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NCT05617066
Stress, Scleroderma and Quality of Life
NA trial testing Cognitive behavioral therapy in Scleroderma in 150 participants. Completed in 1 September 2023.
31 March 2023
Quick facts
| Lead sponsor | Asociación Española de Esclerodermia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | other |
| Enrollment | 150 |
| Start date | 26 November 2022 |
| Primary completion | 31 March 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Cognitive behavioral therapy
Conditions studied
- Scleroderma — all drugs for Scleroderma →
Sponsor
Asociación Española de Esclerodermia
Who can join
18 and older, any sex, with Scleroderma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
150 patients of legal age will participate in this project, diagnosed with systemic sclerosis. Patients will be randomly assigned, as will be detailed later, to one of the following three groups: Therapy Group (GT): This group will be made up of 50 patients who will receive cognitive behavioral therapy of coping with stress (online modality) in groups of 10-12 people during twelve sessions Consecutive weekly courses of 1.5 to 2 hours duration taught by psychology professionals. of this mode 4 subgroups will be made. Psychological Support Group (AP): This group will be made up of 50 patients who will receive psychoeducation about stress and its consequences and the specific stress suffered by people with a autoimmune disease such as scleroderma. It will have a duration of twelve weekly sessions. Consecutive sessions of 1.5 to 2 hours in length taught by professional psychologists. In this way they will 4 subgroups. Usual Care Group (CG): This group will be made up of 50 patients who will follow their usual care. Later, once the study is over, they will be offered to participate in coping with stress to the person who is interested.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05617066
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Scleroderma
Currently open trials in the same condition.
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- NCT06801119 — Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs） · Phase 1 · recruiting
- NCT06554132 — Respiratory Muscle Strength and Aerobic Capacity in Scleroderma · recruiting
- NCT03800017 — Skeletal Muscle Function in Interstitial Lung Disease · NA · recruiting
- NCT06598982 — Investigation of Respiratory Muscle Sarcopenia in Patients With Systemic Sclerosis · recruiting
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 NCT05617066 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Asociación Española de Esclerodermia
- Last refreshed: 1 February 2024
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/NCT05617066.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing