InsomniaNCT01663844

New Clinical Applications for Internet-based Cognitive Behavior Therapy for Insomnia and Depression

A study testing Therapist guided Internet-CBT for insomnia w. extra support, Therapist guided Internet-CBT for insomnia and Therapist guided Internet-CBT for insomnia and depression in people with Insomnia and Major Depression, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study includes two sub-trials. Both are included in this singe registration since they have parallel inclusion of participants and have been approved by the Swedish ethics board together in one application. Trial 1 includes patients with both insomnia and major or minor depression. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Insomnia, Major Depression, Minor Depression
What is being tested?: Therapist guided Internet-CBT for insomnia w. extra support, Therapist guided Internet-CBT for insomnia and Therapist guided Internet-CBT for insomnia and depression
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 440 participants
Where: 1 siteSweden
Study dates: Jan 2013to May 2022
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 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required).

Who cannot join

Sleep disorders requiring other treatment
Alcohol/drugs abuse
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 2: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required for exclusion).

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Internetpsykiatrienheten (Internet Psychiatry Clinic) Psykiatri Sydväst, SLSO
Stockholm, S-14186

Other trials in Sweden

About this study

Official title: New Clinical Applications for Internet-based Cognitive Behavior Therapy: An Adaptive Treatment Strategy to Decrease the Number of Failed Treatments, and a Combination Treatment for Insomnia and Depression.

Trial 1 includes patients with both insomnia and major or minor depression. Participants are randomized to either a combined therapist guided Internet-CBT for insomnia and depression, or to Internet-CBT for depression with an addition of a placebo intervention for insomnia. The primary purpose is to evaluate changes in insomnia and depression severity for the combination treatment compared to the depression treatment, after treatment and at 6 and 36 months follow up. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.

Trial 2 includes patients with insomnia who do not meet criteria for major or minor depression. All participants start therapist guided Internet-CBT for insomnia. After 4 weeks patients that are judged to be at risk of treatment failure are randomized to either continued treatment or treatment with added support intended to enhance outcome. The primary purpose is to evaluate change in insomnia severity for participants who get added support, compared to continued treatment with regular support level. A secondary purpose is to evaluate cognitive functioning before and after treatment, as well as cost effectiveness. Recruitment is done in the Stockholm County through mass media and the Internet psychiatry clinic's regular patient recruitment.

NOTE:

The first participants in trial 1 will be regarded as pilots, due to problems with the experimental treatment: technical issues as well as problems with the design of treatment modules. These problems were corrected when discovered. 12 participants in the experimental arm were affected by these errors. The pilot participants will not be included in the main analyses of data. This was decided upon on 31st of October 2014.

Conditions: Insomnia, Major Depression, Minor Depression
Being tested: Therapist guided Internet-CBT for insomnia w. extra support, Therapist guided Internet-CBT for insomnia, Therapist guided Internet-CBT for insomnia and depression, Therapist Guided Internet-CBT for depression plus insomnia placebo
Keywords: Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, Depression, ICBT, CBT-i, CBT-d
Medical subject headings: Sleep Initiation and Maintenance Disorders, Depressive Disorder, Major, 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 insomnia w. extra supportBehavioural
(Study 2) A 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 insomnia plus extra therapist support.
Therapist guided Internet-CBT for insomniaBehavioural
(Study 2) A 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 insomnia. Regular therapist support.
Therapist guided Internet-CBT for insomnia and depressionBehavioural
(Study 1) A 12 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 and depression.
Therapist Guided Internet-CBT for depression plus insomnia placeboBehavioural
(Study 1) A 12 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. A placebo intervention for insomnia is added.

Study groups in NCT01663844
Study group	Role	What they receive
(Study 1) ICBT for insomnia and depression	Experimental	Not described Receives: Behavioral: Therapist guided Internet-CBT for insomnia and depression
(Study 1) ICBT for depr. plus placebo insomnia intervention	Active comparator	Not described Receives: Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo
(Study 2) ICBT for insomnia with added support	Experimental	Not described Receives: Behavioral: Therapist guided Internet-CBT for insomnia w. extra support
(Study 2) ICBT for insomnia with regular level of support	Active comparator	Not described Receives: Behavioral: Therapist guided Internet-CBT for insomnia

What is being measured

The primary outcome is the main question the study is designed to answer.

