ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content

Linköping University (LiU)

Status: Completed

Conditions: Depressive Symptoms; Depressive Disorder, Major

Treatments: Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04260750

LUNA

Details and patient eligibility

About

The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.

Full description

The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.

Enrollment: 246 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
• 18 years or older.
• Adequate ability to understand and speak Swedish.
• Access to the internet and a smartphone/computer.

Exclusion criteria

• Other ongoing psychological treatment or counselling.
• Recent (within the past 3 months) changes in the dose of psychotropic medication.
• Prior diagnosis of psychosis, bipolar disorder, or substance dependence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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246 participants in 4 patient groups

Expert-chosen content, regular guidance

Experimental group

Description:

Content chosen by the therapist, weekly guidance by a therapist.

Treatment:

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Expert-chosen content, on-demand guidance

Experimental group

Description:

Content chosen by the therapist, guidance upon request from the health care team.

Treatment:

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Participant-chosen content, regular guidance

Experimental group

Description:

Content chosen by participants themselves, weekly guidance by a therapist.

Treatment:

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)

Participant-chosen content, on-demand guidance

Experimental group

Description:

Content chosen by participants themselves, guidance upon request from the health care team.

Treatment:

Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)