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

NCT03194802 | Completed

• 1 other identifier: H2017:066
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (2)

• Drug dose

  Dose (mg) of sleep medication

  6 weeks

• Drug frequency

  Frequency of use of sleep medication

  6 weeks

Secondary Outcomes (5)

• Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)

  6 weeks

• Insomnia Severity Index

  6 weeks

• Multi-Dimensional Fatigue Inventory

  6 weeks

• Epworth Sleepiness Scale

  6 weeks

• Work and Social Adjustment Scale

  6 weeks

Study Arms (2)

Sleeping Without Pills Program

EXPERIMENTAL

Cognitive behavioral therapy; Motivational Interviewing; Scheduled and gradual drug tapering

Behavioral: Sleeping Without Pills Program

Self-Monitoring

ACTIVE COMPARATOR

Daily Self-monitoring of sleep and sleep medication using sleep diary

Behavioral: Self-monitoring

Interventions

Sleeping Without Pills Program BEHAVIORAL

Participants receive this program online and are asked to log in daily for 6 weeks.

Sleeping Without Pills Program

Self-monitoring BEHAVIORAL

Participants enter sleep diary data online daily for 6 weeks

Self-Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Clinical Health Psychology

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Sleep; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: June 5, 2017
• Primary Completion: November 30, 2017
• Study Completion: January 30, 2018
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

CA (1)