InsomniaIpsyInsomniNCT01256099
Internet-CBT for Insomnia
A study testing Therapist guided Internet-CBT for insomnia, Brief Internet-CBT for insomnia, without support and Therapist Guided Internet-CBT for depression in people with Insomnia and Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study includes two sub-trials. In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Therapist guided Internet-CBT for insomnia, Brief Internet-CBT for insomnia, without support and Therapist Guided Internet-CBT for depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Feb 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-IV-TR
- Enough language skills
- Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Who cannot join
- Sleep disorders requiring other treatment
- High consumption of alcohol/drugs that affect sleep
- Started to use or changed the dose of antidepressant drug during the last 2 months
- Somatic or psychiatric conditions requiring acute care
- Working night shifts
- Only Trial 1: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression
This study includes two sub-trials.
In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.
Read more
Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.
Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
- Conditions
- Insomnia, Depression
- Being tested
- Therapist guided Internet-CBT for insomnia, Brief Internet-CBT for insomnia, without support, Therapist Guided Internet-CBT for depression
- Keywords
- Self-help treatment, Internet treatment, CBT, Prevention, Comorbidity
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist guided Internet-CBT for insomniaBehavioural
An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
Brief Internet-CBT for insomnia, without supportBehavioural
No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
Therapist Guided Internet-CBT for depressionBehavioural
An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed
| Study group | Role | What they receive |
|---|---|---|
| Guided Internet-CBT for insomnia | Experimental | Not described Receives: Behavioral: Therapist guided Internet-CBT for insomnia |
| Control treatment | Placebo comparator | Not described Receives: Behavioral: Brief Internet-CBT for insomnia, without support |
| Guided Internet-CBT for insomnia (9) | Experimental | (9 weeks instead of 8) Receives: Behavioral: Therapist guided Internet-CBT for insomnia |
| Guided Internet-CBT for depression | Active comparator | Not described Receives: Behavioral: Therapist Guided Internet-CBT for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring insomnia severity. Bastien, C. H., Vallières, A., \& Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.
Measured: Post-treatment (9 weeks)
MADRS-S
The use of two primary outcomes are motivated since the purpose is to look at effects on both insomnia and depression. In trial 1 the former is used to predict the latter, and in Trial 2 the patientents suffer from both conditions.
The MADRS-S is a 9-item self-rated measure of depression severity and screens for suicidality.
Mattila-Evenden, M., Svanborg, P., Gustavsson, P., \& Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.
Measured: Post-treatment (9 weeks)
ISI
Measured: 6-month follow-up
ISI
Measured: 1-year follow-up
ISI
Measured: 3-years follow-up
MADRS-S
Measured: 6-month follow-up
MADRS-S
Measured: 1-year follow-up
MADRS-S
Measured: 3-years follow-up
Secondary outcomes (3)
Sleep Diary
One week of self-ratings on a number of sleep parameters, resluting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjecitve sleep quality and daytime functioning
Measured: Same as primary outcomes
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Health economic questionnaire evalutation cost for health care, abscence of work capacity and related costs.
Hakkaart-Van Roijen, L.,Van Straten, A., \& Donker, M. (2002). Manual: Trimbos/iMTA Questionnaire for Costs Associated with Psychiatric Illness. Rotterdam: Erasmus University
Measured: Same as Primary outcomes
EQ-5D
General quality of life measure to complement the TIC-P in health economic analysis.
Hinz, A., Klaiberg, A., Brahler, E., \& Konig, H.H. (2006). The Quality of Life Questionnaire EQ-5D: modelling and norm values for the general population. Psychother.Psychosom.Med.Psychol., 56, 42-48.
Measured: Same as primary outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256099
- Sponsor's protocol ID
- 2009/1810-31/3
- Acronym
- IpsyInsomni
- Status last verified
- Apr 2015
- First submitted
- 12 Oct 2010
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16.
PubMed 33813233Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up Comparing Cognitive Behavioral Therapy for Depression to Cognitive Behavioral Therapy for Insomnia, for Patients With Both Diagnoses. Sleep. 2017 Aug 1;40(8). doi: 10.1093/sleep/zsx108.
PubMed 28655183Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up of Insomnia and Hypnotics after Controlled Internet Treatment for Insomnia. Sleep. 2016 Jun 1;39(6):1267-74. doi: 10.5665/sleep.5850.
PubMed 27091535Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.
PubMed 25337948
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-treatment for Insomnia. Treatment Effects, Health Economics and Interaction With Depression
- ClinicalTrials.gov ID
- NCT01256099
- Acronym / sponsor ID
- IpsyInsomni / 2009/1810-31/3
- Conditions
- Insomnia, Depression
- Keywords
- Self-help treatment, Internet treatment, CBT, Prevention, Comorbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Jan 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Dec 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.
This study includes two sub-trials.
In trial 1 patients suffering from insomnia but not meeting the criteria for depression are randomised to either therapist guided Internet-based CBT for insomnia or to a control group with a non-guided, brief self-help program that acts as a placebo control. The primary purpose is to evaluate reduction in Insomnia severity (compared to placebo) after treatment and at follow-ups at 6-month, 1 year and 3 years. Secondary purpose is to evaluate the costeffectiveness of the treatment and to evaluate if the insomnia treatment has a preventive effect on future depressive episodes. Recruitment is done through mass media and includes all regions of Sweden. Initial assessment based on questionnaires and telephone interviews.
