Caria: Digital Intervention for Menopause Symptom
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Hot Flush Rating Scale
Study Overview
Brief Summary
Menopause is the time of life when menstrual cycles cease. Women typically spend 30-40% of their lives in menopause. Individual experiences of menopause vary and although some women do not experience any significant symptoms, common symptoms include vasomotor dysfunction, vaginal dryness, mood changes, sleep disturbances, urinary incontinence, cognitive changes, somatic complaints and sexual dysfunction. Reduced quality of life can occur as a result of these symptoms. A mobile app has been developed to reduce the impact of these symptoms using a variety of behavioral change techniques including education, goal setting, motivational enhancement, social support and cognitive behavioral approaches. Participants will complete self report assessments of women's symptoms and QOL at baseline, 3 weeks and 6 weeks of app use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women with variable menstrual cycles (menopausal transition) or those who were more than 1 year from their last menstrual period (postmenopause)
- •Hot flash/night sweats should be experienced as problematic (as indicated by an average score of 2 or higher on three items of the Hot Flush Rating Scale
- •Elevated score on at least one measure - either depression (PHQ8=10 or greater, sleep (PSQI of 5 or greater) or anxiety (GAD7=10 or greater)
- •Own an apple device able to run the Caria app
- •English speaking
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hot Flush Rating Scale
Time Frame: 6 weeks
A measure of self-reported hot flashes, night sweats and/or severity of hot flashes typically using a dairy to record the frequency and severity of hot flashes using a 4-point scale: mild, moderate, severe, very severe to provide a hot flash index (sum of the number of hot flashes multiplied by severity).
Secondary Outcomes
- Women's Health Questionnaire(6 weeks)
Investigators
Jennifer Duffecy
Associate Professor
University of Illinois at Chicago