Perinatal AnxietyNCT04581681
Group Cognitive Behavioural Therapy (CBT) For Perinatal Anxiety
A study testing Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA) in people with Perinatal Anxiety, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Anxiety
- What is being tested?
- Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group Cognitive Behaviour Therapy for Perinatal Anxiety: A Randomized Controlled Trial
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.
- Conditions
- Perinatal Anxiety
- Being tested
- Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA), No treatment (waitlist control)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)Behavioural
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.
No treatment (waitlist control)Other
Patients in this condition are randomly assigned to a waitlist control condition before receiving treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group CBT for Perinatal Anxiety | Experimental | Using cognitive-behavioural therapy principles, this group therapy is intended to treat perinatal anxiety. Receives: Behavioral: Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA) |
| Waitlist Control | Active comparator | This is a control condition in which patients are randomly assigned to the waitlist control condition before receiving the treatment. Receives: Other: No treatment (waitlist control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks
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.
Measured: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment, up to 6 weeks
Secondary outcomes (11)
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.
Measured: Pre-treatment (intake assessment), immediately post-treatment; 1-month follow-up; 3-month follow-up; and weekly during treatment, up to 6 weeks
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.
Measured: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
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.
Measured: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
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.
Measured: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
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.
Measured: Pre-treatment (intake assessment)
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.
Measured: Pre-treatment (at the outset of treatment)
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.
Measured: Immediately post-treatment
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.
Measured: Pre-treatment; immediately post-treatment; 1-month post-treatment; 3-months post-treatment
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.
Measured: From group treatment session two, up to five weeks.
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.
Measured: Completed by group leaders weekly, up to 6 weeks.
The Coronavirus Stressor Survey
A 10-item survey that asks about the impact of the coronavirus pandemic on the lives of participants.
Measured: Pre-treatment (intake assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start2 Dec 2020
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal AnxietyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gillian Alcolado, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581681
- Sponsor's protocol ID
- H2020:095
- Status last verified
- May 2026
- First submitted
- 22 Sep 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Behaviour Therapy for Perinatal Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04581681
- Acronym / sponsor ID
- H2020:095
- Conditions
- Perinatal Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CBT for Perinatal Anxiety | Experimental | Behavioral: Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)Using cognitive-behavioural therapy principles, this group therapy is intended to treat perinatal anxiety. |
| Waitlist Control | Active comparator | Other: No treatment (waitlist control)This is a control condition in which patients are randomly assigned to the waitlist control condition before receiving the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)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. | Behavioural | Group CBT for Perinatal Anxiety |
| No treatment (waitlist control)Patients in this condition are randomly assigned to a waitlist control condition before receiving treatment. | Other | Waitlist Control |
Primary outcome
Change in scores on the Perceived Stress Scale
Time frame: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks
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
Time frame: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment, up to 6 weeks
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.
11 secondary outcomes
Change in scores on the The Edinburgh Postnatal Depression Scale
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
Change in scores on the Maternal Antenatal Attachment Scale
Time frame: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
Change in scores on the Maternal Efficacy Questionnaire
Time frame: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
Change in scores on the Maternal Postnatal Attachment Scale
Time frame: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
Post-Delivery Perceived Stress Inventory
Time frame: Pre-treatment (intake assessment)
The Treatment Acceptability/Adherence Scale
Time frame: Pre-treatment (at the outset of treatment)
The Treatment Satisfaction Measure
Time frame: Immediately post-treatment
Change in scores on the The Hamilton Anxiety Rating Scale
Time frame: Pre-treatment; immediately post-treatment; 1-month post-treatment; 3-months post-treatment
The Homework Checklist
Time frame: From group treatment session two, up to five weeks.
The Treatment Protocol Adherence Checklist
Time frame: Completed by group leaders weekly, up to 6 weeks.
The Coronavirus Stressor Survey
Time frame: Pre-treatment (intake assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA) in people with Perinatal Anxiety, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Perceived Stress Scale (time frame: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.