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

NCT ID: NCT04495803

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Perinatal Anxiety Covid19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive Behavioural Group Therapy for Perinatal Anxiety

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Sheryl Green

Clinical Health Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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CBT-COVID

Identifier Type: -

Identifier Source: org_study_id

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