Depression SymptomsNCT06209541
Internet-based Cognitive Behavioral Therapy: a Factorial Randomized Controlled Trial About Treatment Content and Support
A study testing Internet-based cognitive behavioral therapy (ICBT) in people with Depression Symptoms and Anxiety Symptoms, run by Linkoeping University at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Symptoms, Anxiety Symptoms
- What is being tested?
- Internet-based cognitive behavioral therapy (ICBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesSweden
- Study dates
- 8 Jan 2024to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Linköping University
Linköping
Department of Behavioral Sciences and Learning
Linköping, Östergörland, 58183
About this study
Official title: Tailored or Transdiagnostic ICBT with a Specific Therapist or Team Support: a Factorial Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Depression Symptoms, Anxiety Symptoms
- Being tested
- Internet-based cognitive behavioral therapy (ICBT)
- Keywords
- Internet-based cognitive behavioral therapy (ICBT), Internet intervention, Depression, Anxiety, Individually tailored, Transdiagnostic, Alliance
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapy (ICBT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Internet-based cognitive behavioral therapy (ICBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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).
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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).
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
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.
Measured: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start8 Jan 2024
- Primary completion8 Apr 2024
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209541
- Sponsor's protocol ID
- INES
- Status last verified
- Oct 2024
- First submitted
- 8 Jan 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored or Transdiagnostic ICBT with a Specific Therapist or Team Support: a Factorial Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06209541
- Acronym / sponsor ID
- INES
- Conditions
- Depression Symptoms, Anxiety Symptoms
- Keywords
- Internet-based cognitive behavioral therapy (ICBT), Internet intervention, Depression, Anxiety, Individually tailored, Transdiagnostic, Alliance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol, support by a specific therapist | Experimental | Behavioral: 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. |
| Unified Protocol, support by a team | Experimental | Behavioral: 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 | Experimental | Behavioral: 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. |
| Individually tailored treatment, support by team | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 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 |
Primary outcome
Becks Depression Inventory-II
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.
Beck Anxiety Inventory
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).
8 secondary outcomes
Perceived Stress Scale-14
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Insomnia Severity Index
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Alcohol Use Disorder Identification Test
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Brunnsviken Brief Quality of Life Scale
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Patient Health Questionnaire-15
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Goldberg's (1999) IPIP representation of Costa McCrae's (1992) NEO-PI-R Domains
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
InCharge Financial Distress/Financial Well-Being Scale
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Rosenberg's Self-esteem Scale
Time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Related trials for Depression Symptoms
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Not yet recruitingObservational study
Assessment of the Seasonality of Depressive Symptoms in Adolescents
Depressive Symptoms
Recruiting
The Mindful Smartphone Use Study
Depression and/or Anxiety Symptoms, Problematic Phone Use Behavior
Recruiting
Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.
Depressive Symptoms, Allostatic Load
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, PhD principal investigator
University Hospital, Linkoeping
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavioral therapy (ICBT) in people with Depression Symptoms and Anxiety Symptoms, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Becks Depression Inventory-II (time frame: Change between baseline, end of treatment after eight weeks and follow-up at 12 months after treatment termination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 28 Oct 2026.