Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes
Recruiting · NCT05420051 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Motivational InterviewingPositive Psychology + Motivational Interviewing
What this trial is about
The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosis of Type 2 Diabetes
- Low physical activity (\<150 minutes/week of moderate to vigorous physical activity)
Exclusion criteria
- Cognitive deficits impeding a participant's ability to provide informed consent or participate
- Medical conditions likely to lead to death within 6 months.
- Pre-existing coronary artery disease
- Moderate-severe depression (Patient Health Questionnaire-9 \[PHQ-9\] score ≥15)
- Use of non-basal insulin
- Inability to participate in physical activity due to another medical condition
- Inability to receive text messages
- Inability to read, write, or speak in English
- Current participation in another intervention or program that has been designed to promote well-being or physical activity
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States