An interventional study of Standard internet-based cognitive behavior therapy and Condensed internet-based cognitive behavior therapy in Major Depression, sponsored by Örebro County Council. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by Örebro County Council · Not applicable, Interventional, and Treatment
Among 57 studies in Depressive Disorder, Major with a site in Sweden — 4 open to participants now, 6 under way, 2 of them phase 3. Depressive Disorder, Major · Sweden.
Among the 57 studies in Depressive Disorder, Major with a site in Sweden, this one is the 29th largest by enrollment of the 54 interventional ones that give a count, is one of 3 that started in 2013, is one of 16 with no phase, and was the 22nd registered.
3,046 studies on the registry are indexed under Depressive Disorder, Major; 592 are open to participants now.
Browse Depressive Disorder, Major studies →4 of the 57 studies in Depressive Disorder, Major with a site in Sweden are open now. Recruiting first, the newest first:
Neurocrine Biosciences · Sites in Sweden, United States, Australia and 20 more countries
Ages 18+
Janssen Research & Development, LLC · Sites in Sweden, United States, Argentina and 13 more countries
Ages 18–74
Linnaeus University · Sites in Sweden
Ages 15–18
Region Örebro County · Sites in Sweden
Ages 18+
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 412 Depressive Disorder, Major studies recruiting now, 93 (23%) set no upper age limit and 293 (71%) stop at 75 or younger; 55 take children under 18; 98 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
57 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 9 · Phase 3 24 · Phase 4 5
First in 2005; this study’s year is marked. 3 started in 2013.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 273 is above the median of 80 across 2,532 interventional studies indexed under Depressive Disorder, Major.
Median enrollment 322 across the 54 interventional studies, 2,173 across the 3 observational. Of the 50 that completed or were terminated, 15 (30%) have results posted.
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30 of 57 have an industry lead sponsor. The 10 most frequent:
Örebro County Council is the lead sponsor of 22 studies on the registry; none are open to participants now.
Örebro County Council has 2 studies filed under Depressive Disorder, Major — fewer than ten, so there is no comparison to draw.
2 of the studies in Depressive Disorder, Major with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06559306Phase 3Janssen Research & Development, LLCPhase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms | 2026-12-30 |
| NCT05575960Linnaeus UniversityInterpersonal Psychotherapy for Adolescents and Young Adults | 2026-12-31 |
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Among the 57 studies in Depressive Disorder, Major with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Internet-based cognitive behavior therapy (iCBT) has been shown effective for depression in several studies, however the investigators know very little about how the written treatment material should be designed to be effective and at the same time acceptable to the patients. The investigators are not aware of any research that has investigated if slow readers, or persons with difficulty concentrating, can use the standard material or if they would benefit more from using an adapted version.
In this study the investigators will assess reading speed and the ability to concentrate in all patients and then randomise them to an internet-based treatment for depression using either a standard material or a condensed one. The condensed material consists of 30000 words and will be available as text files and on audio files. The standard material consists of 60000 words and is only available as text files. Both groups will have the possibility of e-mail contact with a personal therapist during the treatment.
Patients will be recruited within Örebro County by referrals and self-referrals. The goal is to recruit between 200 and 300 patients during 2 years. The treatment time will be 10 weeks and all patients will be assessed for depression at an interview with a psychologist. There will also be interviews after treatment and one year after treatment. The most important outcome will be depressive symptoms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only).
Behavioral: Standard internet-based cognitive behavior therapy
Condensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio).
Behavioral: Condensed internet-based cognitive behavior therapy
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Also known as: Standard iCBT
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Also known as: Condensed iCBT
Change from baseline in depressive symptoms at post-treatment and after 12 months
Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated.
Time frame: At baseline, after 12 weeks, after 12 months
Change from baseline in diagnostic status for Major depression
The diagnostic status (depression) will be assessed in a face-to-face interview using the structured material Mini-International Neuropsychiatric Interview (M.I.N.I.).
Time frame: Pre-treatment, after 12 weeks and after 1 year
Change from baseline in symptoms of anxiety
Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)
Time frame: Pre-treatment, after 12 weeks and after 1 year
Post-treatment treatment satisfaction
Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Time frame: After 12 weeks
Therapist time
Therapist time will be measured automatically by the IT-platform and assesses the time spent on each patient by each therapist. A mean time will be calculated to report an estimated time needed to treat one patient with the two interventions.
Time frame: Post treatment
Alcohol use
To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.
Time frame: Pre treatment
Drug use
To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.
Time frame: Pre treatment
Treatment satisfaction at follow up
Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Time frame: After 1 year
Reading speed
To assess reading speed the "Diagnostiskt Läs och Skrivprov" (DLS) will be administered during the pre treatment interview.
Time frame: Pre treatment
Ability to concentrate
To assess the ability to concentrate six items from the WHO adult scale for attention deficit disorder (ASRS-VI.I) will be administered during the pre treatment interview.
Time frame: Pre treatment
Change from baseline in risk for suicide
Change in risk for suicide will be measured by item 9 in the MADRS-S every week
Time frame: After 1,2,3,4,5,6,7,8,9,10,11,12 weeks
Plan to share: Yes — Please contact us with suggestions for collaboration.
Supporting information: Study protocol, Informed consent form, Analytic code
Access criteria: Upon request
No publications or documents are linked to this record.
Ran from Oct 2013 to primary completion in Dec 2017, 49 months.
Of 648 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's 49 months is above that.
Counting every sponsor, half of 688 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Örebro County Council