iCBT for Depression - Standard Versus Condensed Treatment Material

NCT ID: NCT01788657

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-29

Study Completion Date

2017-12-03

Brief Summary

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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

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

Standard internet-based cognitive behavior therapy

Intervention Type BEHAVIORAL

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

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).

Group Type EXPERIMENTAL

Condensed internet-based cognitive behavior therapy

Intervention Type BEHAVIORAL

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

Interventions

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Standard internet-based cognitive behavior therapy

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

Intervention Type BEHAVIORAL

Condensed internet-based cognitive behavior therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Standard iCBT Condensed iCBT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Örebro County Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fredrik Holländare

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fredrik Holländare, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro County Council

Locations

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Örebro County Council

Örebro, Örebro County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr 63:2012

Identifier Type: -

Identifier Source: org_study_id

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