Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04745182
This is a single-arm pilot trial to examine the feasibility, acceptability, and preliminary efficacy of the 12-week, phone-delivered, Midlife Activity, Stress reduction, Time Efficiency, Resilience, and Youthfulness (MASTERY) intervention, which utilizes positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote well-being and physical activity in mid-life adults.
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Notify Me45 year–64 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
This is a single-arm proof-of-concept trial of a phone-delivered positive psychology-motivational interviewing (PP-MI) intervention, with content adapted to midlife persons. Midlife adults with low physical activity were recruited from outpatient clinics, completed baseline outcome measures (including wearing an accelerometer to measure activity for one week), completed the 12-week MASTERY intervention, and then completed a follow-up session to obtain repeat outcome information. The intervention, which involved weekly phone sessions with a trained study team member, included the completion of PP exercises, setting physical activity goals, and completion of activities to reduce midlife-specific stressors. The primary outcomes were feasibility and acceptability, and secondary outcomes included accelerometer-measured physical activity and self-report outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 12-week, phone-delivered intervention utilizing positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote physical activity and well-being in mid-life adults.
Time frame: 12 weeks
To assess the feasibility of the intervention
Time frame: 12 weeks
To assess how easy participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being very difficult and 10 being very easy.
Time frame: 12 weeks
To assess how useful participants found the assigned exercises. Ratings will be made on a scale of 0-10, with 0 being not at all useful and 10 being very useful.
Time frame: 12 weeks
To assess the feasibility of study procedures. We will divide the number of phone sessions completed by participants by the total number of phone sessions that could have been completed.
Time frame: Change from Baseline to 12 weeks
ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline and at 12 weeks. We will report change from baseline to 12 weeks in the average number of minutes of MVPA performed per day.
Time frame: Change in score from Baseline to 12 weeks
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of positive affect.
Time frame: Change in score from Baseline to 12 weeks
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of optimism.
Time frame: Change in score from Baseline to 12 weeks
The Hospital Anxiety and Depression Scale (HADS)-depression subscale will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of depression.
Time frame: Change in score from Baseline to 12 weeks
The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change will be calculated by subtracting the score at baseline from the score at 12 weeks. Higher scores indicate higher levels of anxiety.
Massachusetts General Hospital
Other
Acronym: MASTERY
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