Efficacy of Sleeping Without Pills (SWOP), an Online Drug Tapering Program

The aims of the study are to determine whether an online drug tapering program can lead to successful drug tapering in hypnotic dependent insomnia and whether such tapering is associated with improved daytime functioning and sleep.

Study Overview

• Status: Completed
• Conditions: Insomnia Chronic
• Intervention / Treatment: Behavioral: Sleeping Without Pills Program; Behavioral: Self-monitoring

Detailed Description

Insomnia is defined as difficulty with falling asleep, staying asleep, or early morning awakening. Chronic insomnia is estimated to affect 9-15% of the world's population. Lack of sleep increases a person's risk for many chronic diseases such as obesity, diabetes, cardiovascular disease, anxiety and depression. The two types of treatment available for chronic insomnia are cognitive behavioural therapy (CBT) and pharmacotherapy, the latter of which includes benzodiazepines and non-benzodiazepines.

The use of hypnotic medications is intended to be prescribed as a short-term treatment of one or two weeks, however this is not the case most of the time. Hypnotic abuse and dependency are prevalent issues that increase with advancing age. With the regular intake of these substances comes many adverse effects such as sedation, cognitive and psychomotor effects, falls and other accidents. Relative to non-drug users, cognitive events are 5.0 times more likely, psychomotor events are 3.0 times more likely, and daytime fatigue is 4.0 times more likely among drug users. Both non-benzodiazepines and benzodiazepines have the potential for dependency and withdrawal, although zolpidem and other non-benzodiazepine hypnotic agents have become the preferred drugs to manage insomnia due to the lower side effect profile. Withdrawal symptoms are associated with a rapid dose decrease or abrupt discontinuance of medication. These symptoms include rebound insomnia, anxiety, memory and concentration impairments and in severe states, psychotic symptoms, delirium and epileptic seizures.

A recent comparison of cost data associated with pharmacotherapy and cognitive behavioral therapy showed that CBT was significantly less costly than pharmacotherapy. Unfortunately, CBT is often not applied due to limited access to appropriately trained practitioners. The combination of equivalent efficacy, reduced costs, and favorable side-effect profile have made cognitive behavioural therapy (CBT) the preferred treatment for insomnia as evidenced by endorsements with the American Academy of Sleep Medicine. More recently, the delivery of CBT for insomnia has been enhanced to be provided through web-based portals. A number of web-based programs for insomnia have been developed with promising results. Some of these programs measured hypnotic use.

The effect size associated with online CBT (without drug tapering component) on reducing hypnotic drug use has been small, and these studies have employed a mix of participants, only some of whom are interested in tapering with variable levels of motivation. Studies comparing CBT plus drug tapering with drug tapering alone using booklets and in-person sessions have found that such interventions are moderately effective in reducing dosage and frequency of sleep medication usage.

The aims of the study are to determine whether an online drug tapering program (Sleeping without Pills; SWOP) can lead to successful drug tapering in hypnotic dependent insomnia (primary aim), and whether such tapering is associated with improved daytime functioning and sleep (secondary aims).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Clinical Health Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

a) >= 18 years, b) access to high speed internet and computer, c) disturbance of sleep consisting of a delay in sleep onset, return to sleep or early morning awakening at least 3 nights/week for at least 3 months in duration, d) at least one symptom of daytime impairment, use of medication to promote sleep, e) use of medication to promote sleep (either <= 1mg lorazepam, <= .5mg clonazepam, <= 7.5mg zopiclone, <= 50 mg trazodone/amitriptyline, f) interested in medication tapering.

Exclusion Criteria:

a) shift work, b) head injury, c) acute crisis, d) seizure disorder, e) use of psychotropic drugs for problems other than sleep, f) use of medication interfering with sleep, g) recreational drug use, h) symptoms suggestive of alternative sleep disorder that is untreated, i) elevated use of alcohol (> 14 beverages/week for males, >12 beverages per week for females)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sleeping Without Pills Program; Cognitive behavioral therapy; Motivational Interviewing; Scheduled and gradual drug tapering	Behavioral: Sleeping Without Pills Program; Participants receive this program online and are asked to log in daily for 6 weeks.
ACTIVE_COMPARATOR: Self-Monitoring; Daily Self-monitoring of sleep and sleep medication using sleep diary	Behavioral: Self-monitoring; Participants enter sleep diary data online daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug dose	Dose (mg) of sleep medication	6 weeks
Drug frequency	Frequency of use of sleep medication	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)	maladaptive beliefs about sleep	6 weeks
Insomnia Severity Index	Concern about sleep and daytime impairment	6 weeks
Multi-Dimensional Fatigue Inventory	Daytime fatigue	6 weeks
Epworth Sleepiness Scale	Daytime sleepiness	6 weeks
Work and Social Adjustment Scale	Impact of sleep on work and living	6 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2017
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): January 30, 2018

Study Registration Dates

• First Submitted: June 19, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (ACTUAL): June 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: H2017:066

Drug and device information, study documents

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