Group Cognitive Behavioural Therapy (CBT) for Perinatal Anxiety

NCT ID: NCT04581681

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-02
• Study Completion Date: 2023-01-30

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

Study Design

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

Study Groups

Group CBT for Perinatal Anxiety

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Waitlist Control

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

Group Type: ACTIVE_COMPARATOR

No treatment (waitlist control)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

No treatment (waitlist control)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

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

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Gillian Alcolado

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

H2020:095

Identifier Type: -

Identifier Source: org_study_id