Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety

Официальное название

Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]

Вторичные конечные точки (12)

• Penn State Worry Questionnaire (PSWQ) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Generalized Anxiety Disorder 7 (GAD-7) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Worry Behaviors Inventory Perinatal Revised (WBI-P) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Intolerance of Uncertainty Scale (IUS) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Perceived Stress Scale (PSS). [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Difficulties in Emotion Regulation Scale (DERS) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Insomnia Severity Index (ISI). [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Anxiety Sensitivity Index (ASI-3) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Abbreviated Dyadic Adjustment Scale (ADAS) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Social Provisions Scale (SPS) [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]
• Illness Intrusiveness Rating Scale (IIRS). [Срок оценки: Change from pre-treatment (baseline) to one week post-treatment to and 3-month follow up.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05510752 · CBT-Psychoed-RCT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