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Completed

NCT Number: NCT01788657

iCBT for Depression - Standard Versus Condensed Treatment Material

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.

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro County Council

Örebro, Örebro County, 70116, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard internet-based cognitive behavior therapy

Behavioral

Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention

Other names: Standard iCBT

Condensed internet-based cognitive behavior therapy

Behavioral

Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention

Other names: Condensed iCBT

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Örebro County Council

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: KONRAD

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2013
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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