iCBT for Depression - Standard Versus Condensed Treatment Material
KONRAD
Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version
1 other identifier
interventional
273
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2013
CompletedStudy Start
First participant enrolled
October 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 3, 2017
CompletedApril 5, 2023
March 1, 2023
4.1 years
February 1, 2013
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
At baseline, after 12 weeks, after 12 months
Secondary Outcomes (7)
Change from baseline in diagnostic status for Major depression
Pre-treatment, after 12 weeks and after 1 year
Change from baseline in symptoms of anxiety
Pre-treatment, after 12 weeks and after 1 year
Post-treatment treatment satisfaction
After 12 weeks
Therapist time
Post treatment
Alcohol use
Pre treatment
- +2 more secondary outcomes
Other Outcomes (3)
Reading speed
Pre treatment
Ability to concentrate
Pre treatment
Change from baseline in risk for suicide
After 1,2,3,4,5,6,7,8,9,10,11,12 weeks
Study Arms (2)
Standard internet-based cognitive behavior therapy
EXPERIMENTALStandard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only).
Condensed internet-based cognitive behavior therapy
EXPERIMENTALCondensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio).
Interventions
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Örebro County Councillead
- Karolinska Institutetcollaborator
Study Sites (1)
Örebro County Council
Örebro, Örebro County, 70116, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredrik Holländare, PhD
Örebro County Council
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
February 1, 2013
First Posted
February 11, 2013
Study Start
October 29, 2013
Primary Completion
December 3, 2017
Study Completion
December 3, 2017
Last Updated
April 5, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Access Criteria
- Upon request
Please contact us with suggestions for collaboration.