Experimental: Building Emotion Awareness and Mental Health (BEAM) for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Manitoba - Department of Psychology, Winnipeg, Canada
Depression+1 More
Experimental: Building Emotion Awareness and Mental Health (BEAM) - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Depression
  • Anxiety

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 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).

Month 2
Changes in maternal anxiety
Month 2
Change in maternal depression
Week 11
Program engagement
Usability of the BEAM program
Month 2
Changes in parenting stress
Month 2
Change in child quality of life
Change in maternal substance use
Change in maternal substance use motives
Change in relationship quality
Changes in maternal anger
Changes in maternal sleep disturbance
Month 2
Change in maternal self-efficacy
Month 2
Change in child temperament

Trial Safety

Trial Design

2 Treatment Groups

Standard of Care: MoodMission
1 of 2
Experimental: The BEAM program
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental: Building Emotion Awareness and Mental Health (BEAM) · No Placebo Group · N/A

Experimental: The BEAM program
Behavioral
Experimental Group · 1 Intervention: Experimental: Building Emotion Awareness and Mental Health (BEAM) · Intervention Types: Behavioral
Standard of Care: MoodMission
Behavioral
ActiveComparator Group · 1 Intervention: Control: MoodMission · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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).
Closest Location: University of Manitoba - Department of Psychology · Winnipeg, Canada
Photo of manitoba 1Photo of manitoba 2Photo of manitoba 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Depression
0 CompletedClinical Trials

Who is running the clinical trial?

Tactica InteractiveUNKNOWN
2 Previous Clinical Trials
200 Total Patients Enrolled
2 Trials studying Depression
200 Patients Enrolled for Depression
University of CalgaryOTHER
692 Previous Clinical Trials
449,749 Total Patients Enrolled
25 Trials studying Depression
10,162 Patients Enrolled for Depression
University of ManitobaLead Sponsor
533 Previous Clinical Trials
186,031 Total Patients Enrolled
15 Trials studying Depression
1,015 Patients Enrolled for Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,216 Previous Clinical Trials
24,391,934 Total Patients Enrolled
43 Trials studying Depression
3,275,108 Patients Enrolled for Depression
Leslie E Roos, PhDPrincipal InvestigatorUniversity of Manitoba
2 Previous Clinical Trials
180 Total Patients Enrolled
1 Trials studying Depression
140 Patients Enrolled for Depression
Lianne Tomfohr-Madsen, PhDPrincipal InvestigatorUniversity of Calgary
4 Previous Clinical Trials
268 Total Patients Enrolled
2 Trials studying Depression
201 Patients Enrolled for Depression

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a major depressive episode or anxiety disorder.
You have a child 6 to 18 months old.
You are a Canadian citizen or resident.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.