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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Behavioral: Standard internet-based cognitive behavior therapy; Behavioral: Condensed internet-based cognitive behavior therapy

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro County
    • Örebro, Örebro County, Sweden, 70116
      • Örebro County Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard internet-based cognitive behavior therapy; 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; Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention; Other Names: Standard iCBT
Experimental: Condensed 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; Other Names: Condensed iCBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Post-treatment treatment satisfaction	Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)	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.	Post treatment
Alcohol use	To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.	Pre treatment
Drug use	To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.	Pre treatment
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading speed	To assess reading speed the "Diagnostiskt Läs och Skrivprov" (DLS) will be administered during the pre treatment interview.	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.	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	After 1,2,3,4,5,6,7,8,9,10,11,12 weeks

Collaborators and Investigators

• Sponsor: Örebro County Council
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Fredrik Holländare, PhD, Örebro County Council

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2013
• Primary Completion (Actual): December 3, 2017
• Study Completion (Actual): December 3, 2017

Study Registration Dates

• First Submitted: February 1, 2013
• First Submitted That Met QC Criteria: February 7, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Internet; Cognitive Behavior Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: Dnr 63:2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Please contact us with suggestions for collaboration.
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE