Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety

St. Joseph's Healthcare Hamilton

Status and phase: Not yet enrolling; Phase 3

Conditions: Perinatal Anxiety

Treatments: Behavioral: Cognitive Behavioural Group Therapy; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT05510752

CBT-Psychoed-RCT

Details and patient eligibility

About

Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.

Enrollment: 216 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women 18 and older that are pregnant or between 0-12 months postpartum;
2. Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;
3. No concurrent psychological treatment;
4. Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;
5. Fluent in English, minimal grade 8 reading level.

Exclusion criteria

1. Severe depression/suicidality requiring acute intervention;
2. Women with psychotic or current substance use disorders,
3. medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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216 participants in 2 patient groups

Psychoeducation Group

Active Comparator group

Description:

Psychoeducation is the most commonly offered non-pharmacological treatment for perinatal distress, with the assumption that an understanding of perinatal distress, self-care and infant milestones will improve mental health outcomes. Psychoeducation has been shown to be effective in reducing the severity of perinatal anxiety and depression.

Treatment:

Behavioral: Psychoeducation

Cognitive Behavioural Group Therapy

Experimental group

Description:

Cognitive Behavioural Group Therapy (CBGT) is a well-established psychological treatment for anxiety and other mental health disorders. CBGT treatment for perinatal anxiety has shown significant reductions in anxiety (primary outcome), worry and depression from pre- to post-treatment when compared to a waitlist control condition. However, to be considered well-established, a treatment must be at least as effective as other active interventions. As such, the present study will compare CBGT to what is most commonly offered to perinatal women with a principal anxiety disorder (i.e., psychoeducation).

Treatment:

Behavioral: Cognitive Behavioural Group Therapy