Cognitive Behavioural Group Therapy for Perinatal Anxiety

NCT ID: NCT02850523

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-01-31

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).

Conditions

Perinatal Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

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.

Group Type: EXPERIMENTAL

Cognitive Behavioural Therapy for Perinatal Anxiety

Intervention Type: OTHER

The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population.

Waitlist Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioural Therapy for Perinatal Anxiety

The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population.

Intervention Type: OTHER

Eligibility Criteria

Exclusion Criteria

1. severe depression or active suicidal ideation

2. current psychosis or substance use disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Sheryl Green

Cinical Health Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheryl Green, PhD, C.Psych

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton

Locations

Women's Health Concerns, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 25652951 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34134830 (View on PubMed)

Other Identifiers

TCRA-SG2

Identifier Type: -

Identifier Source: org_study_id