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

NCT06209541 | Active Not Recruiting

• 1 other identifier: INES
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression Symptoms; Anxiety Symptoms

Keywords

Internet-based cognitive behavioral therapy (ICBT); Internet intervention; Depression; Anxiety; Individually tailored; Transdiagnostic; Alliance

Outcome Measures

Primary Outcomes (2)

• Becks Depression Inventory-II

  Measure of depressive symptoms. Range for the total sum is between 0 and 63 with a higher score indicating a higher level of depressive symptoms. Clinical ranges for minimal, mild, moderate and severe major depressive disorder are considered to be 0-13, 13-19, 20-28, and 29-63 points respectively.

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Beck Anxiety Inventory

  Measure of anxiety symptoms, consisting of 21 items. Range for the total sum is between 0 and 63, interpreted as minimal anxiety (0-7), mild anxiety (8-15), moderate anxiety (16-25) and severe anxiety (26-63).

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Secondary Outcomes (8)

• Perceived Stress Scale-14

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Insomnia Severity Index

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Alcohol Use Disorder Identification Test

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Brunnsviken Brief Quality of Life Scale

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

• Patient Health Questionnaire-15

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Other Outcomes (1)

• Knowledge test (created by the research team)

  Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.

Study Arms (4)

Unified Protocol, support by a specific therapist

EXPERIMENTAL

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.

Behavioral: Internet-based cognitive behavioral therapy (ICBT)

Unified Protocol, support by a team

EXPERIMENTAL

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.

Behavioral: Internet-based cognitive behavioral therapy (ICBT)

Individually tailored treatment, support by a specific therapist

EXPERIMENTAL

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.

Behavioral: Internet-based cognitive behavioral therapy (ICBT)

Individually tailored treatment, support by team

EXPERIMENTAL

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.

Behavioral: Internet-based cognitive behavioral therapy (ICBT)

Interventions

Internet-based cognitive behavioral therapy (ICBT) 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; Individually tailored treatment, support by team; Unified Protocol, support by a specific therapist; Unified Protocol, support by a team

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (2)

Linköping University

Linköping, Sweden

Location

Department of Behavioral Sciences and Learning

Linköping, Östergörland, 58183, Sweden

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Gerhard Andersson, PhD

  University Hospital, Linkoeping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: After recruitment finished, participants will be randomized to one of four groups that differ in type of treatment content (Unified Protocol or individually tailored) and type of support (by a specific therapist or by a team): (1) Unified Protocol with weekly support by a specific therapist, (2) Unified Protocol with weekly support by the team, (3) Individually tailored treatment with weekly support by a specific therapist, (4) Individually tailored treatment with weekly support by the team.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 17, 2024
• Study Start: January 8, 2024
• Primary Completion: April 8, 2024
• Study Completion: April 30, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

SE (2)