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The Effects of COgNitive behaviour therapy and liFEstyle tenDENCE therapy (CONFEDENCE) on the biomarkers of Nigerian Lupus Patients with comorbid depression: A mechanistic randomised controlled feasibility trial

The Effects of COgNitive behaviour therapy and liFEstyle tenDENCE therapy (CONFEDENCE) on the biomarkers of Nigerian Lupus Patients with comorbid depression: A mechanistic randomised controlled feasibility trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202606538950677
Enrollment
16
Registered
2026-06-02
Start date
2026-06-04
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Mental and Behavioural Disorders Skin and Connective Tissue Diseases

Interventions

COgNitive behaviour therapy and liFEstyle tenDENCE therapy also known as CONFEDENCE
Treatment As Usual also known as TAU

Sponsors

Centre in Africa for Living and Learning
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Adults (=18) - Meet ACR/EULAR criteria for lupus - =5 Patient Health Questionnaire (PHQ-9) - Stable background lupus therapy (=4 weeks) - Able to participate in English - Available for follow-up

Exclusion criteria

Exclusion criteria: - Acute psychosis/mania - Imminent suicidality - Substance dependence requiring intensive care - Severe cognitive impairment, or concurrent structured psychotherapy initiation

Design outcomes

Primary

MeasureTime frame
Test whether the CONFEDENCE is feasible and acceptable—

Secondary

MeasureTime frame
Test whether the CONFEDENCE reduces lupus activities and damage indices in biomarkers of patients ;Test estimate effect sizes for depressive (PHQ-9), anxiety (GAD-7), perceived stress (PSS-10), lupus damage (BILD), health quality (EuroQol), and lupus disease activity (SLEDAI-2K).—

Countries

Nigeria

Contacts

Public ContactJuliet Clerk

Centre in Africa for Living and Learning

info@call-africa.org+2348137659982

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026