Internet-based Cognitive Behavioral Therapy: a Factorial Randomized Controlled Trial About Treatment Content and Support

NCT ID: NCT06209541

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2026-04-30

Brief Summary

The purpose of this study is to investigate the differences in treatment outcomes between individually tailored and transdiagnostic internet-based cognitive behavioral therapy (ICBT), as well as the differences between weekly support by a specific therapist and weekly support by a team. The target group is adults (18 years or older) who experience mild to moderate depression symptoms, anxiety, stress or other psychological symptoms. The ICBT, in both types of treatment contents, consists of modules that the participants will work with for eight weeks in total. Participants will be recruited in Sweden with nationwide recruitment.

Detailed Description

This study is a factorial randomized controlled trial with the aim to investigate ICBT with two kinds of treatment contents and two kinds of support. Participants will either be randomized to an individually tailored treatment, where they will be selecting their own modules that they wish to work with, or be randomized to a transdiagnostic treatment, that consists of Unified Protocol that is developed by David Barlow and colleagues. Participants will also be randomized to either get weekly support by one specific therapist or get support by "a team", meaning that the participant will get support from different therapists each week. In both kinds of support, the participant will have the opportunity to ask for support during the other times of the week as well.

Primary outcome measures are depression symptoms (measured with Beck Depression Inventory-II) and anxiety symptoms (measured with Beck Anxiety Inventory). Other, secondary, outcome measures used will for example be about stress symptoms, insomnia symptoms, and quality of life. Pre-treatment measurement, post-treatment measurement and one-year follow up is planned to be collected through an online survey.

Conditions

Depression Symptoms; Anxiety Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unified Protocol, support by a specific therapist

The participants receive eight weeks of ICBT, based on the treatment manual Unified Protocol by David Barlow and colleagues (2013), with weekly support by a specific therapist that follow the individual participant through all treatment weeks. During the eight weeks, the participant will receive in total eight treatment modules.

Group Type: EXPERIMENTAL

Internet-based cognitive behavioral therapy (ICBT)

Intervention Type: BEHAVIORAL

All participants get treatment and are thus included in experimental groups, no matter the randomization result. It consists of eight treatment weeks with weekly support. The treatment format will differ between the four groups, depending on type of treatment content and type of support.

Unified Protocol, support by a team

The participants receive eight weeks of ICBT, based on the treatment manual Unified Protocol by David Barlow and colleagues (2013), with weekly support by a team of therapists. This arm implies that the participant will get support from different therapists each week. During the eight weeks, the participant will receive in total eight treatment modules.

Group Type: EXPERIMENTAL

Internet-based cognitive behavioral therapy (ICBT)

Intervention Type: BEHAVIORAL

All participants get treatment and are thus included in experimental groups, no matter the randomization result. It consists of eight treatment weeks with weekly support. The treatment format will differ between the four groups, depending on type of treatment content and type of support.

Individually tailored treatment, support by a specific therapist

The participants receive ICBT in an individually tailored format, where they get to select which modules they want to be included in their specific treatment. The participants are recommended to select eight modules (out of 25) and work with one modules each week, but this is only recommendations. In their treatment, weekly support by a specific therapist that follow the individual participant through all treatment weeks is included.

Group Type: EXPERIMENTAL

Internet-based cognitive behavioral therapy (ICBT)

Intervention Type: BEHAVIORAL

All participants get treatment and are thus included in experimental groups, no matter the randomization result. It consists of eight treatment weeks with weekly support. The treatment format will differ between the four groups, depending on type of treatment content and type of support.

Individually tailored treatment, support by team

The participants receive ICBT in an individually tailored format, where they get to select which modules they want to be included in their specific treatment. The participants are recommended to select eight modules (out of 25) and work with one modules each week, but this is only recommendations. In their treatment, weekly support by a team of therapists is included. This arm implies that the participant will get support from different therapists each week.

Group Type: EXPERIMENTAL

Internet-based cognitive behavioral therapy (ICBT)

Intervention Type: BEHAVIORAL

All participants get treatment and are thus included in experimental groups, no matter the randomization result. It consists of eight treatment weeks with weekly support. The treatment format will differ between the four groups, depending on type of treatment content and type of support.

Interventions

Internet-based cognitive behavioral therapy (ICBT)

All participants get treatment and are thus included in experimental groups, no matter the randomization result. It consists of eight treatment weeks with weekly support. The treatment format will differ between the four groups, depending on type of treatment content and type of support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Experience mild to moderate psychological symptoms or problems
• 18 years or older
• Ability to speak, read and write in Swedish
• Have access to the internet and a smartphone, computer or other device

Exclusion Criteria

• Severe psychiatric or somatic illness that makes participation harder or impossible
• Ongoing addiction
• Acute suicidality
• Other ongoing psychological treatment
• Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gerhard Andersson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerhard Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linkoeping

Locations

Linköping University

Linköping, , Sweden

Department of Behavioral Sciences and Learning

Linköping, Östergörland, Sweden

Countries

Sweden

Other Identifiers

INES

Identifier Type: -

Identifier Source: org_study_id