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A trial comparing psychological therapy with steroids in treatment of chronic urticaria patients

Cognitive Behavioral Therapy versus Steroids for optimizing the conventional therapy of chronic spontaneous urticaria: a single blinded, factorial randomized controlled trial - CoBeTS trial - CoBeTS Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020194
Enrollment
308
Registered
2019-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L501- Idiopathic urticaria

Interventions

Intervention1: Cognitive behavioral therapy, intramuscular injection of triamcinolone acetonide: Cognitive behavioral therapy 30 minutes session once a month + intramuscular injection of triamcinolone

Sponsors

Department of Science and Technology Science and Engineering Research Board DSTSERB
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for cases (serum (154 cases) and skin (20 samples): 1. Consecutive consenting patients of both gender aged 18-60 years, attending the â??Chronic Urticaria clinicâ?? of the dermatology OPD of JIPMER diagnosed with chronic spontaneous urticaria, characterized by the presence of continuous or recurrent weals with or without angioedema of greater than 6 weeks duration. Inclusion criteria for controls (serum)(154 controls): 1. Age and gender matched healthy subjects Inclusion criteria for controls (skin): (20 samples) 1.Discarded skin samples obtained for split thickness graft for treatment of ulcers

Exclusion criteria

Exclusion criteria: Exclusion criteria for both cases (154 cases) and controls (154 controls): 1.Subjects not on any medication for the past three months prior to recruitment other than antihistamines 2.Physical urticaria and urticarial vasculitis 3.Pregnant and lactating women 4.Pre-existing endocrine disorders 5.Pre-existing psychiatric illness 6.Pre-existing chronic illness like diabetes, hypertension, hepatic and renal disease, connective tissue diseases, malignancies 7.Other inflammatory skin diseases like psoriasis, lichen planus, vitiligo, pityriasis rubra pilaris, erythroderma

Design outcomes

Primary

MeasureTime frame
Effectiveness of intervention among CSU patients (154) on clinical outcome: 1.stress scores (Daily Hassles and Uplifts Scale-Revised (DHUS-R);Presumptive Stressful Life Events Scale (PSLE);Perceived stress scale (PSS)-10 item); 2.disease activity and disease severity scores (Urticaria activity score (sum score of 7 consecutive days) (UAS 7);Urticaria severity score (USS);Urticaria control test (UCT; 3.quality of life scores(Chronic urticaria- Quality of life (CU-Q2oL); 4. medication usageTimepoint: At recruitment; Follow up at 1,2,3 months

Secondary

MeasureTime frame
Autoreactivity among cases with CSU(154) 1.Autologous serum skin test (ASST) 2.Basophil histamine release assay (BHRA) 3.Specific IgG autoantibodies against FcÉ?R1αTimepoint: At recruitment;Comparison of cutaneous neuropeptide expression between cases (20) and controls (20): 1. immunohistchemistry of NGF, SP , CGRP, Neuropeptide YTimepoint: At recruitment;Comparison of stress scores between cases (154) and controls (154) 1.Daily Hassles and Uplifts Scale-Revised (DHUS-R 2.Presumptive Stressful Life Events Scale (PSLE) 3.Perceived stress scale (PSS)-10 item)Timepoint: At recruitment;Comparison of the following serum levels between cases (154) and controls (154): 1.stress hormones and central HPA axis activity:CRH, ACTH, cortisol, DHEAS, Prolactin, DHEAS/Cortisol ratio 2.inflammatory cytokines:IL-6, IL-18, hs CRP, VEGF 3.neuropeptides: NGF, SP , CGRP, Neuropeptide YTimepoint: At recruitment;Comparison of expression of cutaneous HPA axis activity between cases (20)and controls (20): 1.m RNA expression of CRH, CRH-R1, ACTH, hydroxysteroid 11 beta dehydrogenase 1 and 2 (HSD11B1, HSD11B2); glucocorticoid receptors - nuclear receptor subfamily 3, group C, member 1a (NR3C1a) and b (NR3C1b) 2.immunohistochemistry of CRH, CRH-R1Timepoint: At recruitment;Effectiveness of intervention among CSU patients (154) on serum levels of: 1.stress hormones and central HPA axis activity:CRH, ACTH, cortisol, DHEAS, Prolactin, DHEAS/Cortisol ratio 2.inflammatory cytokines:IL-6, IL-18, hs CRP, VEGF 3.neuropeptides: NGF, SP , CGRP, Neuropeptide YTimepoint: At recruitment; Follow up at 3 months

Countries

India

Contacts

Public ContactDr M Malathi

Jawaharlal Institute of Postgraduate Medical Education and Research

mmalathi.dr@live.com07373842888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026