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

NCT04495803 | Completed

• 1 other identifier: CBT-COVID
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Anxiety; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Intolerance of Uncertainty Scale (IUS)

  8 weeks

• Penn State Worry Questionnaire (PSWQ)

  8 weeks

• Edinburgh Postnatal Depression Scale (EPDS)

  8 weeks

• COVID-19 Stress Scales (CSS)

  8 weeks

• Pregnancy-Related Anxiety Questionnaire-Revised (PRAQ-R2)

  8 weeks

Study Arms (1)

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.

Other: Cognitive Behavioural Group Therapy for Perinatal Anxiety

Interventions

Cognitive Behavioural Group Therapy for Perinatal Anxiety OTHER

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8P 3R2, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Health Psychologist

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 3, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

CA (1)