InsomniaNCT00851188
Internet Delivered Self-help for Insomnia
A study testing Internet CBT self-help, CBT self-help booklet and Waiting list in people with Insomnia, run by Jaap Lancee at 1 site in Netherlands.
Trial summary
The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. 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?
- Internet CBT self-help, CBT self-help booklet and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2009to Apr 2010
- 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 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
- Severe depression
- Being suicidal
- Sleep apnea
- Schizophrenic or having a psychosis disorder
Trial locations and contacts
1 site in 1 country.
About this study
The current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
- Conditions
- Insomnia
- Being tested
- Internet CBT self-help, CBT self-help booklet, Waiting list
- 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.
Internet CBT self-helpBehavioural
Internet based Cognitive behavioral self-help method for insomnia
CBT self-help bookletBehavioural
Cognitive behavioral self-help method for insomnia via booklet
Waiting listOther
Waiting list
| Study group | Role | What they receive |
|---|---|---|
| internet CBT self-help | Experimental | CBT via the internet Receives: Behavioral: Internet CBT self-help |
| CBT self-help booklet | Experimental | Not described Receives: Behavioral: CBT self-help booklet |
| Waiting list | Active comparator | Not described Receives: Other: Waiting list |
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: 1 year
Secondary outcomes (3)
Anxiety rating
Measured with the HADS
Measured: 1 year
Depression ratings
Measured with the CES-D
Measured: 1 year
Sleep medication
Measured in the daily diary log
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionApr 2010
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaap Lancee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaap Lancee, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851188
- Sponsor's protocol ID
- UU-vandenBout
- Status last verified
- Jun 2012
- First submitted
- 24 Feb 2009
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Self-help for Insomnia
- ClinicalTrials.gov ID
- NCT00851188
- Acronym / sponsor ID
- UU-vandenBout
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Jaap LanceeUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 25 Feb 2009 (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 current study aims to evaluate the effects of internet-delivered self-help CBT for insomnia through a randomised controlled trial. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be randomised into treatment groups or the waiting list. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| internet CBT self-help | Experimental | Behavioral: Internet CBT self-helpCBT via the internet |
| CBT self-help booklet | Experimental | Behavioral: CBT self-help booklet |
| Waiting list | Active comparator | Other: Waiting list |
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 (5 listed)
- Alcohol or substance abuse
- Severe depression
- 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 |
|---|---|---|
| Internet CBT self-helpInternet based Cognitive behavioral self-help method for insomnia | Behavioural | internet CBT self-help |
| CBT self-help bookletCognitive behavioral self-help method for insomnia via booklet | Behavioural | CBT self-help booklet |
| Waiting listWaiting list | Other | Waiting list |
Primary outcome
Sleep Diary
Time frame: 1 year
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
3 secondary outcomes
Anxiety rating
Time frame: 1 year
Depression ratings
Time frame: 1 year
Sleep medication
Time frame: 1 year
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 13 Jun 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet CBT self-help, CBT self-help booklet and Waiting list in people with Insomnia, run by Jaap Lancee 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 5 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 13 Jun 2012. 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.
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: 1 year). 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 13 Jun 2012.