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. 2017 Sep 14;8:99–105. doi: 10.1016/j.conctc.2017.09.002

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.