Depressive Disorder, MajorNCT04260750
ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content
A study testing Internet-administered Cognitive behavioral therapy (ICBT) in people with Depressive Disorder, Major and Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
Trial summary
The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major, Depressive Symptoms
- What is being tested?
- Internet-administered 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
- 246 participants
- Where
- 1 siteSweden
- Study dates
- 13 Jan 2020to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
- 18 years or older.
- Adequate ability to understand and speak Swedish.
- Access to the internet and a smartphone/computer.
Who cannot join
- Other ongoing psychological treatment or counselling.
- Recent (within the past 3 months) changes in the dose of psychotropic medication.
- Prior diagnosis of psychosis, bipolar disorder, or substance dependence.
Trial locations and contacts
1 site in 1 country.
About this study
The study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.
Read the detailed description
The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.
- Conditions
- Depressive Disorder, Major, Depressive Symptoms
- Being tested
- Internet-administered Cognitive behavioral therapy (ICBT)
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-administered Cognitive behavioral therapy (ICBT)Behavioural
The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation).
The fifteen modules are:
Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention.
The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview.
| Study group | Role | What they receive |
|---|---|---|
| Expert-chosen content, regular guidance | Experimental | Content chosen by the therapist, weekly guidance by a therapist. Receives: Behavioral: Internet-administered Cognitive behavioral therapy (ICBT) |
| Expert-chosen content, on-demand guidance | Experimental | Content chosen by the therapist, guidance upon request from the health care team. Receives: Behavioral: Internet-administered Cognitive behavioral therapy (ICBT) |
| Participant-chosen content, regular guidance | Experimental | Content chosen by participants themselves, weekly guidance by a therapist. Receives: Behavioral: Internet-administered Cognitive behavioral therapy (ICBT) |
| Participant-chosen content, on-demand guidance | Experimental | Content chosen by participants themselves, guidance upon request from the health care team. Receives: Behavioral: Internet-administered Cognitive behavioral therapy (ICBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Becks Depression Inventory-II (BDI-II)
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). 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.
Measured: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Change on Patient Health Questionnaire (PHQ-9)
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
Measured: Baseline, during week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of the intervention, post-intervention (after 11 weeks), 12 months after the end of intervention.
Secondary outcomes (3)
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
Measure of symptoms of generalised anxiety disorder (GAD). Seven items, the score is interpreted by summing up the score from each individual item. Higher scores indicate more severe problems with worry and generalised anxiety. The total sum ranges from 0 to 21 with cut-offs of 5, 10, and 15 representing mild, moderate and severe generalised anxiety.
Measured: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Measure of quality of life, 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: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Change on Insomnia Severity Index (ISI)
Measure of insomnia severity and symptoms of disordered sleep. The total score can range between 0 (no sleep problems) to 28 (severe sleep problems and insomnia). 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: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start13 Jan 2020
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- Factor one: Regular therapist support by a therapist/On-demand guidance by a health care team (the participants themselves can choose to contact a physician, a nurse, a clinical psychologist, an IT-technician and/or the principal investigator of the study). Factor two: The content (the modules) is chosen by the participants themselves/The content is chosen by the therapist conducting the intake interview.
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
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, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260750
- Sponsor's protocol ID
- LUNA
- Status last verified
- Apr 2021
- First submitted
- 30 Jan 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICBT for Depression - A Factorial Investigation of Kinds of Therapist Support and Self-/Expert-selected Content
- ClinicalTrials.gov ID
- NCT04260750
- Acronym / sponsor ID
- LUNA
- Conditions
- Depressive Disorder, Major, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 7 Feb 2020 (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 study is a factorial randomized controlled trial investigating the efficacy of difference versions of internet-administered cognitive behavioral therapy.
Detailed description
The study is a 2 x 2 design. The first factor thought to be of relevance for the efficacy is the whether the content is selected by the participants themselves or by a therapist. The second factor consists of two levels: regular, continuous weekly support from a therapist or guidance on demand by a health care team consisting of a physician, a nurse, a clinical psychologist, an IT-technician and the principal investigator of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Factor one: Regular therapist support by a therapist/On-demand guidance by a health care team (the participants themselves can choose to contact a physician, a nurse, a clinical psychologist, an IT-technician and/or the principal investigator of the study). Factor two: The content (the modules) is chosen by the participants themselves/The content is chosen by the therapist conducting the intake interview.
| Arm | Type | Receives |
|---|---|---|
| Expert-chosen content, regular guidance | Experimental | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)Content chosen by the therapist, weekly guidance by a therapist. |
| Expert-chosen content, on-demand guidance | Experimental | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)Content chosen by the therapist, guidance upon request from the health care team. |
| Participant-chosen content, regular guidance | Experimental | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)Content chosen by participants themselves, weekly guidance by a therapist. |
| Participant-chosen content, on-demand guidance | Experimental | Behavioral: Internet-administered Cognitive behavioral therapy (ICBT)Content chosen by participants themselves, guidance upon request from the health care team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current depressive symptoms equivalent to a score of at least 5 on Patient Health Questionnaire 9 and a minimum of 10 points on Becks Depression Inventory.
- 18 years or older.
- Adequate ability to understand and speak Swedish.
- Access to the internet and a smartphone/computer.
Key exclusion criteria (3 listed)
- Other ongoing psychological treatment or counselling.
- Recent (within the past 3 months) changes in the dose of psychotropic medication.
- Prior diagnosis of psychosis, bipolar disorder, or substance dependence.
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-administered Cognitive behavioral therapy (ICBT)The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation). The fifteen modules are: Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention. The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview. | Behavioural | Expert-chosen content, on-demand guidance, Expert-chosen content, regular guidance, Participant-chosen content, on-demand guidance, Participant-chosen content, regular guidance |
Primary outcome
Change on Becks Depression Inventory-II (BDI-II)
Time frame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Measure of depressive symptoms. Possible range for the total sum: 0 to 63 (created by summing up the score from each item). 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.
Change on Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, during week 1, 2, 3, 4, 5, 6, 7, 8, 9, and 10 of the intervention, post-intervention (after 11 weeks), 12 months after the end of intervention.
Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
3 secondary outcomes
Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Change on Brunnsviken Brief Quality of Life Scale (BBQ)
Time frame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Change on Insomnia Severity Index (ISI)
Time frame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
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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
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-administered Cognitive behavioral therapy (ICBT) in people with Depressive Disorder, Major and Depressive Symptoms, run by Linkoeping University at 1 site 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 3 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: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change on Becks Depression Inventory-II (BDI-II) (time frame: Baseline, after the intervention (after 11 weeks), 12 months after the end of intervention.). 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 20 Apr 2021.