Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety

NCT05510752 | Not Yet Recruiting Phase 3

• 1 other identifier: CBT-Psychoed-RCT
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perinatal Anxiety

Outcome Measures

Primary Outcomes (1)

• State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

  The STICSA is a 21-item self-report scale that assesses cognitive and somatic components of anxiety. The STICSA is comprised of a state scale that measures individuals' current anxiety symptoms, and a trait scale that assesses one's proneness to anxiety, more generally. In the present study, only the trait scale of the STICSA will be used. Items are scored on a 4-point scale ranging from 1 ('not at all') to 4 ('very much so'). The STICSA has demonstrated excellent validity and reliability. A cut-off score of 43 or higher on the STICSA has been suggested for detecting a probable anxiety disorder. The STICSA has been validated for use in clinical samples of adults with anxiety disorders, although not explicitly in perinatal samples.

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

Secondary Outcomes (14)

• Penn State Worry Questionnaire (PSWQ)

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

• Generalized Anxiety Disorder 7 (GAD-7)

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

• Edinburgh Postnatal Depression Scale (EPDS)

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

• Worry Behaviors Inventory Perinatal Revised (WBI-P)

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

• Intolerance of Uncertainty Scale (IUS)

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

Other Outcomes (1)

• Sociodemographic Factors

  Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.

Study Arms (2)

Psychoeducation Group

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducation

Cognitive Behavioural Group Therapy

EXPERIMENTAL

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).

Behavioral: Cognitive Behavioural Group Therapy

Interventions

Cognitive Behavioural Group Therapy BEHAVIORAL

CBGT is a 6-week group that meets weekly for 2-hours per week, where participants learn cognitive and behavioural techniques to enhance coping skills for their everyday anxieties.

Cognitive Behavioural Group Therapy

Psychoeducation BEHAVIORAL

Psychoeducation is the most common non-pharmacological treatment for perinatal distress, where participants learn about healthy infant milestones and how to implement self-care in their daily lives, which in turn reduces distress during the perinatal period.

Psychoeducation Group

Eligibility Criteria

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

You may qualify if:

• Women 18 and older that are pregnant or between 0-12 months postpartum;
• 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;
• No concurrent psychological treatment;
• 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;
• Fluent in English, minimal grade 8 reading level.

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Central Study Contacts

Sheryl M Green, C.Psych

CONTACT

905-522-1155; sgreen@stjoes.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Clinical Psychologist

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 22, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share