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NCT05517850
Therapist-guided vs Self-guided CBT for AD: Non-inferiority Trial
NA trial testing Therapist-guided cognitive behavioral therapy administered online in Atopic Dermatitis in 168 participants. Completed in 1 October 2024.
5 December 2023
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 168 |
| Start date | 29 November 2022 |
| Primary completion | 5 December 2023 |
| Estimated completion | 1 October 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Therapist-guided cognitive behavioral therapy administered online
- Self-guided digital intervention based on cognitive behavioral therapy
Conditions studied
- Atopic Dermatitis — all drugs for Atopic Dermatitis →
Sponsor
Karolinska Institutet
Who can join
18 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Digital therapeutics in the clinic.
Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536 -
Self-Guided vs Clinician-Guided Online Cognitive Behavioral Therapy for Atopic Dermatitis: A Randomized Clinical Trial.
Kern D, Ljótsson B, Lönndahl L, Hedman-Lagerlöf E, et al · · 2025 · cited 4× · PMID 39693097 · DOI 10.1001/jamadermatol.2024.5044 -
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.
Kern D, Ljótsson B, Lönndahl L, Hedman-Lagerlöf E, et al · · 2023 · cited 3× · PMID 36854583 · DOI 10.1136/bmjopen-2022-068908
Verify or expand the search:
- PubMed search for NCT05517850
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atopic Dermatitis
Currently open trials in the same condition.
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- NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
- NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05517850 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Karolinska Institutet
- Last refreshed: 12 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05517850.
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