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

Anxiety Symptoms Clinical Trial

Official title:

Tailored or Transdiagnostic ICBT With a Specific Therapist or Team Support: A Factorial Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209541
• Other study ID #: INES
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: January 2024
• Source: Linkoeping University
• Contact: Gerhard Andersson, PhD
• Phone: +46-13285840
• Email: gerhard.andersson[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: April 30, 2026
• Est. primary completion date: April 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Symptoms
• Depression
• Depression Symptoms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	Department of Behavioral Sciences and Learning	Linköping	Östergörland
Sweden	Linköping University	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knowledge test (created by the research team)	Knowledge test about cognitive behavior therapy and how strategies in cognitive behavior therapy can be applied in every day situations. It consists of 16 questions and the respondent gets three answer options while one of the alternatives are correct.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Primary	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.
Primary	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	Perceived Stress Scale-14	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.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Insomnia Severity Index	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).	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Alcohol Use Disorder Identification Test	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.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Brunnsviken Brief Quality of Life Scale	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.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Patient Health Questionnaire-15	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.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Goldberg's (1999) IPIP representation of Costa McCrae's (1992) NEO-PI-R Domains	Measure of neuroticism. It consists of 10 items, scored from 0 (Very inaccurate) to 4 (Very accurate).	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	InCharge Financial Distress/Financial Well-Being Scale	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.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary	Rosenberg's Self-esteem Scale	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.	Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.