Perinatal AnxietyNCT04495803
Augmented CBGT for Perinatal Anxiety During a Global Pandemic (COVID-19)
A study testing Cognitive Behavioural Group Therapy for Perinatal Anxiety in people with Perinatal Anxiety and Covid19, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Perinatal Anxiety, Covid19
- What is being tested?
- Cognitive Behavioural Group Therapy for Perinatal Anxiety
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 1 Sep 2021
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females, aged 18-45 years
- Pregnant or up to six months postpartum
- Primary diagnosis of an anxiety disorder, as per the MINI for DSM-5, with or without comorbid depression
- No concurrent psychological treatment
- Not taking psychoactive medication or medication is stable in dose and type for at least 8 weeks prior to the study (as per Canadian Psychiatric Guidelines) and throughout study duration (participants will not be excluded from treatment if medication/dose changes during the study duration, however, they must notify the study team immediately)
- Fluent in English in order to understand the consent and group material
Who cannot join
- Severe depression/suicidality
- Primary diagnosis other than an anxiety disorder
- Psychotic or current substance/alcohol use disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)
This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.
- Conditions
- Perinatal Anxiety, Covid19
- Being tested
- Cognitive Behavioural Group Therapy for Perinatal Anxiety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Group Therapy for Perinatal AnxietyOther
The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population. Additional strategies for COVID-19 specific worry content have been included.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | After an initial assessment to confirm eligibility, the experimental group will receive 8 weekly sessions (2 hours long) of our augmented group CBT for perinatal anxiety during a global pandemic (n=6 per group). Participants will be re-assessed at post-treatment and at a 3-month follow-up to determine the effectiveness of the treatment and whether these effects are maintained in the long-term. Receives: Other: Cognitive Behavioural Group Therapy for Perinatal Anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
Changes in anxiety symptoms will be assessed through the STICSA to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.
Measured: 8 weeks
Secondary outcomes (14)
Intolerance of Uncertainty Scale (IUS)
Due to the level of ongoing uncertainty that exists surrounding COVID-19, changes in intolerance of uncertainty will be assessed by the 27-item IUS to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing intolerance of uncertainty. The IUS can be scored across two-factors, in addition to a total score. Factor 1 includes items assessing uncertainty as having negative behavioural and self-referent implications (e.g., uncertainty keeps me from living a full life) and Factor 2 assesses uncertainty as being unfair and spoiling things in life (e.g., I can't stand being taken by surprise). Items are rated on a 5-point Likert type scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).
Measured: 8 weeks
Penn State Worry Questionnaire (PSWQ)
Changes in worry symptoms will be assessed by the PSWQ. The PSWQ is a 16-item self-administered tool designed to assess worry symptoms. Items are assessed on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me), with higher scores indicating increased worry.
Measured: 8 weeks
Edinburgh Postnatal Depression Scale (EPDS)
Changes in mood symptoms will be assessed through the EPDS. Items on the EPDS are rated from 0-3, with higher total scores indicating more depressive symptoms. Possible scores on the EPDS range from 0-30. A clinical cut-off of 13 is used to indicate probable depression.
Measured: 8 weeks
COVID-19 Stress Scales (CSS)
Changes in worry and anxiety associated with COVID-19 will be examined using the CSS. The CSS is a 36-item self-report scale designed to measure worry and anxiety associated with the novel COVID-19 pandemic. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The CSS has 5 subscales: danger and contamination fears, fears about economic consequences, xenophobia, compulsive checking and traumatic stress symptoms.
Measured: 8 weeks
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)
Changes in pregnancy-specific anxiety will be assessed with the PRAQ-R2. Items are scored on 5-point Likert scale. Respondents are asked to circle the answer that applies most accurately to their situation and higher scores are reflective of greater pregnancy-specific anxiety. The PRAQ-R2 contains three subscales: fear of giving birth, worries about bearing a handicapped child, and concern about own appearance.
Measured: 8 weeks
Postpartum Specific Anxiety Scale (PSAS)
Changes in postpartum-specific anxiety will be assessed with the PSAS. Items are scored on a 4-point Likert scale (0-3), with higher scores indicating greater anxiety symptoms. The PSAS has 4 subscales: maternal competence and attachment, infant safety and welfare, practical infant care, and psychosocial adjustment to motherhood.
Measured: 8 weeks
Overall Anxiety Severity and Impairment Scale (OASIS)
Changes in severity and impairment associated with anxiety will be assessed with the OASIS. Respondents are asked to circle that answer that best describes their experience over the past week and items are scored on a 5-point Likert scale.
Measured: 8 weeks
Parenting Sense of Competence Scale (PSOC)
Changes in parenting self-efficacy will be assessed with the PSOC. The PSOC is a 17-item self-report scale, in which items are scored on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree), with higher scores reflecting greater parenting sense of competency.
Measured: 8 weeks
Abbreviated Dyadic Adjustment Scale (ADAS)
Changes in relationship satisfaction and adjustment will be assessed with the ADAS. The ADAS is a 7-item self-report scale, in which six of the items are scored on a 6-point Likert Scale, with higher scores reflecting greater relationship satisfaction. Item seven provides a global 'overall happiness' rating and is scored on 7-point Likert Scale ranging from 0 (extremely unhappy) to 6 (perfect).
