iCBT for Depression - Standard Versus Condensed Treatment Material

Major Depression Clinical Trial

— KONRAD  

Official title:

Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788657
• Other study ID #: Dnr 63:2012
• Status: Completed
• Phase: N/A
• Start date: October 29, 2013
• Est. completion date: December 3, 2017

Study information

• Verified date: March 2023
• Source: Örebro County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 3, 2017
• Est. primary completion date: December 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Behavioral:
• Standard internet-based cognitive behavior therapy
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
• Condensed internet-based cognitive behavior therapy
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention

Locations

Country	Name	City	State
Sweden	Örebro County Council	Örebro	Örebro County

Sponsors (2)

Lead Sponsor	Collaborator
Örebro County Council	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reading speed	To assess reading speed the "Diagnostiskt Läs och Skrivprov" (DLS) will be administered during the pre treatment interview.	Pre treatment
Other	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.	Pre treatment
Other	Change from baseline in risk for suicide	Change in risk for suicide will be measured by item 9 in the MADRS-S every week	After 1,2,3,4,5,6,7,8,9,10,11,12 weeks
Primary	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	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.).	Pre-treatment, after 12 weeks and after 1 year
Secondary	Change from baseline in symptoms of anxiety	Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)	Pre-treatment, after 12 weeks and after 1 year
Secondary	Post-treatment treatment satisfaction	Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)	After 12 weeks
Secondary	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.	Post treatment
Secondary	Alcohol use	To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.	Pre treatment
Secondary	Drug use	To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.	Pre treatment
Secondary	Treatment satisfaction at follow up	Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)	After 1 year