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iCBT for Depression - Standard Versus Condensed Treatment Material (KONRAD)

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Standard internet-based cognitive behavior therapy
Condensed internet-based cognitive behavior therapy
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Depression, Internet, Cognitive Behavior Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Örebro County Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard internet-based cognitive behavior therapy

Condensed internet-based cognitive behavior therapy

Arm Description

Standard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only).

Condensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.).
Change from baseline in symptoms of anxiety
Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)
Post-treatment treatment satisfaction
Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
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.
Alcohol use
To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.
Drug use
To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.
Treatment satisfaction at follow up
Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)

Full Information

First Posted
February 1, 2013
Last Updated
March 31, 2023
Sponsor
Örebro County Council
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01788657
Brief Title
iCBT for Depression - Standard Versus Condensed Treatment Material
Acronym
KONRAD
Official Title
Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 29, 2013 (Actual)
Primary Completion Date
December 3, 2017 (Actual)
Study Completion Date
December 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Depression, Internet, Cognitive Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard internet-based cognitive behavior therapy
Arm Type
Experimental
Arm Description
Standard internet-based cognitive behavior therapy for depression with a written treatment material consisting of 60000 words (textmaterial only).
Arm Title
Condensed internet-based cognitive behavior therapy
Arm Type
Experimental
Arm Description
Condensed internet-based cognitive behavior therapy for depression with a written treatment material consisting of 30000 words (available as text or audio).
Intervention Type
Behavioral
Intervention Name(s)
Standard internet-based cognitive behavior therapy
Other Intervention Name(s)
Standard iCBT
Intervention Description
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Intervention Type
Behavioral
Intervention Name(s)
Condensed internet-based cognitive behavior therapy
Other Intervention Name(s)
Condensed iCBT
Intervention Description
Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
Primary Outcome Measure Information:
Title
Change from baseline in depressive symptoms at post-treatment and after 12 months
Description
Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated.
Time Frame
At baseline, after 12 weeks, after 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in diagnostic status for Major depression
Description
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.).
Time Frame
Pre-treatment, after 12 weeks and after 1 year
Title
Change from baseline in symptoms of anxiety
Description
Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)
Time Frame
Pre-treatment, after 12 weeks and after 1 year
Title
Post-treatment treatment satisfaction
Description
Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Time Frame
After 12 weeks
Title
Therapist time
Description
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.
Time Frame
Post treatment
Title
Alcohol use
Description
To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.
Time Frame
Pre treatment
Title
Drug use
Description
To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.
Time Frame
Pre treatment
Title
Treatment satisfaction at follow up
Description
Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Time Frame
After 1 year
Other Pre-specified Outcome Measures:
Title
Reading speed
Description
To assess reading speed the "Diagnostiskt Läs och Skrivprov" (DLS) will be administered during the pre treatment interview.
Time Frame
Pre treatment
Title
Ability to concentrate
Description
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.
Time Frame
Pre treatment
Title
Change from baseline in risk for suicide
Description
Change in risk for suicide will be measured by item 9 in the MADRS-S every week
Time Frame
After 1,2,3,4,5,6,7,8,9,10,11,12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Holländare, PhD
Organizational Affiliation
Örebro County Council
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro County Council
City
Örebro
State/Province
Örebro County
ZIP/Postal Code
70116
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Please contact us with suggestions for collaboration.
IPD Sharing Access Criteria
Upon request

Learn more about this trial

iCBT for Depression - Standard Versus Condensed Treatment Material

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