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

Not Applicable

Active, not recruiting

• Conditions: Depression Symptoms; Anxiety Symptoms
• Interventions: Behavioral: Internet-based cognitive behavioral therapy (ICBT)

• Registration Number: NCT06209541
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2024-01-08
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Study First Posted: 2024-01-17
• Primary Completion: 2024-04-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Beck Anxiety Inventory	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	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).
Becks Depression Inventory-II	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	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.

Secondary Outcome Measures

Name	Time	Method
Rosenberg's Self-esteem Scale	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	Measure of self-esteem, consisting of ten items where five of them are positively and five of them are negatively worded. Sum scores range between 0-30. A higher score indicates higher self-esteem.
Perceived Stress Scale-14	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	A questionnaire that aims to measure symptoms of stress. I contains 14 items that are scored on a range between 0 (never) to 4 (very often). The total score range is between 0-56 and a higher score reflects higher levels of perceived stress.
Brunnsviken Brief Quality of Life Scale	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	Measure of quality of life with a total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
Patient Health Questionnaire-15	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	Measure of somatic symptoms. It consists of 15 items for women and 14 items for men (because the item about "menstrual cramps or other problems with your periods" are removed). The symptoms are rated on a scale from 0 (not bothered) to 2 (bothered a lot). Total score ranges from 0 to 30 for women and 0 to 28 for men.
Insomnia Severity Index	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	Measure of insomnia severity and symptoms of disordered sleep. Norm score ranges include low likelihood of sleep problems (0 to 7 points), some sleep problems (8 to 14 points), moderate sleep problems (15 to 21 points), severe sleep problems (22 to 28 points).
Alcohol Use Disorder Identification Test	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	A 10-item screening tool to assess alcohol consumption, drinking behaviors, and alcohol-related problems. 10 items and scores ranging from 0-40 with higher scores indicating a higher level of alcohol use.
Goldberg's (1999) IPIP representation of Costa McCrae's (1992) NEO-PI-R Domains	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	Measure of neuroticism. It consists of 10 items, scored from 0 (Very inaccurate) to 4 (Very accurate).
InCharge Financial Distress/Financial Well-Being Scale	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.	A measure aiming to measure distress related to the individual's economic situation. It contains of eight questions where the respondent gets to answer on a scale from 1 to 10. A higher score indicates lower economic distress.

Trial Locations

Locations (2)

Linköping University; 🇸🇪 Linköping, Sweden

Department of Behavioral Sciences and Learning; 🇸🇪 Linköping, Östergörland, Sweden