Major Depression
Conditions
Keywords
Depression, Internet, Cognitive Behavior Therapy
Brief summary
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.
Interventions
BEHAVIORALStandard internet-based cognitive behavior therapy
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
BEHAVIORALCondensed internet-based cognitive behavior therapy
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Sponsors
Karolinska Institutet
Örebro County Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fullfill criteria for diagnosis of major depression * Being able to read and write Swedish * Have access to the internet * Being a resident in Örebro county
Exclusion criteria
* Severe depressive symptoms (\>34 on the MADRS-S) * High risk for suicide * Attending cognitive behavior therapy * Psychosis * Bipolar disorder * Addiction to alcohol or illegal drugs * A somatic or psychiatric condition that is a contraindication for iCBT or in some way debars iCBT, or have to be treated before depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in depressive symptoms at post-treatment and after 12 months | At baseline, after 12 weeks, after 12 months | Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment treatment satisfaction | After 12 weeks | Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ) |
| Alcohol use | Pre treatment | To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment. |
| Drug use | Pre treatment | To assess drug use the DUDIT-questionnaire will be filled out at pre treatment. |
| Treatment satisfaction at follow up | After 1 year | Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ) |
| Change from baseline in diagnostic status for Major depression | Pre-treatment, after 12 weeks and after 1 year | 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.). |
| Change from baseline in symptoms of anxiety | Pre-treatment, after 12 weeks and after 1 year | Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI) |
| Therapist time | Post treatment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in risk for suicide | After 1,2,3,4,5,6,7,8,9,10,11,12 weeks | Change in risk for suicide will be measured by item 9 in the MADRS-S every week |
| Reading speed | Pre treatment | To assess reading speed the Diagnostiskt Läs och Skrivprov (DLS) will be administered during the pre treatment interview. |
| Ability to concentrate | Pre treatment | 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. |
Countries
Sweden
Outcome results
None listed