Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety
ConditionPerinatal Anxiety
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSt. Joseph's Healthcare Hamilton
About this trial
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
Qualifiers
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;
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Cognitive Behavioural Group Therapy
- Psychoeducation
Treatment groups
216 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov