Skip to main content
. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

Reilly‐Spong 2015.

Methods

  • Study design: parallel RCT; 388 assessed for eligibility, 63 randomised

  • Study duration: January 2010 to March 2012

  • Study follow‐up: 6 months
Participants

  • Country: USA

  • Setting: community

  • kidney transplant recipients aged ≥ 18 years

  • Number (randomised/analysed at 2 months/analysed at 6 months): intervention group 1 (31/24/20); intervention group 2 (232/27/22)

  • Mean age ± SD (years): intervention group 1 (52.6 ± 12.6); intervention group 2 (54.6 ± 11.7)

  • Sex (M/F): intervention group 1 (8/19); intervention group 2 (16/12)

  • Exclusion criteria: prior transplant, prior mindfulness‐based stress reduction or regular meditation practice; serious mental health concerns (suicidality, psychotic disorder, or substance abuse identified on screening by a psychologist); hospitalised or medically unstable (e.g. recent stroke); kidney transplant scheduled within the next 3 months
Interventions

  • Intervention type classification: behavioural counselling

  • eHealth intervention used: Telehealth


Intervention group 1

  • Telephone‐adapted mindfulness‐based stress reduction

    • Teleconferences used to deliver MBSR to make it more accessible for patients with ESKD.

    • Received recordings or practices in teachers voice to use at home

    • copy of “Full Catastrophe Living”

    • workbook (course guide and an educational workbook)

    • DVDs of “Mindful Movement and Stillness”

    • In‐person 5 hour workshops in weeks 1 and 8, separated by 90 min teleconferences in weeks 2‐7. Overall 19 hours of class time


Intervention group 2

    • Telephone‐adapted support group

    • To provide attention from a facilitator, group support and structured study activities to balance treatment arms with respect to known non‐specific effects of MBSR.

    • Provide content driven and highly structured intervention with an attentive instructor to elicit positive group experience and prevent lengthy or pervasively negative discussions of problems interpersonal communication skills and how to select health resources were selected as generic skills that would not overlap with MBSR

    • Skill building with homework assignments included Homework assignments designed by leader in weeks 1,6,7 but individual action commitments for other weeks.
Outcomes Primary outcome (measured at baseline, 2 months, 6 months)

  • Anxiety (state‐trait anxiety inventory STAI)


Secondary outcomes (measured at baseline, 2 months, 6 months)

  • depression (centre for epidemiological studies ‐ depression)

  • Insomnia (Pittsburgh Sleep Quality Index)

  • HRQoL (measured using SF‐12: mental and physical component scores, pain interference item)

  • Mindfulness (mindful attention awareness scale)

  • Worry (Penn‐state worry questionnaire)

  • Perceived stress (perceived stress scale PSS‐14)

  • Fatigue PROMIS fatigue short form

  • 2 subscales from KDQoL (impact and burden)

  • Actigraphy (sleep quantity and quality ‐ objective measure)

  • Salivary cortisol (objective biomarker or stress)


Other outcome (measured at 2 months)

  • Feasibility and acceptability (Intervention attendance: roll call and recorded weekly rosters, conference call records provided by teleconference vendor; treatment preference and expectations of intervention usefulness assessed on health and attitudes questionnaires; treatment fidelity measured by tallies of prescribed course elements on intervention checklists with weekly calls and occasional live monitoring by health psychologist)
Notes

  • Funding source: National Institute of Diabetes and Digestive and Kidney Diseases Award P01 DK013083 and National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR00011
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated using permuted blocks
Allocation concealment (selection bias) Low risk conducted by statistician who was masked. participants completed baseline assessments prior to randomisation
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Quote: "single blind"
Blinding of participants and personnel (performance bias) 
 Blinding of personnel High risk Unlikely could have been blinded / blinding would have been broken
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Objective measures (salivary cortisol and sleep actigraphy)
Blinding of outcome assessment (detection bias) 
 Subjective outcomes High risk Feasibility and acceptability measures taken with staff, QoL and anxiety measures are patient reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low loss to follow‐up (12.5% to 12.9%)
Selective reporting (reporting bias) High risk Salivary cortisol and sleep actigraphy and a number of emotional state outcomes were not reported in either paper
Other bias Unclear risk Insufficient information to permit judgement