Building Emotion Awareness and Mental Health (BEAM): Community Partnership With Family Dynamics
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2022
CompletedFirst Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMarch 22, 2023
March 1, 2022
6 months
April 26, 2022
March 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in maternal depression
Symptoms of depression will be assessed using the Patient Health Questionnaire-9. The Patient Health Questionnaire-9 is a self-administered questionnaire with possible scores ranging from 0 to 27, where higher scores are indicative of more severe symptoms. Data analyses will assess total Patient Health Questionnaire-9 scores as well as cut-off scores (≥ 10).
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).
Changes in maternal anxiety
Symptoms of anxiety will be assessed using the Generalized Anxiety Disorder 7-Item scale. The Generalized Anxiety Disorder-7 Item is a self-administered questionnaire with possible scores ranging from 0 to 21, where higher scores are indicative of more severe symptoms. Data analyses will assess total Generalized Anxiety Disorder-7 Item scores as well as cut off scores (≥ 10).
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 (9)
Changes in parenting stress
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).
Changes in maternal sleep disturbance
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).
Changes in maternal anger
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).
Change in maternal self-efficacy
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).
Change in maternal substance use
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).
- +4 more secondary outcomes
Other Outcomes (2)
Usability of the BEAM program
To be assessed immediately after the intervention (T2; 11 weeks after start of intervention).
Program engagement
To be assessed immediately after the intervention (T2; 11 weeks after start of intervention).
Study Arms (2)
Experimental: The BEAM program
EXPERIMENTALThe BEAM Program is delivered through a mobile application, weekly group telehealth sessions, and an online community forum. BEAM includes \~ 20 minutes of weekly video modules on parenting and mental health. Mental health videos provide content and emotion-regulation strategies drawn from the Unified Protocol, an evidence-based treatment for depression and anxiety disorders. Self-compassion and effective communication are also central focuses of the mental health content. Supportive parenting videos will provide mothers with emotion-focused parenting strategies and help mothers understand and respond to their children's challenging emotions and behaviours. The weekly group telehealth sessions will allow mothers to discuss content and ask questions, with the purpose of developing a sense of community and social support. The online community forum will provide a space for mothers to reflect on their learned skills and connect with other mothers taking part in the program.
Standard of Care: MoodMission
ACTIVE COMPARATORMoodMission is an evidence-based app which was developed based on cognitive behavioural therapy (CBT). The MoodMission app will provide mothers with missions. Missions are mental health strategies based on scientific evidence which are easily achievable (e.g., relaxation tips, exercise and fitness activities, yoga, mindfulness meditations, affirmations and coping statements). MoodMission will tailor missions based on the mothers current mood.
Interventions
The BEAM Program is based on best-practices in telehealth and science-based program design aimed at promoting maternal mental health and supportive parenting. The BEAM Program app is hosted on the University of Manitoba secure servers and is designed/managed by Tactica Interactive. The weekly group telehealth sessions will be led by clinical coaches (a mental health professional or Doctoral-Level Clinical Psychology Student) and will use the secure videoconferencing platform Zoom (Healthcare license). Parent coaches will be mothers who have recently participated in a prior iteration of the BEAM program. Parent coaches will engage with participants on the community peer support forum and will also attend weekly telehealth sessions. The therapeutic aims of the BEAM program are to improve symptoms of anxiety and depression as well as parenting skills, and will emphasize self-compassion, effective communication practices, and social support networks.
MoodMission will be used as our Standard of Care control group. MoodMission is an app based on CBT principles which creates tailored "missions" for mothers. These missions are based on self-reported mood and are aimed to improve mental health symptoms.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- University of Calgarycollaborator
- Tactica Interactivecollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
University of Manitoba - Department of Psychology
Winnipeg, Manitoba, R3T 2N2, Canada
Related Publications (1)
Joyce KM, Rioux C, MacKinnon AL, Katz LY, Reynolds K, Kelly LE, Klassen T, Afifi TO, Mushquash AR, Clement FM, Chartier M, Xie EB, Penner KE, Hunter S, Berard L, Tomfohr-Madsen L, Roos LE. The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial. Pilot Feasibility Stud. 2023 Mar 9;9(1):35. doi: 10.1186/s40814-023-01260-y.
PMID: 36895006DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie E Roos, PhD
University of Manitoba
- PRINCIPAL INVESTIGATOR
Lianne Tomfohr-Madsen, PhD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2022
First Posted
May 31, 2022
Study Start
January 28, 2022
Primary Completion
July 30, 2022
Study Completion
December 30, 2022
Last Updated
March 22, 2023
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data is expected to be available in early 2024.
De-identified data (e.g. standardized questionnaire responses, aggregated program use data, sociodemographics linked to an identifier number) may be made available on public data platforms such as open science framework or a requirement by a granting agency or journal.