InsomniaPhase 3NCT01224912
Internet Delivered Self-Help CBT for Insomnia
A Phase 3 study testing Cognitive Behavioral Treatment in people with Insomnia, run by Utrecht University at 1 site in Netherlands.
Trial summary
The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Insomnia
- Access to the internet
Who cannot join
- Alcohol or substance abuse
- Being suicidal
- Sleep apnea
- Schizophrenic or having a psychosis disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention
The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Treatment
- Keywords
- Insomnia, Intervention, Self-help, Internet
- 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 TreatmentBehavioural
The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).
| Study group | Role | What they receive |
|---|---|---|
| Internet Deliviered CBT for Insomnia | Experimental | Cognitive behavioral self-help method for insomnia via the Internet Receives: Behavioral: Cognitive Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Measured: baseline
Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Measured: 4-week follow-up
Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Measured: 18-week follow-up
Sleep diary
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Measured: 48-week follow-up
Secondary outcomes (16)
Anxiety
Measured with the HADS
Measured: Baseline
Anxiety
HADS
Measured: 4-week follow-up
Anxiety
HADS
Measured: 18-week follow-up
Anxiety
HADS
Measured: 48-week follow-up
Depression
CES-D
Measured: Baseline
Depression
CES-D
Measured: 4 week follow-up
Depression
CES-D
Measured: 18-week follow-up
Depression
CES-D
Measured: 48-week follow-up
Sleep medication
Sleep medication as measured by the sleep diary
Measured: Baseline
Sleep medication
Sleep medication as measured by the sleep diary
Measured: 4-week follow-up
Sleep medication
Sleep medication as measured by the sleep diary
Measured: 18-week follow-up
Sleep medication
Sleep medication as measured by the sleep diary
Measured: 48-week follow-up
Insomnia Severity
Insomnia Severity Index
Measured: Baseline
Insomnia severity
Insomnia Severity Index
Measured: four-week follow-up
Insomnia severity
Insomnia Severity Index
Measured: 18-week follow-up
Insomnia severity
Insomnia Severity Index
Measured: 48-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht University
- Sponsor type
- University, hospital or other
- Investigators
- Jaap Lancee, MSc, Principal investigator, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224912
- Sponsor's protocol ID
- UU-vandenBout-2
- Status last verified
- Jan 2013
- First submitted
- 18 Oct 2010
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention
- ClinicalTrials.gov ID
- NCT01224912
- Acronym / sponsor ID
- UU-vandenBout-2
- Conditions
- Insomnia
- Keywords
- Insomnia, Intervention, Self-help, Internet
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Utrecht UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Oct 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.
The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet Deliviered CBT for Insomnia | Experimental | Behavioral: Cognitive Behavioral TreatmentCognitive behavioral self-help method for insomnia via the Internet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Insomnia
- Access to the internet
Key exclusion criteria (4 listed)
- Alcohol or substance abuse
- Being suicidal
- Sleep apnea
- Schizophrenic or having a psychosis disorder
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 TreatmentThe techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow). | Behavioural | Internet Deliviered CBT for Insomnia |
Primary outcome
Sleep diary
Time frame: baseline
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
Time frame: 4-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
Time frame: 18-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
Time frame: 48-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
16 secondary outcomes
Anxiety
Time frame: Baseline
Anxiety
Time frame: 4-week follow-up
Anxiety
Time frame: 18-week follow-up
Anxiety
Time frame: 48-week follow-up
Depression
Time frame: Baseline
Depression
Time frame: 4 week follow-up
Depression
Time frame: 18-week follow-up
Depression
Time frame: 48-week follow-up
Sleep medication
Time frame: Baseline
Sleep medication
Time frame: 4-week follow-up
Sleep medication
Time frame: 18-week follow-up
Sleep medication
Time frame: 48-week follow-up
Insomnia Severity
Time frame: Baseline
Insomnia severity
Time frame: four-week follow-up
Insomnia severity
Time frame: 18-week follow-up
Insomnia severity
Time frame: 48-week follow-up
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 8 Jan 2013.
- Popular scientific website about insomniaLink provided by the sponsor.
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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.
Jaap Lancee, MSc principal investigator
Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Treatment in people with Insomnia, run by Utrecht University at 1 site in Netherlands.
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 2 inclusion and 4 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 8 Jan 2013. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sleep diary (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2013.