NCT04581681

Group Cognitive Behavioural Therapy (CBT) for Perinatal Anxiety

Group Cognitive Behaviour Therapy for Perinatal Anxiety: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Manitoba · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our previous pilot study (N = 40) suggested that group Cognitive Behaviour Therapy for perinatal anxiety (CBT-PA) significantly reduces symptoms of anxiety and depression from pre- to post- intervention. CBT-PA is based on the general principles of CBT but specific themes and examples are geared towards pregnancy and postpartum periods. The 6-week treatment protocol addresses: (1) understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. This intervention and all assessment interviews will be conducted via a hospital-approved video-conferencing platform. All assessment questionnaires will be completed on SurveyGizmo. The objectives of the present study are: (1) to replicate these findings of the pilot study in a larger sample (N = 58) in a randomized controlled trial (RCT), (2) compare the effectiveness of CBT-PA to a control treatment (waitlist control), (3) evaluate the durability of treatment gains at 1-month and 3-months after the conclusion of treatment, (4) evaluate patient preferences in terms of the relevance and the acceptability of the CBT-PA protocol, (5) examine whether the degree of childbirth stress impacts patient response to CBT-PA to inform future refinements to the treatment, and (6) determine whether CBT-PA improves maternal efficacy and attachment with baby. This research is being conducted because many women suffer from perinatal anxiety and have difficulty accessing services in a timely manner. It is the hope that the findings of this study will have clinical significance in terms of providing additional support for CBT as an effective treatment for perinatal anxiety. It is the hope that this treatment will have mental and physical health benefits for the mothers directly, as well as mental and physical health benefits to their fetuses and infants.

Conditions

• Perinatal Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)	The 6-session group CBT intervention for perinatal anxiety has been formalized with session guides for the facilitators and a workbook, "Overcoming Anxiety in Pregnancy and Postpartum" (Furer \& Reynolds, 2015), developed by members of our Anxiety Disorders Clinic. There are 6 core modules covered over the 6 treatment sessions, including: (1) Understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. Content is based on general principles of CBT for anxiety but specific themes and examples are geared towards the pregnancy and postpartum periods. Distorted cognitions are also explored, with an additional focus on beliefs about motherhood and perfectionism. Due to the COVID-19 pandemic, the intervention will be conducted via a hospital-approved video-conferencing platform.
OTHER	No treatment (waitlist control)	Patients in this condition are randomly assigned to a waitlist control condition before receiving treatment.

Timeline

• Start date: 2020-12-02
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2020-10-09
• Last updated: 2024-11-18

Locations

1 site across 1 country: Canada