iCBT for Depression - Standard Versus Condensed Treatment Material

Not Applicable

Completed

• Conditions: Major Depression
• Interventions: Behavioral: Standard internet-based cognitive behavior therapy; Behavioral: Condensed internet-based cognitive behavior therapy

• Registration Number: NCT01788657
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Study Start: 2013-10-29
• Primary Completion: 2017-12-03
• Study Completion: 2017-12-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 273

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard internet-based cognitive behavior therapy	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).
Condensed internet-based cognitive behavior therapy	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline in depressive symptoms at post-treatment and after 12 months	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

Name	Time	Method
Treatment satisfaction at follow up	After 1 year	Treatment satisfaction at follow up will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Change from baseline in diagnostic status for Major depression	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.).
Change from baseline in symptoms of anxiety	Pre-treatment, after 12 weeks and after 1 year	Symptoms of anxiety will be conducted using the self-report measure Beck Anxiety Inventory (BAI)
Post-treatment treatment satisfaction	After 12 weeks	Post-treatment treatment satisfaction will be measured by the self-report measure Client Satisfaction Questionnaire (CSQ)
Therapist time	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.
Alcohol use	Pre treatment	To assess alkolhol use the AUDIT-questionnaire will be filled out at pre treatment.
Drug use	Pre treatment	To assess drug use the DUDIT-questionnaire will be filled out at pre treatment.

Trial Locations

Locations (1)

Örebro County Council; 🇸🇪 Örebro, Örebro County, Sweden