Group Cognitive Behavioural Therapy (CBT) for Perinatal Anxiety

University of Manitoba

Status: Completed

Conditions: Perinatal Anxiety

Treatments: Other: No treatment (waitlist control); Behavioral: Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04581681

H2020:095

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Group CBT for Perinatal Anxiety

Experimental group

Description:

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

Treatment:

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

Waitlist Control

Active Comparator group

Description:

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

Treatment:

Other: No treatment (waitlist control)