Skip to main content
. 2019 Dec 6;2019(12):CD011207. doi: 10.1002/14651858.CD011207.pub2

Fuller 2016.

Methods Design: cluster‐RT
Groups: intervention (Modified Brief Behavioural Intervention Insomnia (MBBTi)); control (usual care + information leaflet)
Participants Pharmacies: 12 (7 intervention; 5 control)
Pharmacy workers: not reported
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Pharmacy user: 56 insomniacs (22 intervention; 34 control)

  • mean age: intervention 53.5 ± 21.1 years; control 53.9 ± 6.1 years

  • % female: intervention 64.7% ; control 78.9%


Setting: unclear
Country: New South Wales, Australia
Interventions Pharmacy worker‐directed intervention: training on sleep and sleep management through interactive lectures, case study discussions, role play plus manual with details of sleep and MBBTi

  • Delivered by: sleep clinicians

  • Type: education

  • Mode of delivery: manual and face‐to‐face

  • TDF: knowledge, skills

  • Duration: workshop 7 hours

  • Follow‐up: 3 months (end of intervention)


Pharmacy worker control: control group manual provided detailed background information on sleep and sleep health, insomnia and its impact, models of insomnia and general insomnia treatment (pharmacological and sleep hygiene methods).
‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Pharmacy user‐directed intervention: standardised education + sleep restriction and/or stimulus control, goal setting, sleep diaries

  • Delivered by: pharmacists

  • Type: behavioural

  • Mode of delivery: face‐to‐face, workbook

  • TDF: knowledge, goals, behavioural regulation

  • Duration: 3 visits

  • Follow‐up: 3 months (end of intervention)


Pharmacy user control: usual care and information sheets on insomnia if needed
Outcomes Pharmacy worker:

  • Behavioural: interventions delivered by pharmacists


‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Pharmacy user:

  • Clinical: Insomnia Severity Score (ISI)

  • Psychological health: Depression, Anxiety, Stress Scale (DASS‐21)

  • Behavioural: not assessed

  • Quality of life: not assessed

  • Process: participants completed the Dysfunctional Beliefs About Sleep (DBAS‐16) questionnaire

  • Costs: not assessed
Notes Funding source: Scholarship Faculty Pharmacy, University of Sydney and CIRUS (Centre for Integrated Research into the Understanding of Sleep)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Used RAND function in Excel for simple randomisation
Allocation concealment (selection bias) High risk Incomplete allocation concealment
Baseline outcome measures similar Low risk MBBTi and control patients were similar at baseline
Baseline characteristics similar Low risk No significant differences between groups in any of the demographics
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Alternative analysis performed to allow for all available data to be used
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Pharmacists undertook data collection, but did not score key outcomes at follow‐up.
Protection against contamination Low risk Cluster randomised
Selective reporting (reporting bias) Low risk Not apparent
Other bias High risk Cluster effects not taken into account for all key outcomes other than the ISI.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Pharmacists were aware of participants' groups.