Atopic DermatitisNCT05517850
Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial
A study testing Therapist-guided cognitive behavioral therapy administered online and Self-guided digital intervention based on cognitive behavioral therapy in people with Atopic Dermatitis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The study aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (AD). Both interventions are based on Cognitive behavioral therapy. Participants will be recruited from advertisements in social media. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Therapist-guided cognitive behavioral therapy administered online and Self-guided digital intervention based on cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSweden
- Study dates
- 29 Nov 2022to 1 Oct 2024
- 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
- Self-reported AD diagnosed by physician (potential participants will disclose the circumstances of their diagnosis)
- No new types of medications introduced for six months prior, with no intention of future change
- Able to understand Swedish
- Access to the internet and a smartphone
Who cannot join
- Other disease or condition that has immediate treatment priority over AD. This could be an ongoing demanding treatment of a severe somatic or psychiatric condition. No specific diagnoses are inevitably a cause for exclusion, as potential participants will rather be evaluated on a case-to-case basis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Therapist-guided Cognitive Behavioral Therapy for Atopic Dermatitis Versus a Shortened Digital Self-care Intervention: A Randomized Non-Inferiority Trial
The study aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (AD). Both interventions are based on Cognitive behavioral therapy. Participants will be recruited from advertisements in social media. Measurements of AD symptoms and psychological well-being will be conducted at pre-treatment, post-treatment as well as 6-month and one-year follow-up.
Read the detailed description
Background: Digital self-care based on Cognitive-behavioral therapy (CBT) could be an effective alternative to guided CBT for people with atopic dermatitis (AD) and has the theoretical potential to significantly increase access to psychological treatment for patients with AD, whilst being cost-effective for health care organizations.
Aim: To investigate whether a shortened digital self-care intervention is noninferior to, and cost-effective compared with, a comprehensive and therapist-guided CBT treatment for AD.
Intervention: Participants randomized to guided care will receive internet-delivered cognitive behavior therapy for 12 weeks. Participants randomized to digital self-care will have access to a self-guided intervention for 12 weeks_
Design, setting, and participants: This is a single-blind, randomized clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. 174 adult participants with AD will be recruited through self-referral. Participants will be randomized 1:1 to the two experimental conditions. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analyzed intention-to-treat.
- Conditions
- Atopic Dermatitis
- Being tested
- Therapist-guided cognitive behavioral therapy administered online, Self-guided digital intervention based on cognitive behavioral therapy
- Keywords
- Cognitive behavioral therapy, Self-guided intervention, Digital intervention, Exposure therapy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-guided cognitive behavioral therapy administered onlineBehavioural
This intervention consists of 10 modules of education and interventions and lasts 12 weeks. An introduction provides information about CBT and AD. Step by step, the participants are introduced to the proposed active treatment components: mindfulness training, and exposure with response prevention. Through this whole process, the participant is guided by a therapist. The therapist may be contacted through a secure internet platform at any time and responds within 48 hours. Participants reads the education material, construct exercises to perform, describes their progress in homework assignments, and receives feedback from their therapist.
Self-guided digital intervention based on cognitive behavioral therapyBehavioural
Participants will access a digital platform, read information, and perform exercises in their everyday life. The main treatment components are mindfulness and exposure with response prevention, with a specific focus on itch. Participants will be able to practice mindfulness with the help of instructions and examples. Participants will receive detailed instructions and guidance, and get to choose exposure exercises from a long list of examples. Participants will also be free to create their own relevant exposure situations within the intervention. Digital self-care consists of 8 modules. The only active interventions, mindfulness and exposure are introduced week 1 and 2, respectively. From week 3-7, no new interventions are introduced and participants are advised to continue practicing the interventions, but there is a new theme of education each week, to act as inspiration for exercises. The last 4 weeks, the participant is merely advised to continue practice.
| Study group | Role | What they receive |
|---|---|---|
| Therapist-guided | Active comparator | 12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material Receives: Behavioral: Therapist-guided cognitive behavioral therapy administered online |
| Self-guided | Experimental | 12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material Receives: Behavioral: Self-guided digital intervention based on cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in atopic dermatitis symptoms
Patient oriented eczema scale (POEM). 7 items. Higher scores indicate greater severity of eczemic symptoms. Scores range from 0 to 28.
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Secondary outcomes (13)
Change in itching sensation
Peak pruritus rating scale (NRS). 2 items. Higher scores indicate more severe itch. Scores range from 1-10
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in stress reactivity
Perceived stress scale (PSS). 14 items. Higher scores indicate more stressed mood and greater reactivity. Score ranges from 0-56.
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in depressive symptoms
Patient Health Questionnaire.(PHQ-9). 9 items. Higher total scores indicate greater severity of depression. Scores range from 0 to 27.
