Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioural Group Therapy, Psychoeducation.
- Who it may be relevant to
- Registry conditions: Perinatal Anxiety. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral Cognitive Behavioural Group Therapy
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. - Behavioral Psychoeducation
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.
Primary outcome measures
- State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
Secondary outcome measures (12)
- Penn State Worry Questionnaire (PSWQ) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Generalized Anxiety Disorder 7 (GAD-7) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Edinburgh Postnatal Depression Scale (EPDS) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Worry Behaviors Inventory Perinatal Revised (WBI-P) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Intolerance of Uncertainty Scale (IUS) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Perceived Stress Scale (PSS). [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Difficulties in Emotion Regulation Scale (DERS) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Insomnia Severity Index (ISI). [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Anxiety Sensitivity Index (ASI-3) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Abbreviated Dyadic Adjustment Scale (ADAS) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Social Provisions Scale (SPS) [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
- Illness Intrusiveness Rating Scale (IIRS). [Time frame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05510752 · CBT-Psychoed-RCT