Cognitive Behavioural Group Therapy for Perinatal Anxiety (CBT-PA)

St. Joseph's Healthcare Hamilton

Status: Completed

Conditions: Perinatal Anxiety

Treatments: Other: Cognitive Behavioural Therapy for Perinatal Anxiety

Study type: Interventional

Funder types: Other

Identifiers

NCT02850523

TCRA-SG2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 86 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Experimental

Experimental group

Description:

After an initial assessment, the experimental group will receive 6 weekly sessions (2 hours long) of group Cognitive Behavioural Therapy for Perinatal Anxiety (n=6 per group) for perinatal anxiety. They will then be re-assessed at post-treatment and 3 months post-treatment to determine the effectiveness of the treatment and whether these effects are maintained 3 months after treatment.

Treatment:

Other: Cognitive Behavioural Therapy for Perinatal Anxiety

Waitlist Control

No Intervention group

Description:

After an initial assessment, the wait-list control group will not receive any treatment for 6 weeks. They will then be re-assessed after 6 weeks and this data will be used to compare this group to the experimental group to determine the effectiveness of the treatment. After this re-assessment they will be offered the same treatment as the experimental group: 6 weekly sessions (2 hours long) of group Cognitive Behavioural Therapy for Perinatal Anxiety