Clinical trial NCT05398107: Building Emotion Awareness and Mental Health (BEAM): Community Partnership With Family Dynamics
Official title: Building Emotion Awareness and Mental Health (BEAM) Program for Mothers of Children 6-18 Months Old: A Pilot Randomized Control Trial and Community Partnership With Family Dynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: Mental health
Parenting
Maternal
Psychoeducation
E-health
mhealth
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Tactica Interactive
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-05-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot Randomized Controlled Trial will involve two arms. Participants randomized to the BEAM program or the standard of care, MoodMission. The experimental arm will include 40 mothers in the BEAM program while the standard of care will include 40 mothers. Randomization will be stratified based on the telehealth group timeslots mothers are available for.
Primary purpose: TREATMENT

Brief summary: Throughout the COVID-19 pandemic, postpartum depression and anxiety has increased dramatically. This is problematic as mothers in Manitoba must wait 12-18 months for therapeutic services. Children exposed to maternal mental illness in the first few years of life are at risk of negative lifelong adverse effects. Thus, the investigators of this project created and have tested The Building Emotion Awareness and Mental health (BEAM) program, which is an app-based mental health and parenting program for mothers of young children who are experiencing depression and/or anxiety. BEAM is now ready to be tested in partnership with an established community agency. This partnership will enable counsellors to provide expert-led mental health treatment to supplement and expand upon existing mental health services and will enable an established agency to address widespread unmet family mental health needs through the provision of mobile health (mHealth) content, training, and consultation. A two-arm pilot randomized controlled trial (RCT) with repeated measures will be used to evaluate the BEAM program compared to MoodMission (an evidence-based mHealth program) which will be the standard of care. Outcomes will be assessed to determine the effects of the BEAM program on reducing maternal mental health symptoms among a sample of 80 mothers who self-report moderate-to-severe symptoms of depression and/or anxiety (on the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7, respectively), meet criteria for a current major depressive episode and/or anxiety disorder (as determined on the Mini International Neuropsychiatric Interview) and have a child between the ages of 6 to 18 months old.

Detailed description: Maternal depression and anxiety levels have increased dramatically throughout the COVID-19 pandemic. Studies show as many as 25-30% of mothers are experiencing clinically significant symptoms. Children exposed to maternal depression early in life are more likely to experience irritable temperament, socio-emotional developmental impairments, sleep concerns, and are at a long-term risk of lifelong mental illness. Thus, given the high rate of young children born throughout the pandemic who were exposed to maternal depression and anxiety, there is a critical need to mitigate these potential negative impacts on young children. In Manitoba, there is a serious gap in mental health services, with mothers waiting upwards of 12-18 months for therapy on provincial waitlists. Typically, programs that address both child and mother mental health are effective. However, these programs are usually costly, require highly trained clinicians, and have lengthy waitlists. Mobile apps show promising results for treating depression and anxiety but are rarely targeted towards mothers. Many of these factors led the investigators of this project to create the Building Emotion Awareness and Mental health (BEAM) program, which is a mobile health (mHealth) program designed to mitigate the impacts of pandemic stress on family mental health and includes (1) expert-led psychoeducational and parenting strategies videos; (2) structured group sessions to enhance therapeutic content and build social supports; (3) a monitored online forum to enhance peer connection; and (4) symptom monitoring to track progress.

The pilot results for the BEAM program among mothers of infants has shown promising results. The investigators noted statistically significant reductions in depression, anxiety, parenting distress, and child internalizing symptoms following the intervention for BEAM participants versus participants in the standard of care. The investigators are now ready to partner with an established community agency, Family Dynamics, who will be provided with BEAM training and consultation. mHealth apps are usually delivered by third parties without involving trusted community agencies who have a sense of local needs and can offer additional supports if needed. Unfortunately, family agencies typically lack the infrastructure and personnel capacities to adequately treat maternal mental illness. The BEAM program will enable counsellors to provide expert-led mental health treatment which will supplement and expand upon existing services provided at Family Dynamics. This partnership approach with Family Dynamics will enable an established agency to address widespread unmet family mental health needs.

There are two primary aims to this study:

1. To determine the efficacy of BEAM compared to MoodMission, an app-based cognitive behavior therapy for treatment of moderate depression and anxiety, at reducing outcomes of interest in a randomized controlled trial (RCT). Primary (maternal depression and anxiety), secondary (maternal mental health, parenting, and child), and exploratory (relationship and weekly maternal mental health) outcomes will be assessed.
2. To examine the efficacy, feasibility, and acceptability of the BEAM program when delivered by a community agency, compared to MoodMission, while exploring opportunities for program development.

Eligibility criteria: Inclusion Criteria:

* Mother with a child 6 to 18 months old
* Moderate-to-severe symptoms of depression and/or anxiety (i.e., a score at or above 10 on the Patient Health Questionnaire and/or the General Anxiety Disorder scale)
* Comfortable understanding, speaking, and reading English
* Residing in the province of Manitoba, Canada
* Willing to complete pre-intervention, post-intervention, and follow-up questionnaires (approximately 45 minutes each)
* Willing to complete a one hour mental health interview with a trained student on the Mini International Neuropsychiatric Interview (MINI)
* Meets criteria for a major depressive episode or anxiety disorder (i.e., (i.e., panic disorder, agoraphobia, social anxiety disorder, post traumatic stress disorder, or generalized anxiety disorder)
* Availability to attend weekly telehealth sessions

Exclusion Criteria:

* Suicide attempt within the past year
* Self-harm in past 6 months
* Clinically significant psychotic symptoms on the MINI
* A diagnosis of post-traumatic stress disorder on the MINI which, in clinical opinion, would make it impossible for the mother to participate in the program
* A diagnosis of severe alcohol use disorder and/or a substance use disorder on the MINI which, in clinical opinion, would make it impossible for the mother to participate in the program
* Lives outside of Manitoba, Canada
* Does not meet criteria for moderate-to-severe depression and/or anxiety on the PHQ-9 and/or GAD-7
* Child is outside of the 6 to 18 month age range

Primary outcomes:
measure: Change in maternal depression
timeFrame: The PHQ-9 will be administered during the eligibility screening (up to 2 months before randomization), pre-intervention (T1), during the weekly surveys (up to 11 weeks), after the intervention (T2; after week 12), and at a 6-month follow-up (T3).
measure: Changes in maternal anxiety
timeFrame: The GAD-7 will be completed during the eligibility screening (up to 2 months before randomization), pre-intervention (T1), during the weekly surveys (up to 11 weeks), after the intervention (T2; after week 12), and at a 6-month follow-up (T3).
Secondary outcomes:
measure: Changes in parenting stress
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2: 11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Changes in maternal sleep disturbance
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2; 11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Changes in maternal anger
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2; 11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Change in maternal self-efficacy
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2;11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Change in maternal substance use
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2; 11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Change in maternal substance use motives
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2; 11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Change in relationship quality
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2; 11 weeks after start of intervention), and at a 6-month follow-up (T3).
measure: Change in child temperament
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention).
measure: Change in child quality of life
timeFrame: To be assessed pre-intervention (T1; up to 2 months before the start of the intervention), immediately after the intervention (T2; 11 weeks after start of intervention), and at a 6-month follow-up (T3).
Other outcomes:
measure: Usability of the BEAM program
timeFrame: To be assessed immediately after the intervention (T2; 11 weeks after start of intervention).
measure: Program engagement
timeFrame: To be assessed immediately after the intervention (T2; 11 weeks after start of intervention).
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba - Department of Psychology
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Leslie E Roos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
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