Clinical trial NCT02850523: Cognitive Behavioural Group Therapy for Perinatal Anxiety
Official title: Cognitive Behavioural Group Therapy for Perinatal Anxiety: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Anxiety
Keywords: Cognitive-behavioural therapy (CBT)
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blind, randomized controlled trial was conducted to evaluate the effectiveness of a new group-based cognitive-behavioural therapy (CBGT) for women with anxiety during pregnancy or in the early postpartum.
Primary purpose: TREATMENT

Brief summary: This study evaluated the effectiveness of a 6-week, group-based, cognitive behavioural therapy (CGBT) program for women with anxiety disorders (with or without comorbid depressive symptoms) during pregnancy or early postpartum. The CBGT program was evaluated compared to a 6-week waitlist condition.

Detailed description: Anxiety disorders affect up to 15% of women in the perinatal period (i.e., pregnancy, postpartum) and are a serious mental health concern. Anxiety disorders often coexist with depression and result in high distress and an impaired ability for new mothers to take care of themselves and their babies. In spite of the high prevalence of anxiety disorders during pregnancy and postpartum, research and clinical attention in this area is lacking and no empirically supported psychological treatments exist. Further, since many pregnant or postpartum women are unable or choose not to take medication for their mental health symptoms, establishing an effective non-pharmacological alternative is imperative. Cognitive-behavioural therapy is a well established psychological treatment for anxiety and mood disorders, with moderate to large effect sizes (Cohen's d = 0.5-1.3). The investigators developed a novel group-based cognitive-behavioural treatment program (CBGT) for perinatal women with anxiety disorders. In an initial, single-sample pilot study (Green et al., 2015), a significant reduction in symptoms of anxiety and depression was found from pre to post-treatment, along with reported high levels of treatment satisfaction. The purpose of the current study is to evaluate the effectiveness of this treatment using a larger sample and a randomized controlled trial (RCT).

Eligibility criteria: Eligibility criteria:

1. 18-45 years of age
2. pregnant or within the first six months postpartum
3. principal diagnosis of an anxiety disorder with or without comorbid depression
4. not taking psychoactive medication or, if taking these medications, no change in dose and type ≥ 6 weeks prior to the baseline assessment
5. no changes in psychoactive medication during the 6-week CBT treatment or 6-week waitlist
6. fluent in English

Exclusion criteria:

1. severe depression or active suicidal ideation
2. current psychosis or substance use disorder

Primary outcomes:
measure: State-Trait Inventory of Cognitive and Somatic Anxiety (STICSA)
timeFrame: 6 weeks
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 weeks
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: 6 weeks
measure: Intolerance of Uncertainty Scale (IUS-12)
timeFrame: 6 weeks
measure: Multidimensional Perfectionism Scale (MPS)
timeFrame: 6 weeks
measure: Multidimensional Parenting Perfectionism Scale (MPPQ)
timeFrame: 6 weeks
measure: Parenting Sense of Competence Scale (PSOC)
timeFrame: 6 weeks
measure: Social Provisions Scale (SPS)
timeFrame: 6 weeks
measure: Abbreviated Dyadic Adjustment Scale (ADAS)
timeFrame: 6 weeks
measure: Perceived Stress Scale (PSS)
timeFrame: 6 weeks
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: 6 weeks
measure: WHO Disability Assessment Scale 2.0 (WHODAS)
timeFrame: 6 weeks
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: 6 weeks
measure: Montgomery-Asberg Depression Scale (MADRS)
timeFrame: 6 weeks
measure: Difficulties in Emotion Regulation Scale (DERS-II)
timeFrame: 6 weeks
measure: Worry Behaviors Inventory (WBI)
timeFrame: 6 weeks
measure: The Female Sexual Function Index (FSFI)
timeFrame: 6 weeks
measure: The Sexual Quality of Life - Female (SQoL-F)
timeFrame: 6 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 weeks
measure: Postpartum Bonding Questionnaire (PBQ)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Women's Health Concerns, St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Sheryl Green, PhD, C.Psych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Green SM, Haber E, Frey BN, McCabe RE. Cognitive-behavioral group treatment for perinatal anxiety: a pilot study. Arch Womens Ment Health. 2015 Aug;18(4):631-8. doi: 10.1007/s00737-015-0498-z. Epub 2015 Feb 5.
citation: Green SM, Donegan E, McCabe RE, Streiner DL, Furtado M, Noble L, Agako A, Frey BN. Cognitive Behavior Therapy for Women With Generalized Anxiety Disorder in the Perinatal Period: Impact on Problematic Behaviors. Behav Ther. 2021 Jul;52(4):907-916. doi: 10.1016/j.beth.2020.11.004. Epub 2020 Nov 20.