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

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ClinicalTrials.gov Identifier: NCT01788657
Recruitment Status : Unknown
Verified February 2013 by Fredrik Holländare, Örebro County Council.
Recruitment status was:  Not yet recruiting
First Posted : February 11, 2013
Last Update Posted : February 11, 2013
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Fredrik Holländare, Örebro County Council

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.


Condition or disease Intervention/treatment Phase
Major Depression Behavioral: Standard internet-based cognitive behavior therapy Behavioral: Condensed internet-based cognitive behavior therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Internet-based Cognitive Behavior Therapy for Depression With Standard Treatment Material Compared to a Condensed Version
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Condensed iCBT




Primary Outcome Measures :
  1. Change from baseline in depressive symptoms at post-treatment and after 12 months [ Time Frame: At baseline, after 12 weeks, after 12 months ]
    Depressive symptoms will be measured by the self-report measure Montgomery-Åsberg Depression Rating Scale- self-rated.


Secondary Outcome Measures :
  1. Change from baseline in diagnostic status for Major depression [ Time Frame: Pre-treatment, after 12 weeks and after 1 year ]
    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.).

  2. Change from baseline in symptoms of anxiety [ Time Frame: Pre-treatment, after 12 weeks and after 1 year ]
    Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)

  3. Post-treatment treatment satisfaction [ Time Frame: After 12 weeks ]
    Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)

  4. Therapist time [ Time Frame: Post treatment ]
    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.

  5. Alcohol use [ Time Frame: Pre treatment ]
    To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.

  6. Drug use [ Time Frame: Pre treatment ]
    To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.

  7. Treatment satisfaction at follow up [ Time Frame: After 1 year ]
    Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)


Other Outcome Measures:
  1. Reading speed [ Time Frame: Pre treatment ]
    To assess reading speed the "Diagnostiskt Läs och Skrivprov" (DLS) will be administered during the pre treatment interview.

  2. Ability to concentrate [ Time Frame: Pre treatment ]
    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.

  3. Change from baseline in risk for suicide [ Time Frame: After 1,2,3,4,5,6,7,8,9,10,11,12 weeks ]
    Change in risk for suicide will be measured by item 9 in the MADRS-S every week



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788657


Contacts
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Contact: Fredrik Holländare, PhD +46737600700 fredrik.hollandare@orebroll.se

Locations
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Sweden
Örebro County Council Not yet recruiting
Örebro, Örebro County, Sweden, 70116
Contact: Fredrik Holländare, PhD    +46737600700    fredrik.hollandare@orebroll.se   
Sponsors and Collaborators
Örebro County Council
Karolinska Institutet
Investigators
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Principal Investigator: Fredrik Holländare, PhD Örebro County Council

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Responsible Party: Fredrik Holländare, PhD, Örebro County Council
ClinicalTrials.gov Identifier: NCT01788657     History of Changes
Other Study ID Numbers: Dnr 63:2012
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Fredrik Holländare, Örebro County Council:
Depression
Internet
Cognitive Behavior Therapy

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders