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NCT04797273
Internet-based CBT vs. TAU for Stress-related Disorders
NA trial testing Internet-based cognitive behavior therapy in Adjustment Disorders in 300 participants. Completed in 1 June 2024.
1 June 2024
Quick facts
| Lead sponsor | Karolinska Institutet |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 25 March 2021 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Internet-based cognitive behavior therapy
- Internet-based structured treatment-as-usual
Conditions studied
- Adjustment Disorders — all drugs for Adjustment Disorders →
- Exhaustion Disorder — all drugs for Exhaustion Disorder →
Sponsor
Karolinska Institutet
Who can join
Adults 18 to 65, any sex, with Adjustment Disorders or Exhaustion Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Stress-related mental illness is common and one of the main causes of sick leave in Sweden. Cognitive behavior therapy (CBT) is a promising treatment, but access to treatment is low. In a previously conducted study, we found that internet-based CBT in comparison to a waitlist control group was effective in reducing symptoms of stress. The aim of the present study is to take the next step and compare Internet-based CBT for stress-related disorders to an active control condition.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Objective cognitive functioning in patients with stress-related disorders: a cross-sectional study using remote digital cognitive testing.
Franke Föyen L, Sennerstam V, Kontio E, Lekander M, et al · · 2023 · cited 6× · PMID 37550693 · DOI 10.1186/s12888-023-05048-5 -
Psychometric and structural properties of the Karolinska Exhaustion Disorder Scale: a 1,072-patient study.
Lindsäter E, van de Leur JC, Rück C, Hedman-Lagerlöf E, et al · · 2023 · cited 5× · PMID 37660017 · DOI 10.1186/s12888-023-05138-4 -
Internet-Delivered Treatment for Stress-Related Disorders: A Randomized Controlled Superiority Trial of Cognitive Behavioral Therapy versus General Health Promotion.
Sennerstam V, Franke Föyen L, Kontio E, Svärdman F, et al · · 2025 · cited 3× · PMID 40334656 · DOI 10.1159/000546221 -
Long-Term Effects of Cognitive Behavioral Therapy on Sickness Absence and Cognitive Functioning in Patients with Stress-Related Disorders: Secondary Results from a Randomized Clinical Trial.
Franke Föyen L, Sennerstam V, Kontio E, Lekander M, et al · · 2025 · PMID 40628239 · DOI 10.1159/000547266 -
Predicting Therapy Outcomes in Patients With Stress-Related Disorders: Protocol for a Predictive Modeling Study.
Franke Föyen L, Sennerstam V, Kontio E, Flygare O, et al · · 2025 · PMID 40132191 · DOI 10.2196/65790
Verify or expand the search:
- PubMed search for NCT04797273
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04797273 (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: 15 September 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/NCT04797273.
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