Change (from baseline) in Insomnia Severity Index (ISI)
7-item, self-rated questionnaire measuring change in 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: 0, 6 and 36 months after treatment
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
Defined as secondary outcome measure in Trial 2. The use of two primary outcomes in trial 1 is motivated since participants have both diagnoses and the purpose is to look at effects on both insomnia and depression.
The MADRS-S is a 9-item self-rated measure of change in depression severity. It also 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: 0, 6 and 36 months after treatment

Secondary outcomes (7)

Change (from baseline) in Sleep Diary
One week of self-ratings on a number of sleep parameters, resulting in measures of sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings, subjective sleep quality and daytime functioning.
Measured: Directly after treatment
Changes (from baseline) in Actigraph data
An actigraph is placed on the participant's arm for one week. They measure participants' activity in the form of movements. It will be used for acquiring sleep data and calculate sleep latency, total sleep time, sleep efficacy, number of nighttime awakenings and daytime activity.
Measured: Directly post treatment
Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Health economic questionnaire evaluation cost for health care, absence 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: 0, 6 and 36 months after treatment
Change (from baseline) in Cognitive functioning
Computer based testing of executive functions, concentration, speed and memory.
Measured: Directly at post-treatment
Change (from baseline) in EuroQuol. 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: 0, 6 and 36 months after treatment
Change (from baseline) in Sheehan Disability Scale
Measures daily life functioning. Sheehan, D. V. (1983). The Anxiety disease. Scribner: New York
Measured: 0, 6 and 36 months after treatment
Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM
Measures psychological health in general. Evans, C., Connell, J., Barkham, M., Margison, F., McGrath, G., Mellor-Clark, J. \& Audin, K. (2002). Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. The British journal of psychiatry : the journal of mental science 180, 51-60.
Measured: 0, 6 and 36 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013May 2022

First posted13 Aug 2012 (estimated)
Study startJan 2013
Primary completionDec 2018
Study completionMay 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 440 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01663844
Sponsor's protocol ID: 2012/934-31/4
Status last verified: Jul 2022
First submitted: 3 Aug 2012
Last updated: 18 Jul 2022
Results posted: No
Data monitoring committee: No

Publications

Tamm S, Jernelov S, Forsell E, Eldh A, Hallek de Oliveira A, Maurex L, Kaldo V, Blom K. Objectively measured cognitive function in insomnia patients with and without comorbid depression treated with cognitive behavioral therapy for insomnia. BMC Psychiatry. 2025 Oct 2;25(1):916. doi: 10.1186/s12888-025-07460-5.
PubMed 41039374
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 33813233
Forsell E, Jernelov S, Blom K, Kraepelien M, Svanborg C, Andersson G, Lindefors N, Kaldo V. Proof of Concept for an Adaptive Treatment Strategy to Prevent Failures in Internet-Delivered CBT: A Single-Blind Randomized Clinical Trial With Insomnia Patients. Am J Psychiatry. 2019 Apr 1;176(4):315-323. doi: 10.1176/appi.ajp.2018.18060699. Epub 2019 Jan 30.
PubMed 30696270

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: New Clinical Applications for Internet-based Cognitive Behavior Therapy: An Adaptive Treatment Strategy to Decrease the Number of Failed Treatments, and a Combination Treatment for Insomnia and Depression.
ClinicalTrials.gov ID: NCT01663844
Acronym / sponsor ID: 2012/934-31/4
Conditions: Insomnia, Major Depression, Minor Depression
Keywords: Cognitive behavior therapy, Internet treatment, Self-help treatment, Insomnia, Depression, ICBT, CBT-i, CBT-d
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (estimated)
Lead sponsor: Karolinska InstitutetUniversity, hospital or other
Collaborators: Region Stockholm
Study start: Jan 2013 (actual)
Primary completion: Dec 2018 (actual)
Study completion: May 2022 (actual)
First posted: 13 Aug 2012 (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.

