InsomniaPhase 3NCT01955850
Online or Face-to-face Treatment for Insomnia?
A Phase 3 study testing Cognitive behavioral treatment for insomnia in people with Insomnia, run by VU University of Amsterdam at 1 site in Netherlands.
Trial summary
The object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive behavioral treatment for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomnia disorder according to DSM-5
- Sleep onset latency/wake after sleep onset > 30 minutes , three times or more a week
- Insomnia three months or longer
- Access to internet
- Possibility to travel to one of the treatment sites
Who cannot join
- Earlier cognitive behavioral treatment for insomnia
- Start other psychological treatment in the last 6 months
- Doing shift work
- Major depression disorder
- Pregnancy or breast feeding
- Schizophrenia or psychosis
Show all 9Show fewer
- Suicidal plans
- Sleep apnea
- drugs or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Clinical Psychology
Amsterdam, North Holland, 1018XA
About this study
Official title: Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial
The object of this study is to compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.
- Conditions
- Insomnia
- Being tested
- Cognitive behavioral treatment for insomnia
- 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 treatment for insomniaBehavioural
Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT for insomnia | Experimental | Online Cognitive behavioral treatment for insomnia Receives: Behavioral: Cognitive behavioral treatment for insomnia |
| Face-to-face CBT for insomnia | Experimental | Face-to-face Cognitive behavioral treatment for insomnia Receives: Behavioral: Cognitive behavioral treatment for insomnia |
| Waiting-list | No intervention | Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Insomnia Severity Index
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Secondary outcomes (6)
Anxiety (HADS-A)
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related arousal measured with the Pre-arousal sleep scale
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep medication usage per day measured with the sleep diary
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Depression measured with the CES-D
Measured: Change from baseline to post-test, 3-months, and 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionApr 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Slaapmakend
- Responsible party
- Principal investigator, Jaap Lancee, VU University of Amsterdam
- Investigators
- Jaap Lancee, PhD, Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955850
- Sponsor's protocol ID
- UvA-2013-KP-3125
- Status last verified
- Dec 2014
- First submitted
- 20 Sep 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
Publications
Lancee J, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial. Behav Res Ther. 2012 Jan;50(1):22-9. doi: 10.1016/j.brat.2011.09.012. Epub 2011 Oct 24.
PubMed 22055281Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344.
PubMed 26414893
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online or Face-to-face Treatment for Insomnia? A Wait-list Controlled Trial
- ClinicalTrials.gov ID
- NCT01955850
- Acronym / sponsor ID
- UvA-2013-KP-3125
- Conditions
- Insomnia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Slaapmakend
- Study start
- Oct 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2013 (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 compare internet-delivered treatment for insomnia to face-to-face treatment and a waiting-list. In this study participants are randomized to: 1) online cognitive-behavioral intervention; 2) face-to-face cognitive behavioral intervention; 3) waiting-list. Both the online and face-to-face interventions consist of: diary; psycho-education; relaxation exercises; stimulus control/sleep hygiene; sleep restriction; challenging the misconceptions about sleep; and paradoxical exercise. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants fill out questionnaires and a dairy at baseline post-test, 3-month follow-up, and 6-month follow-up. Participants on the waiting-list receive online treatment after the first post-test. The investigators expect that the online-delivered treatment and the face-to-face treatment are equally effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT for insomnia | Experimental | Behavioral: Cognitive behavioral treatment for insomniaOnline Cognitive behavioral treatment for insomnia |
| Face-to-face CBT for insomnia | Experimental | Behavioral: Cognitive behavioral treatment for insomniaFace-to-face Cognitive behavioral treatment for insomnia |
| Waiting-list | No intervention | –Waiting-list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Insomnia disorder according to DSM-5
- Sleep onset latency/wake after sleep onset > 30 minutes , three times or more a week
- Insomnia three months or longer
- Access to internet
- Possibility to travel to one of the treatment sites
Key exclusion criteria (9 listed)
- Earlier cognitive behavioral treatment for insomnia
- Start other psychological treatment in the last 6 months
- Doing shift work
- Major depression disorder
- Pregnancy or breast feeding
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 treatment for insomniaCognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy. | Behavioural | Face-to-face CBT for insomnia, Internet-delivered CBT for insomnia |
Primary outcome
Sleep continuity (consisting of sleep latency, time awake after sleep onset, total sleep time)
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
For sleep continuity a 7-day sleep diary is used based on the consensus sleep diary.
Insomnia Severity Index
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
6 secondary outcomes
Anxiety (HADS-A)
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related worry measured with the Anxiety and Pre-occupation about Sleep Scale
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related arousal measured with the Pre-arousal sleep scale
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep related cognitions measured with the Dysfunctional Beliefs and Attitudes about sleep scale (DBAS)
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Sleep medication usage per day measured with the sleep diary
Time frame: Change from baseline to post-test, 3-months, and 6-months follow-up
Depression measured with the CES-D
Time frame: Change from baseline to post-test, 3-months, and 6-months 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 30 Dec 2014.
- Background: PubMed 22055281Lancee J, van den Bout J, van Straten A, Spoormaker VI. Internet-delivered or mailed self-help treatment for insomnia?: a randomized waiting-list controlled trial. Behav Res Ther. 2012 Jan;50(1):22-9. doi: 10.1016/j.brat.2011.09.012. Epub 2011 Oct 24.
- Derived from this study: PubMed 26414893Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344.
- General website for insomnia and used for the recruitmentLink 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, PhD principal investigator
University of Amsterdam
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 for insomnia in people with Insomnia, run by VU University of Amsterdam 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 5 inclusion and 9 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 Dec 2014. 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 continuity (consisting of sleep latency, time awake after sleep onset, total sleep time) (time frame: Change from baseline to post-test, 3-months, and 6-months follow-up). The study lists 2 primary outcomes in all. 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 NCT01955850, which also lists 2 linked publications.
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 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.