Building Emotion Awareness and Mental Health (BEAM): Community Partnership With Family Dynamics

NCT ID: NCT05398107

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-28
• Study Completion Date: 2022-12-30

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.

Conditions

Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: The BEAM program

The 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.

Group Type: EXPERIMENTAL

Experimental: Building Emotion Awareness and Mental Health (BEAM)

Intervention Type: BEHAVIORAL

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.

Standard of Care: MoodMission

MoodMission 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.

Group Type: ACTIVE_COMPARATOR

Control: MoodMission

Intervention Type: BEHAVIORAL

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.

Interventions

Experimental: Building Emotion Awareness and Mental Health (BEAM)

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.

Intervention Type: BEHAVIORAL

Control: MoodMission

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.

Intervention Type: BEHAVIORAL

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

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

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

Tactica Interactive

UNKNOWN

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie E Roos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Lianne Tomfohr-Madsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Manitoba - Department of Psychology

Winnipeg, Manitoba, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36895006 (View on PubMed)

Other Identifiers

BEAM FD

Identifier Type: -

Identifier Source: org_study_id