NOTE:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
(Study 1) ICBT for insomnia and depression	Experimental	Behavioral: Therapist guided Internet-CBT for insomnia and depression
(Study 1) ICBT for depr. plus placebo insomnia intervention	Active comparator	Behavioral: Therapist Guided Internet-CBT for depression plus insomnia placebo
(Study 2) ICBT for insomnia with added support	Experimental	Behavioral: Therapist guided Internet-CBT for insomnia w. extra support
(Study 2) ICBT for insomnia with regular level of support	Active comparator	Behavioral: Therapist guided Internet-CBT for insomnia

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 1: Meets criteria for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required).

Key exclusion criteria (6 listed)

Sleep disorders requiring other treatment
Alcohol/drugs abuse
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 insomnia w. extra support(Study 2) A 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 insomnia plus extra therapist support.	Behavioural	(Study 2) ICBT for insomnia with added support
Therapist guided Internet-CBT for insomnia(Study 2) A 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 insomnia. Regular therapist support.	Behavioural	(Study 2) ICBT for insomnia with regular level of support
Therapist guided Internet-CBT for insomnia and depression(Study 1) A 12 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 and depression.	Behavioural	(Study 1) ICBT for insomnia and depression
Therapist Guided Internet-CBT for depression plus insomnia placebo(Study 1) A 12 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. A placebo intervention for insomnia is added.	Behavioural	(Study 1) ICBT for depr. plus placebo insomnia intervention

Primary outcome

Change (from baseline) in Insomnia Severity Index (ISI)
Time frame: 0, 6 and 36 months after treatment
7-item, self-rated questionnaire measuring change in 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.
Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S
Time frame: 0, 6 and 36 months after treatment
Defined as secondary outcome measure in Trial 2. The use of two primary outcomes in trial 1 is motivated since participants have both diagnoses and the purpose is to look at effects on both insomnia and depression. The MADRS-S is a 9-item self-rated measure of change in depression severity. It also 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.

7 secondary outcomes

Change (from baseline) in Sleep Diary
Time frame: Directly after treatment
Changes (from baseline) in Actigraph data
Time frame: Directly post treatment
Change (from baseline) in Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Cognitive functioning
Time frame: Directly at post-treatment
Change (from baseline) in EuroQuol. EQ-5D
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Sheehan Disability Scale
Time frame: 0, 6 and 36 months after treatment
Change (from baseline) in Clinical Outcome in Routine Evaluation - 10, CORE-OM
Time frame: 0, 6 and 36 months after treatment

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 18 Jul 2022.
Derived from this study: PubMed 41039374Tamm S, Jernelov S, Forsell E, Eldh A, Hallek de Oliveira A, Maurex L, Kaldo V, Blom K. Objectively measured cognitive function in insomnia patients with and without comorbid depression treated with cognitive behavioral therapy for insomnia. BMC Psychiatry. 2025 Oct 2;25(1):916. doi: 10.1186/s12888-025-07460-5.
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 30696270Forsell E, Jernelov S, Blom K, Kraepelien M, Svanborg C, Andersson G, Lindefors N, Kaldo V. Proof of Concept for an Adaptive Treatment Strategy to Prevent Failures in Internet-Delivered CBT: A Single-Blind Randomized Clinical Trial With Insomnia Patients. Am J Psychiatry. 2019 Apr 1;176(4):315-323. doi: 10.1176/appi.ajp.2018.18060699. Epub 2019 Jan 30.
The public page of the Internet Psychiatry ClinicLink 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.

Viktor Kaldo, PhD principal investigator

Karolinska Institutet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 Jul 2022. 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?

Change (from baseline) in Insomnia Severity Index (ISI) (time frame: 0, 6 and 36 months after treatment). 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 NCT01663844, which also lists 3 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 18 Jul 2022.