Protocol - Your Answers When Needing Sleep in New Brunswick

NCT04406103 | Completed

• 1 other identifier: 2020-5184
• Study Type: interventional
• Target: 594
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia Chronic

Keywords

insomnia; benzodiazepines; deprescribing; cognitive-behavioural therapy for insomnia (CBTi)

Outcome Measures

Primary Outcomes (1)

• Number of participants discontinuing BZRA treatment within 6 months

  6 months

Secondary Outcomes (3)

• 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

  6 months

• Number of participants starting a new non-BZRA sedative-hypnotic

  6 months

Other Outcomes (13)

• Score on the Beliefs about Medicines Questionnaire (BMQ)

  baseline, 6 months

• Number of visits to mysleepwell.ca website

  6 months

• Time to fall asleep (minutes)

  baseline, 6 mo.

Study Arms (3)

Sleepwell

EXPERIMENTAL

Mailed information package includes 2 Sleepwell booklets (How to get your sleep back and How to stop sleeping pills)

Behavioral: Sleepwell

Empower

ACTIVE COMPARATOR

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

TAU

NO INTERVENTION

Treatment-as-usual group: no mailed intervention package.

Interventions

Sleepwell BEHAVIORAL

Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.

Sleepwell

Empower BEHAVIORAL

Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.

Empower

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• David Gardner: lead
• University of New Brunswick: collaborator
• Dalhousie University: collaborator

Study Sites (1)

University of New Brunswick

Fredericton, Nova Scotia, E3B 5A3, Canada

Location

Related Publications (2)

• Gardner DM, Turner JP, Magalhaes S, Rajda M, Murphy AL. Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. 2024 Dec 1;81(12):1187-1197. doi: 10.1001/jamapsychiatry.2024.2731.

  PMID: 39292452 DERIVED

• 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.

  PMID: 36045710 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• David M Gardner, PharmD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 28, 2020
• Study Start: November 6, 2020
• Primary Completion: October 31, 2022
• Study Completion: March 30, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)