InsomniaNCT01162655
Cognitive-Behavioural Therapy (CBT) for Insomnia Via Internet or Telehealth
A study testing Cognitive-behavioral therapy for Insomnia (CBT) in people with Insomnia, run by University of Manitoba at 1 site in Canada.
Trial summary
Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive-behavioral therapy for Insomnia (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be residents of rural Manitoba (Canada)
- Must meet research diagnostic criteria for insomnia
- Must have access to a computer and high-speed internet
Who cannot join
- Comorbid conditions (medical and psychiatric) must be stable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet
Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.
- Conditions
- Insomnia
- Being tested
- Cognitive-behavioral therapy for Insomnia (CBT)
- Keywords
- Insomnia, Cognitive-Behavioral Therapy, Internet, Telehealth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapy for Insomnia (CBT)Behavioural
6-week course of CBT delivered either using internet or telehealth
| Study group | Role | What they receive |
|---|---|---|
| Telehealth | Experimental | Complete CBT group via telehealth Receives: Behavioral: Cognitive-behavioral therapy for Insomnia (CBT) |
| Internet | Experimental | Complete Internet-based CBT program Receives: Behavioral: Cognitive-behavioral therapy for Insomnia (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity
The primary outcome measure will be insomnia severity, as assessed by the Insomnia Severity Index (ISI; Morin, 2003), a 6-item self-report measure of impairment due to sleep difficulties
Measured: 6 weeks
Secondary outcomes (1)
Sleep diary data
Sleep diaries are a standard daily outcome measure for insomnia. The version used here (Morin, 1993) includes information regarding total sleep time, sleep-onset latency, sleep-efficiency, number of night awakenings, time awake in then night, sleep quality, and frequency of use of sleep medications.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Responsible party
- Principal investigator, Dr. Maxime Holmqvist, University of Manitoba
- Investigators
- Maxine Holmqvist, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162655
- Sponsor's protocol ID
- H2009:110
- Status last verified
- May 2017
- First submitted
- 22 Dec 2009
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holmqvist M, Vincent N, Walsh K. Web- vs. telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014 Feb;15(2):187-95. doi: 10.1016/j.sleep.2013.10.013. Epub 2013 Dec 31.
PubMed 24461370
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Cognitive-Behavioral Treatment for Insomnia Via Telehealth or Internet
- ClinicalTrials.gov ID
- NCT01162655
- Acronym / sponsor ID
- H2009:110
- Conditions
- Insomnia
- Keywords
- Insomnia, Cognitive-Behavioral Therapy, Internet, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Study start
- Apr 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive-Behavioural Therapy (CBT) is an effective treatment for chronic insomnia, which is a prevalent and costly problem. This pilot study will compare the effectiveness of two brief (6 week) psychological interventions delivered to residents of rural Manitoba using Telehealth or an interactive Internet-based platform. It is hypothesized that a) participants in the Telehealth condition will report significantly greater improvements in sleep parameters(e.g., sleep efficiency, time awake in bed, sleep-onset latency),insomnia severity, and daytime fatigue than those in the Internet condition and that b)participants in the Telehealth condition will show better adherence to treatment and greater satisfaction with treatment than those in the Internet condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Experimental | Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)Complete CBT group via telehealth |
| Internet | Experimental | Behavioral: Cognitive-behavioral therapy for Insomnia (CBT)Complete Internet-based CBT program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be residents of rural Manitoba (Canada)
- Must meet research diagnostic criteria for insomnia
- Must have access to a computer and high-speed internet
Key exclusion criteria (1 listed)
- Comorbid conditions (medical and psychiatric) must be stable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapy for Insomnia (CBT)6-week course of CBT delivered either using internet or telehealth | Behavioural | Internet, Telehealth |
Primary outcome
Insomnia Severity
Time frame: 6 weeks
The primary outcome measure will be insomnia severity, as assessed by the Insomnia Severity Index (ISI; Morin, 2003), a 6-item self-report measure of impairment due to sleep difficulties
1 secondary outcome
Sleep diary data
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 24461370Holmqvist M, Vincent N, Walsh K. Web- vs. telehealth-based delivery of cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Med. 2014 Feb;15(2):187-95. doi: 10.1016/j.sleep.2013.10.013. Epub 2013 Dec 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxine Holmqvist, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy for Insomnia (CBT) in people with Insomnia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.