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in skin-related quality of life
Dermatological Life Quality Index (DLQI). 10 items. Higher score indicate lower quality of life related to skin symptoms.Scores range from 0 to 30.
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in insomnia symptoms
Insomnia severity index (ISI). 7 items. Higher scores indicates more severe insomnia. Scores range from 0 to 28.
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Treatment credibility
Credibility/expectancy questionnaire (CEQ). The CEQ ranges from 0 to 10 points per item and 0 to 50 points in total, where a higher score reflects better treatment credibility.
Measured: 2 weeks after treatment start (baseline).
Intervention satisfaction
Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher scores indicating greater satisfaction. An average Client Satisfaction Questionnaire-8 score of at least 22 will provide support for the acceptability and feasibility of this intervention.
Measured: Post-treatment (12 weeks)
Quality of life for health economy analysis
Euro quality of life 5 dimensions (EQ5D). 5 items. Higher scored indicate higher quality of life. A calculation gives a total score from 0 to 100.
Measured: Post treatment (week 12) to one-year follow-up (week 60)
Health economics
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Measured: Change from pre-treatment (baseline) to post-treatment (week 12); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Post-treatment adherence to exposure exercises
Time spent on exercises (ToE) Adherence to the exposure exercises will be determined by an online questionnaire where it will be stated on a four point Likert scale will state to what extent participants have worked with exposure: "not at all", "occasionally", "more than half of the days" and "daily". Acceptable level of adherence will be set to at least 50 % of participants working actively with exposure a majority of the days during a week for 4 weeks or more.
Measured: Post-treatment (12 weeks)
Usability
The System Usability Scale (SUS). The SUS consists of ten items, with a range of 0-4 points per item. The items are summed up and calculated with a formula resulting in a total score between 0 and 100, with a higher score reflecting better system usability.
Measured: Post-treatment (12 weeks)
Adverse events
Adverse events (AE). Participants are asked if they have had an adverse event as a result of treatment, and if so to describe it. If they have experienced more than oneadverse event, the question is repeated.
Measured: Post-treatment (12 weeks)
Time spent on treating
Time spent on treatment (ToT): Time in minutes spent by therapists on writing messeges, phone calls, etc.
Measured: From week 1 to 12, throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start29 Nov 2022
- Primary completion5 Dec 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Martin Kraepelien, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517850
- Sponsor's protocol ID
- CBTADNI
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will be available upon reasonable request.
Publications
Kern D, Ljotsson B, Lonndahl L, Hedman-Lagerlof E, Molander O, Liliequist B, Bradley M, Lindefors N, Kraepelien M. Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2025 Feb 1;161(2):183-190. doi: 10.1001/jamadermatol.2024.5044.
PubMed 39693097Kern D, Ljotsson B, Lonndahl L, Hedman-Lagerlof E, Bradley M, Lindefors N, Kraepelien M. Brief self-guided digital intervention versus a comprehensive therapist-guided online cognitive behavioural therapy for atopic dermatitis: a trial protocol for a randomised non-inferiority trial. BMJ Open. 2023 Feb 28;13(2):e068908. doi: 10.1136/bmjopen-2022-068908.
PubMed 36854583
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Therapist-guided Cognitive Behavioral Therapy for Atopic Dermatitis Versus a Shortened Digital Self-care Intervention: A Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT05517850
- Acronym / sponsor ID
- CBTADNI
- Conditions
- Atopic Dermatitis
- Keywords
- Cognitive behavioral therapy, Self-guided intervention, Digital intervention, Exposure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 26 Aug 2022 (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 aims to test the hypothesized non-inferiority of a self-guided digital intervention compared to a therapist-guided variant for people with atopic dermatitis (AD). Both interventions are based on Cognitive behavioral therapy. Participants will be recruited from advertisements in social media. Measurements of AD symptoms and psychological well-being will be conducted at pre-treatment, post-treatment as well as 6-month and one-year follow-up.
Detailed description
Background: Digital self-care based on Cognitive-behavioral therapy (CBT) could be an effective alternative to guided CBT for people with atopic dermatitis (AD) and has the theoretical potential to significantly increase access to psychological treatment for patients with AD, whilst being cost-effective for health care organizations.
Aim: To investigate whether a shortened digital self-care intervention is noninferior to, and cost-effective compared with, a comprehensive and therapist-guided CBT treatment for AD.
