Augmented CBGT for Perinatal Anxiety During a Global Pandemic (COVID-19)

Covid19 Clinical Trial

Official title:

Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495803
• Other study ID #: CBT-COVID
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: May 2022
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe depression/suicidality
• Primary diagnosis other than an anxiety disorder
• Psychotic or current substance/alcohol use disorder

Related Conditions & MeSH terms

• Anxiety Disorders
• COVID-19
• Covid19
• Perinatal Anxiety

Intervention

Other:
• Cognitive Behavioural Group Therapy for Perinatal Anxiety
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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	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).	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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).	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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.	8 weeks