychosis, manic, or a substance use disorder that would interfere with participation in treatment. Women also must not be receiving concurrent psychotherapy If on medication, must not have made any medication changes in the 6 weeks prior to beginning participation in our study.
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H2A6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Group Cognitive Behavioural Therapy (CBT) For Perinatal Anxiety

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