Clinical trial NCT04581681: Group Cognitive Behavioural Therapy (CBT) for Perinatal Anxiety
Official title: Group Cognitive Behaviour Therapy for Perinatal Anxiety: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Anxiety
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in scores on the Perceived Stress Scale
timeFrame: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment up to 6 weeks
measure: Changes in scores on the Perinatal Anxiety Screening Scale
timeFrame: Pre-treatment (intake assessment); immediately post-treatment; 1- and 3-month follow-ups; and weekly during treatment, up to 6 weeks
Secondary outcomes:
measure: Change in scores on the The Edinburgh Postnatal Depression Scale
timeFrame: Pre-treatment (intake assessment), immediately post-treatment; 1-month follow-up; 3-month follow-up; and weekly during treatment, up to 6 weeks
measure: Change in scores on the Maternal Antenatal Attachment Scale
timeFrame: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
measure: Change in scores on the Maternal Efficacy Questionnaire
timeFrame: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
measure: Change in scores on the Maternal Postnatal Attachment Scale
timeFrame: Pre-treatment (intake assessment), immediately post-treatment, 1-month follow-up, 3-month follow-up
measure: Post-Delivery Perceived Stress Inventory
timeFrame: Pre-treatment (intake assessment)
measure: The Treatment Acceptability/Adherence Scale
timeFrame: Pre-treatment (at the outset of treatment)
measure: The Treatment Satisfaction Measure
timeFrame: Immediately post-treatment
measure: Change in scores on the The Hamilton Anxiety Rating Scale
timeFrame: Pre-treatment; immediately post-treatment; 1-month post-treatment; 3-months post-treatment
measure: The Homework Checklist
timeFrame: From group treatment session two, up to five weeks.
measure: The Treatment Protocol Adherence Checklist
timeFrame: Completed by group leaders weekly, up to 6 weeks.
measure: The Coronavirus Stressor Survey
timeFrame: Pre-treatment (intake assessment)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
Study officials:
References: