Clinical trial NCT06209541: Internet-based Cognitive Behavioral Therapy: a Factorial Randomized Controlled Trial About Treatment Content and Support
Official title: Tailored or Transdiagnostic ICBT with a Specific Therapist or Team Support: a Factorial Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression Symptoms
Anxiety Symptoms
Keywords: Internet-based cognitive behavioral therapy (ICBT)
Internet intervention
Depression
Anxiety
Individually tailored
Transdiagnostic
Alliance
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2024-01-17
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Becks Depression Inventory-II
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Beck Anxiety Inventory
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Secondary outcomes:
measure: Perceived Stress Scale-14
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Insomnia Severity Index
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Alcohol Use Disorder Identification Test
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Brunnsviken Brief Quality of Life Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Patient Health Questionnaire-15
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Goldberg's (1999) IPIP representation of Costa McCrae's (1992) NEO-PI-R Domains
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: InCharge Financial Distress/Financial Well-Being Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
measure: Rosenberg's Self-esteem Scale
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Other outcomes:
measure: Knowledge test (created by the research team)
timeFrame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Locations:
city: Linköping
country: Sweden
facility: Linköping University
city: Linköping
country: Sweden
facility: Department of Behavioral Sciences and Learning
state: Östergörland
Study officials:
affiliation: University Hospital, Linkoeping
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: