Table 2.
Methodological Changes to the WELL Study
| Changes to inclusion/exclusion criteria | Rationale |
| • Include those bereaved up to 8 months post death (instead of 6 months) | 1. Symptomatology is likely still due to spousal death and not some other event. |
| 2. At 7–8 months participants may now feel ‘ready’ to take on an additional activity | |
| • Include those on a stable dose of antidepressants; if on low dose, will ask PCP not to change dosage during study period. | 1. If not in a current episode of MDD, stable medication for the duration of the study is ok. |
| Changes to intervention protocol | |
| • Everyone chooses a health goal on which to focus during the course of the 12week intervention | 1. Will allow participants to feel personally invested in the study |
| • Provide a nutritional ‘cheat sheet’ | 1. Information about serving sizes allows participants to better record their nutritional intake |
| • Provide light encouragement once a month via phone call to the BSM-only arm | 1. Reduces patient boredom and increase retention and motivation |
| 2. Allows opportunity to ‘check-in’ with technology | |
| • Provide feedback (Actigraph data) about health behaviors in a ‘report card’ style at the end of the intervention period | 1. Feedback about performance is part of the spirit of MI |
| 2. For those in BSM only, feedback may increase motivation to stick with study | |
| • Provide option of a paper diary | 1. Increase retention among those with visual problems and/or arthritis who cannot see and/or use tablet |
| • Provide option of wearing Actigraph on wrist only | 1. Decreases participant burden from switching device from waist to wrist. Less likely to lose device around wrist |
| Changes to assessment schedule | |
| • Add HRSD to post-intervention and follow-up assessments | 1. HRSD is a more detailed assessment of depression (compared to PHQ-9) and is clinician administered. It may be able to detect specific change over time |
| • Monthly ICG assessments (if >=30 at BL) | 1. If ICG is greater than 30 may need targeted grief therapy |
| • Add a questionnaire about end-of-life experiences; circumstances surrounding their loved one’s death | 1. Information about the circumstances surrounding their spouse’s death (good death versus bad death) may impact the quantity of the intervention needed |
| • Add Social Rhythm Metric at BL | 1. Will provide information about bereaved elders’ rest/wake cycles |
| • Add heart rate and blood pressure at BL | 1. Physiological data of the bereaved are lacking. |