Clinical trial NCT01788657: iCBT for Depression - Standard Versus Condensed Treatment Material
Official title: Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: Depression
Internet
Cognitive Behavior Therapy
Lead sponsor: Örebro County Council
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2013-02-11
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in depressive symptoms at post-treatment and after 12 months
timeFrame: At baseline, after 12 weeks, after 12 months
Secondary outcomes:
measure: Change from baseline in diagnostic status for Major depression
timeFrame: Pre-treatment, after 12 weeks and after 1 year
measure: Change from baseline in symptoms of anxiety
timeFrame: Pre-treatment, after 12 weeks and after 1 year
measure: Post-treatment treatment satisfaction
timeFrame: After 12 weeks
measure: Therapist time
timeFrame: Post treatment
measure: Alcohol use
timeFrame: Pre treatment
measure: Drug use
timeFrame: Pre treatment
measure: Treatment satisfaction at follow up
timeFrame: After 1 year
Other outcomes:
measure: Reading speed
timeFrame: Pre treatment
measure: Ability to concentrate
timeFrame: Pre treatment
measure: Change from baseline in risk for suicide
timeFrame: After 1,2,3,4,5,6,7,8,9,10,11,12 weeks
Locations:
city: Örebro
country: Sweden
facility: Örebro County Council
state: Örebro County
Study officials:
affiliation: Örebro County Council
name: Fredrik Holländare, PhD
role: PRINCIPAL_INVESTIGATOR
References: