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

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ClinicalTrials.gov Identifier: NCT03194802
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Nora Vincent, University of Manitoba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Chronic Behavioral: Sleeping Without Pills Program Behavioral: Self-monitoring Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Sleeping Without Pills (SWOP), an Online Drug Tapering Program
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : January 30, 2018

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




Primary Outcome Measures :
  1. Drug dose [ Time Frame: 6 weeks ]
    Dose (mg) of sleep medication

  2. Drug frequency [ Time Frame: 6 weeks ]
    Frequency of use of sleep medication


Secondary Outcome Measures :
  1. Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) [ Time Frame: 6 weeks ]
    maladaptive beliefs about sleep

  2. Insomnia Severity Index [ Time Frame: 6 weeks ]
    Concern about sleep and daytime impairment

  3. Multi-Dimensional Fatigue Inventory [ Time Frame: 6 weeks ]
    Daytime fatigue

  4. Epworth Sleepiness Scale [ Time Frame: 6 weeks ]
    Daytime sleepiness

  5. Work and Social Adjustment Scale [ Time Frame: 6 weeks ]
    Impact of sleep on work and living



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194802


Locations
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Canada, Manitoba
Clinical Health Psychology
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba

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Responsible Party: Dr. Nora Vincent, Clinical Psychologist, University of Manitoba
ClinicalTrials.gov Identifier: NCT03194802    
Other Study ID Numbers: H2017:066
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders