Protocol - Your Answers When Needing Sleep in New Brunswick (YAWNS NB)

Your Answers When Needing Sleep in New Brunswick (YAWNS NB): A Randomized Controlled Trial Comparing Sleepwell, EMPOWER, and Treatment as Usual for Benzodiazepine Receptor Agonist Discontinuation in Older Adults (Protocol)

New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian average of 10%. The rate of use is higher in women and increases with age, as do risks for serious harms.

Sleeping pills risks are substantial and costly, especially to seniors. Research does not support their long-term use. Risk for falls causing injuries, including hip fractures, is a leading concern. They impair mental and physical functioning resulting in a loss of independence and cause impaired driving and a higher rate of serious crashes. The rate of near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise. Stopping treatment can be difficult due to physical dependence and withdrawal symptoms.

Cognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these recommendations are not reflected in primary care practice.

Internationally, many educational interventions targeting prescribers have been tried, yet have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly to seniors in a clinical trial was associated with a large reduction in sleeping pill use. Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by providing specific information and recommendations regarding CBTi in addition to guidance on how to stop sleeping pills.

This study will evaluate the effectiveness of direct-to-patient interventions on long-term sleeping pill use.

Study Overview

• Status: Completed
• Conditions: Insomnia Chronic
• Intervention / Treatment: Behavioral: Sleepwell; Behavioral: Empower

Detailed Description

The investigators are proposing to investigate direct-to-patient health promotion interventions that promote sleeping pill dose reduction and treatment discontinuation by enhancing self-efficacy through various behaviour change techniques embedded in printed information provided to patients. Seniors will be invited to participate via direct telephone contact, information sharing through seniors' organizations, education sessions for seniors, and public notices. Prospective participants will be given the option of which way they would like to participate in the research:

Option 1: full participation including baseline interview, 6-month interview, and access to specific data from the participant's personal health record); Option 2: limited participation to baseline and 6-month interviews only; and Option 3: limited participation to baseline interview and access to specific data from the participant's personal health record.

This will form two sets of participants; those who do and those who do not permit access to outcomes from their personal health record. Participants that select Options 1 or 3 will consent to their medication and health resources use being assessed objectively over a six month period. Participants that choose Options 1 or 2 will directly provide baseline information about their health, medication use, and use of health resources via communications with researchers. Similar information will be collected directly from participants in this group after six months.

Random group allocation:

Options 1 and 2: i) Sleepwell package; ii) Empower package; iii) No package Option 3: i) Sleepwell package; ii) No package

The investigators will compare the rates of reducing and stopping sleeping pill use among the different groups over 6 months. Safety outcomes including falls and hospital visits will be measured. The investigators will also track participant access to online CBTi resources using Google Analytics.

Encouraging results from this study of direct-to-patient health promotion regarding insomnia management and sleeping pill use can be utilized repeatedly over time to reach all individuals who could benefit from the intervention, leading a transformational change in insomnia management.

• Study Type: Interventional
• Enrollment (Actual): 594
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Fredericton, Nova Scotia, Canada, E3B 5A3
      • University of New Brunswick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• residents of New Brunswick, Canada
• age 65 or older
• English speaking
• community dwelling with no anticipated change of address for the next 6 months
• current user of BZRAs (3 or more bedtime doses in previous 7 days)
• long-term user of BZRA: use 3 months or longer
• BZRA indication: insomnia.

Exclusion Criteria:

• using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin, diphenhydramine, dimenhyrdinate)
• use of alcohol or cannabis 3 or more nights a week for sleep problems
• diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs syndrome, narcolepsy, sleepwalking
• severe anxiety disorder
• obsessive compulsive disorder
• severe cognitive impairment
• dementia
• seizure disorder
• spinal injury
• chronic psychotic disorder (e.g., schizophrenia)
• bipolar disorder
• cancer
• receiving palliative care
• living in a Long Term Care facility

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleepwell; Mailed information package includes 2 Sleepwell booklets (How to get your sleep back and How to stop sleeping pills)	Behavioral: Sleepwell; Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
Active Comparator: Empower; Mailed information package includes 2 Empower booklets (You may be at risk AND How to get a good night's sleep without sleeping pills)	Behavioral: Empower; Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
No Intervention: TAU; Treatment-as-usual group: no mailed intervention package.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants discontinuing BZRA treatment within 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants discontinuing BZRA treatment within 3 months		3 months
Number of participants with BZRA dose change of 25% or more within 6 months	Relative change in BZRA dose between baseline and 6 months is 25% or greater.	6 months
Number of participants starting a new non-BZRA sedative-hypnotic	Newly started on other sedative-hypnotics	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score on the Beliefs about Medicines Questionnaire (BMQ)	BMQ	baseline, 6 months
Number of visits to mysleepwell.ca website	The count of website visits by study participants in the Sleepwell arm during 6 months	6 months
Time to fall asleep (minutes)	Sleep onset latency (SOL) measured in minutes	baseline, 6 mo.
Time spent asleep (minutes)	Total sleep time (TST) measured in minutes	baseline, 6 months
Sleep efficiency (%)	Time spent sleeping (min.) compared to total time spent in bed (min) x 100	baseline, 6 months
Score on the Epworth Sleepiness Scale	Assessment of daytime sleepiness	baseline, 6 months
Score on the Insomnia Severity Index		baseline, 6 months
Score on the Generalized anxiety disorder - 7		baseline, 6 months
Vulnerable elderly survey, 13-item version	A function-based self-reported brief survey to assess risk of functional decline and death	baseline, 6 months
Score on the Quality of life SF-12v2		baseline, 6 mo.
Number of participants reporting having a fall (subjective)		baseline, 6 months
Number of participants reporting having a fall-related health visit		baseline, 6 months
Responses to the prescriber acceptability survey	Prescribers will be invited to respond to this end-of-study survey assessing their acceptability of the Sleepwell intervention. The development of this survey was informed by the Theoretical Framework of Acceptability	6 months

Collaborators and Investigators

• Sponsor: David Gardner
• Collaborators: Dalhousie University; University of New Brunswick
• Investigators: Principal Investigator: David M Gardner, PharmD, Dalhousie University

Publications and helpful links

General Publications

• Murphy AL, Turner JP, Rajda M, Magalhaes S, Allen KG, Gardner DM. A protocol for a randomized controlled trial comparing Sleepwell, EMPOWER, and treatment-as-usual for benzodiazepine receptor agonist discontinuation in older adults: the your answers when needing sleep in New Brunswick (YAWNS NB) study. Explor Res Clin Soc Pharm. 2022 Aug 3;7:100164. doi: 10.1016/j.rcsop.2022.100164. eCollection 2022 Sep.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: insomnia; deprescribing; benzodiazepines; cognitive-behavioural therapy for insomnia (CBTi)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2020-5184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No