Intervention: Participants randomized to guided care will receive internet-delivered cognitive behavior therapy for 12 weeks. Participants randomized to digital self-care will have access to a self-guided intervention for 12 weeks_
Design, setting, and participants: This is a single-blind, randomized clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. 174 adult participants with AD will be recruited through self-referral. Participants will be randomized 1:1 to the two experimental conditions. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analyzed intention-to-treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapist-guided | Active comparator | Behavioral: Therapist-guided cognitive behavioral therapy administered online12 weeks of therapist-guided, exposure-based intervention via tha internet, with comprehensive material |
| Self-guided | Experimental | Behavioral: Self-guided digital intervention based on cognitive behavioral therapy12 weeks of self-guided, exposure-based intervention via the internet, with shortened and improved material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-reported AD diagnosed by physician (potential participants will disclose the circumstances of their diagnosis)
- No new types of medications introduced for six months prior, with no intention of future change
- Able to understand Swedish
- Access to the internet and a smartphone
Key exclusion criteria (1 listed)
- Other disease or condition that has immediate treatment priority over AD. This could be an ongoing demanding treatment of a severe somatic or psychiatric condition. No specific diagnoses are inevitably a cause for exclusion, as potential participants will rather be evaluated on a case-to-case basis.
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 |
|---|---|---|
| Therapist-guided cognitive behavioral therapy administered onlineThis intervention consists of 10 modules of education and interventions and lasts 12 weeks. An introduction provides information about CBT and AD. Step by step, the participants are introduced to the proposed active treatment components: mindfulness training, and exposure with response prevention. Through this whole process, the participant is guided by a therapist. The therapist may be contacted through a secure internet platform at any time and responds within 48 hours. Participants reads the education material, construct exercises to perform, describes their progress in homework assignments, and receives feedback from their therapist. | Behavioural | Therapist-guided |
| Self-guided digital intervention based on cognitive behavioral therapyParticipants will access a digital platform, read information, and perform exercises in their everyday life. The main treatment components are mindfulness and exposure with response prevention, with a specific focus on itch. Participants will be able to practice mindfulness with the help of instructions and examples. Participants will receive detailed instructions and guidance, and get to choose exposure exercises from a long list of examples. Participants will also be free to create their own relevant exposure situations within the intervention. Digital self-care consists of 8 modules. The only active interventions, mindfulness and exposure are introduced week 1 and 2, respectively. From week 3-7, no new interventions are introduced and participants are advised to continue practicing the interventions, but there is a new theme of education each week, to act as inspiration for exercises. The last 4 weeks, the participant is merely advised to continue practice. | Behavioural | Self-guided |
Primary outcome
Change in atopic dermatitis symptoms
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Patient oriented eczema scale (POEM). 7 items. Higher scores indicate greater severity of eczemic symptoms. Scores range from 0 to 28.
13 secondary outcomes
Change in itching sensation
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in stress reactivity
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in depressive symptoms
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in skin-related quality of life
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Change in insomnia symptoms
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Treatment credibility
Time frame: 2 weeks after treatment start (baseline).
Intervention satisfaction
Time frame: Post-treatment (12 weeks)
Quality of life for health economy analysis
Time frame: Post treatment (week 12) to one-year follow-up (week 60)
Health economics
Time frame: Change from pre-treatment (baseline) to post-treatment (week 12); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)
Post-treatment adherence to exposure exercises
Time frame: Post-treatment (12 weeks)
Usability
Time frame: Post-treatment (12 weeks)
Adverse events
Time frame: Post-treatment (12 weeks)
Time spent on treating
Time frame: From week 1 to 12, throughout
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 12 Mar 2025.
- Derived from this study: PubMed 39693097Kern D, Ljotsson B, Lonndahl L, Hedman-Lagerlof E, Molander O, Liliequist B, Bradley M, Lindefors N, Kraepelien M. Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2025 Feb 1;161(2):183-190. doi: 10.1001/jamadermatol.2024.5044.
- Derived from this study: PubMed 36854583Kern D, Ljotsson B, Lonndahl L, Hedman-Lagerlof E, Bradley M, Lindefors N, Kraepelien M. Brief self-guided digital intervention versus a comprehensive therapist-guided online cognitive behavioural therapy for atopic dermatitis: a trial protocol for a randomised non-inferiority trial. BMJ Open. 2023 Feb 28;13(2):e068908. doi: 10.1136/bmjopen-2022-068908.
- Individual participant dataSharing planned: No. Individual data will be available upon reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-guided cognitive behavioral therapy administered online and Self-guided digital intervention based on cognitive behavioral therapy in people with Atopic Dermatitis, run by Karolinska Institutet 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 1 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 12 Mar 2025. 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 in atopic dermatitis symptoms (time frame: Change from pre-treatment (baseline) to post-treatment (week 12); weekly (week1-11); change from pre-treatment (baseline) to 6 month follow-up (week 36); change from pre-treatment (baseline) to 1 year follow-up (week 60)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05517850, which also lists 2 linked publications.
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 12 Mar 2025.