Trial 2 includes patients suffering from both Insomnia and depression. Randomization is done between either CBT for insomnia or CBT for depression (both Internet-based) to evaluate each respective treatment's effect on both insomnia and depression. The patients need for further treatment after the initial one will be measured and used as a secondary outcome. Recruitment is done through mass media but only citizens in the Stockholm area are included since the initial assessment are based on both questionnaires and telephone interviews as well as a visit at a psychiatrist located at the Internet psychiatry clinic in Stockholm.
Both trials will include health economic data and analysis. For the longer follow-up periods (1 and 3 years), registers will be used to analyse consumption of sleep medication and antidepressants as well as general health care utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Guided Internet-CBT for insomnia | Experimental | Behavioral: Therapist guided Internet-CBT for insomnia |
| Control treatment | Placebo comparator | Behavioral: Brief Internet-CBT for insomnia, without support |
| Guided Internet-CBT for insomnia (9) | Experimental | Behavioral: Therapist guided Internet-CBT for insomnia(9 weeks instead of 8) |
| Guided Internet-CBT for depression | Active comparator | Behavioral: Therapist Guided Internet-CBT for depression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical level of Insomnia (more than 10 on ISI)
- Meets criteria for Insomnia according to DSM-IV-TR
- Enough language skills
- Only Trial 2: Meets criteria for Major Depressive Disorder according to DSM-IV-TR
Key exclusion criteria (6 listed)
- Sleep disorders requiring other treatment
- High consumption of alcohol/drugs that affect sleep
- Started to use or changed the dose of antidepressant drug during the last 2 months
- Somatic or psychiatric conditions requiring acute care
- Working night shifts
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 |
|---|---|---|
| Therapist guided Internet-CBT for insomniaAn 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia | Behavioural | Guided Internet-CBT for insomnia, Guided Internet-CBT for insomnia (9) |
| Brief Internet-CBT for insomnia, without supportNo support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms | Behavioural | Control treatment |
| Therapist Guided Internet-CBT for depressionAn 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed | Behavioural | Guided Internet-CBT for depression |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Post-treatment (9 weeks)
7-item, self-rated questionnaire measuring insomnia severity. Bastien, C. H., Vallières, A., \& Morin, C. M. (2001). Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Medicine, 2, 297-307.
MADRS-S
Time frame: Post-treatment (9 weeks)
The use of two primary outcomes are motivated since the purpose is to look at effects on both insomnia and depression. In trial 1 the former is used to predict the latter, and in Trial 2 the patientents suffer from both conditions. The MADRS-S is a 9-item self-rated measure of depression severity and screens for suicidality. Mattila-Evenden, M., Svanborg, P., Gustavsson, P., \& Åsberg, M. (1996). Determinants of self-rating and expert rating concordance in psychiatric out-patients, using the affective subscales of CPRS. Acta Psychiatr Scand, 94, 386-396.
ISI
Time frame: 6-month follow-up
ISI
Time frame: 1-year follow-up
ISI
Time frame: 3-years follow-up
MADRS-S
Time frame: 6-month follow-up
MADRS-S
Time frame: 1-year follow-up
MADRS-S
Time frame: 3-years follow-up
3 secondary outcomes
Sleep Diary
Time frame: Same as primary outcomes
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: Same as Primary outcomes
EQ-5D
Time frame: Same as primary outcomes
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 3 Apr 2015.
- Derived from this study: PubMed 33813233Kraepelien M, Blom K, Forsell E, Hentati Isacsson N, Bjurner P, Morin CM, Jernelov S, Kaldo V. A very brief self-report scale for measuring insomnia severity using two items from the Insomnia Severity Index - development and validation in a clinical population. Sleep Med. 2021 May;81:365-374. doi: 10.1016/j.sleep.2021.03.003. Epub 2021 Mar 16.
- Derived from this study: PubMed 28655183Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up Comparing Cognitive Behavioral Therapy for Depression to Cognitive Behavioral Therapy for Insomnia, for Patients With Both Diagnoses. Sleep. 2017 Aug 1;40(8). doi: 10.1093/sleep/zsx108.
- Derived from this study: PubMed 27091535Blom K, Jernelov S, Ruck C, Lindefors N, Kaldo V. Three-Year Follow-Up of Insomnia and Hypnotics after Controlled Internet Treatment for Insomnia. Sleep. 2016 Jun 1;39(6):1267-74. doi: 10.5665/sleep.5850.
- Derived from this study: PubMed 25337948Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412.
- The public page of the Internet-CBT treatment platformLink 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 Therapist guided Internet-CBT for insomnia, Brief Internet-CBT for insomnia, without support and Therapist Guided Internet-CBT for depression in people with Insomnia and Depression, run by Karolinska Institutet 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 6 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 3 Apr 2015. 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. Some participants in this study may receive a placebo. 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) (time frame: Post-treatment (9 weeks)). The study lists 8 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 NCT01256099, which also lists 4 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 3 Apr 2015.