Group Cognitive Behavioural Therapy (CBT) For Perinatal Anxiety

NCT04581681 | Completed

• 1 other identifier: H2020:095
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in scores on the Perceived Stress Scale

  This is a 10-item self-report measure that assesses the extent to which one's life is appraised as stressful. Scores can range from 0 to 40, with higher scores indicating higher levels of perceived stress.

  Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks

• Changes in scores on the Perinatal Anxiety Screening Scale

  This is a 31-item self-report measure assessing symptoms of anxiety during the perinatal period. Scores on this measure can range from 0 to 93, with higher scores indicating higher levels of anxiety. It will be used in the current investigation to examine changes in anxiety symptoms across time.

  Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment, up to 6 weeks

Secondary Outcomes (11)

• Change in scores on the The Edinburgh Postnatal Depression Scale

  Pre-treatment (intake assessment), immediately post-treatment; 1-month follow-up; 3-month follow-up; and weekly during treatment, up to 6 weeks

• Change in scores on the Maternal Antenatal Attachment Scale

  Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up

• Change in scores on the Maternal Efficacy Questionnaire

  Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up

• Change in scores on the Maternal Postnatal Attachment Scale

  Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up

• Post-Delivery Perceived Stress Inventory

  Pre-treatment (intake assessment)

Study Arms (2)

Group CBT for Perinatal Anxiety

EXPERIMENTAL

Using cognitive-behavioural therapy principles, this group therapy is intended to treat perinatal anxiety.

Behavioral: Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)

Waitlist Control

ACTIVE COMPARATOR

This is a control condition in which patients are randomly assigned to the waitlist control condition before receiving the treatment.

Other: No treatment (waitlist control)

Interventions

Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA) BEHAVIORAL

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.

Group CBT for Perinatal Anxiety

No treatment (waitlist control) OTHER

Patients in this condition are randomly assigned to a waitlist control condition before receiving treatment.

Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult over the age of 18 years living in the province of Manitoba, Canada.
• Must be pregnant or within 12 months postpartum.
• Women must also meet criteria for at least one anxiety disorder or related disorder (i.e., generalized anxiety disorder, social anxiety disorder, panic disorder with or without agoraphobia, obsessive-compulsive disorder, or posttraumatic stress disorder).

You may not qualify if:

• Primary perinatal depression
• Active suicidality and/or homicidality
• Active psychosis, manic, or a substance use disorder that would interfere with participation in treatment.
• Women also must not be receiving concurrent psychotherapy
• If on medication, must not have made any medication changes in the 6 weeks prior to beginning participation in our study.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 9, 2020
• Study Start: December 2, 2020
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: May 5, 2026

Record last verified: 2024-06

Locations

CA (1)