Measured: 8 weeks
Social Provisions Scale (SPS)
Changes in perceived social support will be assessed with the SPS. Items are scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with higher scores indicating higher levels of perceived social support. The SPS has 6 subscales assessing dimensions of attachment, social integration, reassurance of worth, guidance, nurturance and reliance.
Measured: 8 weeks
Maternal Antenatal Attachment Scale (MAAS)
Changed in maternal attachment and bonding to the fetus will be assessed with the MAAS. For each item, respondents are asked to indicate the frequency in which each experience has occurred within the previous two weeks. The MAAS has two subscales that assess dimensions of quality of attachment and intensity of preoccupation. Items are scored on a 5-point Likert scale and scores range from 19 to 95 with higher scores indicating a higher level of attachment to the fetus.
Measured: 8 weeks
Postpartum Bonding Questionnaire (PBQ)
Changes in maternal bonding with the infant will be assessed with the PBQ. Items are scored on a 6-point Likert scale ranging from 0 (always) to 5 (never), with higher scores indicating lower levels of bonding with the infant. The PBQ has four subscales: general bonding, rejection and pathological anger, anxiety about the infant, and incipient abuse.
Measured: 8 weeks
Client Satisfaction Questionnaire (CSQ)
Client satisfaction of the augmented CBT for perinatal anxiety during a global pandemic will be assessed with the CSQ. Items are scored on a 4-point Likert scale from 1 to 4, with higher scores indicating higher levels of satisfaction with services.
Measured: 8 weeks
Perceived Stress Scale (PSS)
Changes in participants perceived level of stress will be assessed with the PSS. The PSS is a 14-item self-report scale, with items scored on a 5-point Likert scale from 0 to 4, with higher total scores indicating higher perceived stress.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheryl Green, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495803
- Sponsor's protocol ID
- CBT-COVID
- Status last verified
- May 2022
- First submitted
- 30 Jul 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)
- ClinicalTrials.gov ID
- NCT04495803
- Acronym / sponsor ID
- CBT-COVID
- Conditions
- Perinatal Anxiety, Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 3 Aug 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.
This study will evaluate the effectiveness of an augmented version of our current evidence-based Cognitive Behavioural Group Therapy (CBGT) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical COVID-related anxiety, worry, and impact content.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Cognitive Behavioural Group Therapy for Perinatal AnxietyAfter an initial assessment to confirm eligibility, the experimental group will receive 8 weekly sessions (2 hours long) of our augmented group CBT for perinatal anxiety during a global pandemic (n=6 per group). Participants will be re-assessed at post-treatment and at a 3-month follow-up to determine the effectiveness of the treatment and whether these effects are maintained in the long-term. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females, aged 18-45 years
- Pregnant or up to six months postpartum
- Primary diagnosis of an anxiety disorder, as per the MINI for DSM-5, with or without comorbid depression
- No concurrent psychological treatment
- Not taking psychoactive medication or medication is stable in dose and type for at least 8 weeks prior to the study (as per Canadian Psychiatric Guidelines) and throughout study duration (participants will not be excluded from treatment if medication/dose changes during the study duration, however, they must notify the study team immediately)
Key exclusion criteria (3 listed)
- Severe depression/suicidality
- Primary diagnosis other than an anxiety disorder
- Psychotic or current substance/alcohol use disorder
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 |
|---|---|---|
| Cognitive Behavioural Group Therapy for Perinatal AnxietyThe treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population. Additional strategies for COVID-19 specific worry content have been included. | Other | Experimental |
Primary outcome
State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
Time frame: 8 weeks
Changes in anxiety symptoms will be assessed through the STICSA to examine whether our augmented CBT for perinatal anxiety during a global pandemic is effective in reducing anxiety symptoms. Items on the STICSA are rated on a 4-point likert scale ranging from 1 (not at all) to 4 (very much so), with higher scores indicating worse anxiety symptoms. The STICSA has two subscales (i.e., cognitive subscale and somatic subscale) and a total score that will be used in analysis. Ten items comprise the cognitive subscale, meaning scores can range from 10-40. Eleven items comprise the somatic subscale, meaning scores can range from 11 -44. The total score is a sum of both subscales with possible total scores in the range of 21-84.
14 secondary outcomes
Intolerance of Uncertainty Scale (IUS)
Time frame: 8 weeks
Penn State Worry Questionnaire (PSWQ)
Time frame: 8 weeks
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: 8 weeks
COVID-19 Stress Scales (CSS)
Time frame: 8 weeks
Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)
Time frame: 8 weeks
Postpartum Specific Anxiety Scale (PSAS)
Time frame: 8 weeks
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 8 weeks
Parenting Sense of Competence Scale (PSOC)
Time frame: 8 weeks
Abbreviated Dyadic Adjustment Scale (ADAS)
Time frame: 8 weeks
Social Provisions Scale (SPS)
Time frame: 8 weeks
Maternal Antenatal Attachment Scale (MAAS)
Time frame: 8 weeks
Postpartum Bonding Questionnaire (PBQ)
Time frame: 8 weeks
Client Satisfaction Questionnaire (CSQ)
Time frame: 8 weeks
Perceived Stress Scale (PSS)
Time frame: 8 weeks
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 4 May 2022.
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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 Cognitive Behavioural Group Therapy for Perinatal Anxiety in people with Perinatal Anxiety and Covid19, run by St. Joseph's Healthcare Hamilton 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 6 inclusion and 3 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 4 May 2022. 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?
State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA) (time frame: 8 weeks). 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 4 May 2022.