NCT Number: NCT06209541
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Department of Behavioral Sciences and Learning, Linköping, Östergörland, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Linkoeping University
Other Gov
Tailored or Transdiagnostic ICBT with a Specific Therapist or Team Support: a Factorial Randomized Controlled Trial
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