Clinical trial NCT05510752: Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety
Official title: Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Perinatal Anxiety
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Secondary outcomes:
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Worry Behaviors Inventory Perinatal Revised (WBI-P)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Intolerance of Uncertainty Scale (IUS)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Perceived Stress Scale (PSS).
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Insomnia Severity Index (ISI).
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Anxiety Sensitivity Index (ASI-3)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Abbreviated Dyadic Adjustment Scale (ADAS)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Social Provisions Scale (SPS)
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Illness Intrusiveness Rating Scale (IIRS).
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: World Health Organization Quality of Life Scale (WHOQoL-BREF).
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: One week post-treatment
Other outcomes:
measure: Sociodemographic Factors
timeFrame: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.
Locations:
Study officials:
References: