Augmented Cognitive Behavioural Group Therapy for Perinatal Anxiety During a Global Pandemic (COVID-19)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Cognitive Behavioural Group Therapy for Perinatal Anxiety (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Edinburgh Postnatal Depression Scale (EPDS)(8 weeks)
- Postpartum Bonding Questionnaire (PBQ)(8 weeks)
- Overall Anxiety Severity and Impairment Scale (OASIS)(8 weeks)
- Abbreviated Dyadic Adjustment Scale (ADAS)(8 weeks)
- Perceived Stress Scale (PSS)(8 weeks)
- Intolerance of Uncertainty Scale (IUS)(8 weeks)
- COVID-19 Stress Scales (CSS)(8 weeks)
- Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)(8 weeks)
- Penn State Worry Questionnaire (PSWQ)(8 weeks)
- Parenting Sense of Competence Scale (PSOC)(8 weeks)
- Social Provisions Scale (SPS)(8 weeks)
- Postpartum Specific Anxiety Scale (PSAS)(8 weeks)
- Maternal Antenatal Attachment Scale (MAAS)(8 weeks)
- Client Satisfaction Questionnaire (CSQ)(8 weeks)
Investigators
Sheryl Green
Clinical Health Psychologist
St. Joseph's Healthcare Hamilton