Internet-based Treatment for Chronic Insomnia

• ClinicalTrials.gov Identifier: NCT00821041
• Recruitment Status: Completed
• First Posted: January 12, 2009
• Results First Posted: September 16, 2011
• Last Update Posted: August 8, 2013
• Sponsor: University of Manitoba
• Information provided by (Responsible Party): Dr. Nora Vincent, University of Manitoba

Tracking Information

• First Submitted Date: January 8, 2009
• First Posted Date: January 12, 2009
• Results First Submitted Date: May 5, 2011
• Results First Posted Date: September 16, 2011
• Last Update Posted Date: August 8, 2013
• Study Start Date: September 2006
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2011)

Sleep Quality [ Time Frame: 6 weeks ]

Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?" And "How enjoyable was your sleep last night?" (0 = not at all, 4 = very).

• Original Primary Outcome Measures (submitted: January 9, 2009): Sleep Quality [ Time Frame: 5 weeks ]

Current Secondary Outcome Measures (submitted: August 13, 2011)

• Pre-Sleep Arousal [ Time Frame: 6 weeks ]
  Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal.
• Beliefs and Attitudes About Sleep [ Time Frame: 6 weeks ]

Original Secondary Outcome Measures (submitted: January 9, 2009)

• Pre-Sleep Arousal [ Time Frame: 5 weeks ]
• Beliefs and Attitudes About Sleep [ Time Frame: 5 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Internet-based Treatment for Chronic Insomnia
• Official Title: Evaluation of an Internet-based Treatment for Chronic Insomnia

Brief Summary

Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.

Design This is a randomized controlled trial with online treatment and waiting list control conditions.

Participants

Participants are adults in Manitoba Canada with chronic insomnia.

Setting

Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Insomnia
• Insomnia Disorder

Intervention

Behavioral: Cognitive Behavioral Therapy

6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training

Other Name: CBT

Study Arms

• No Intervention: Waiting list control
• Experimental: CBT
  A 6 weeks online course. Each week participants log on to view videos and read information that focus on a variety of intervention techniques. These include relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training. Participants also monitor their sleep using an online sleep diary and respond to questions regarding their adherence to the program.
  Intervention: Behavioral: Cognitive Behavioral Therapy

• Publications *: Vincent N, Walsh K, Lewycky S. Determinants of success for computerized cognitive behavior therapy: examination of an insomnia program. Behav Sleep Med. 2013;11(5):328-42. doi: 10.1080/15402002.2012.700662. Epub 2013 Jan 3.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 13, 2011): 118
• Original Estimated Enrollment (submitted: January 9, 2009): 200
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Access to high speed internet, insomnia duration > 6 months and occurring at least 4 nights per week, sleep-onset latency > 30 minutes and/or time awake at night > 30 minutes, and/or early morning awakening > 30 minutes before desired time, at least one type of daytime impairment.

Exclusion Criteria:

• Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake > 14 drinks/week for males, > 12 drinks per week for females, current or past behavioral treatment for insomnia

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00821041
• Other Study ID Numbers: H2004:112; HSCF 176
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Nora Vincent, University of Manitoba
• Study Sponsor: University of Manitoba
• Collaborators: Not Provided

Investigators

• Principal Investigator: Norah Vincent, Ph.D.; University of Manitoba

• PRS Account: University of Manitoba
• Verification Date: August 2013