DyssomniasNCT02612987
iCBT for Adolescents With Co-morbid Insomnia
A study testing Internet-based Cognitive Behaviour Therapy (iCBT) in people with Dyssomnias, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment of insomnia has been extensively examined in adults, but studies with adolescents are sparse. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Dyssomnias
- What is being tested?
- Internet-based Cognitive Behaviour Therapy (iCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to Oct 2017
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- To fulfill the diagnostic criteria for insomnia
- To have access to a computer with Internet connection
- No previous or ongoing CBT for insomnia
- No psychotropic medication or being on a stable dosage for at least six weeks before enrollment
Who cannot join
- Ongoing manic or psychotic episode
- Being at high risk of triggering manic or psychotic episode
- Ongoing sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia Attending Children and Youth Psychiatry: An Open Trial
Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment of insomnia has been extensively examined in adults, but studies with adolescents are sparse. The purpose of this pilot study is to assess the feasibility and efficacy of internet-based cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly assessments will also be made during treatment on primary outcome and a presumed process variable constructed for the purpose of this trial.
- Conditions
- Dyssomnias
- Being tested
- Internet-based Cognitive Behaviour Therapy (iCBT)
- Keywords
- CBT, Internet based
- Medical subject headings
- Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Cognitive Behaviour Therapy (iCBT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| iCBT | Experimental | Not described Receives: Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI; Morin, 1993)
Given that this is an intervention study we are assessing changes in outcome over time.
Measured: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Secondary outcomes (3)
The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)
Given that this is an intervention study we are assessing changes in outcome over time.
Measured: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Symptoms Checklist (SCL-90; Derogatis et al., 1994)
Given that this is an intervention study we are assessing changes in outcome over time.
Measured: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
Given that this is an intervention study we are assessing changes in outcome over time.
Measured: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyssomniasStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University
- Responsible party
- Principal investigator, Vendela Zetterqvist, Uppsala University Hospital
- Investigators
- Vendela Zetterqvist, Ph D, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612987
- Sponsor's protocol ID
- 2015/326
- Status last verified
- Mar 2018
- First submitted
- 15 Nov 2015
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia Attending Children and Youth Psychiatry: An Open Trial
- ClinicalTrials.gov ID
- NCT02612987
- Acronym / sponsor ID
- 2015/326
- Conditions
- Dyssomnias
- Keywords
- CBT, Internet based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 24 Nov 2015 (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.
Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment of insomnia has been extensively examined in adults, but studies with adolescents are sparse. The purpose of this pilot study is to assess the feasibility and efficacy of internet-based cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly assessments will also be made during treatment on primary outcome and a presumed process variable constructed for the purpose of this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCBT | Experimental | Behavioral: Internet-based Cognitive Behaviour Therapy (iCBT) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- To fulfill the diagnostic criteria for insomnia
- To have access to a computer with Internet connection
- No previous or ongoing CBT for insomnia
- No psychotropic medication or being on a stable dosage for at least six weeks before enrollment
Key exclusion criteria (3 listed)
- Ongoing manic or psychotic episode
- Being at high risk of triggering manic or psychotic episode
- Ongoing sleep apnea
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-based Cognitive Behaviour Therapy (iCBT) | Behavioural | iCBT |
Primary outcome
Insomnia Severity Index (ISI; Morin, 1993)
Time frame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Given that this is an intervention study we are assessing changes in outcome over time.
3 secondary outcomes
The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)
Time frame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Symptoms Checklist (SCL-90; Derogatis et al., 1994)
Time frame: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
Time frame: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month 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 5 Mar 2018.
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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.
Vendela Zetterqvist, Ph D principal investigator
Uppsala University Hospital
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-based Cognitive Behaviour Therapy (iCBT) in people with Dyssomnias, run by Uppsala University Hospital at 1 site in Sweden.
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 4 inclusion and 3 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 5 Mar 2018. 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 Sweden. 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 Index (ISI; Morin, 1993) (time frame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up). 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 5 Mar 2018.