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Comparison of the effectiveness of emotion regulation training and problem-solving skills training on biological indicators, psychological distress, and self-care in diabetic nephropathy patients

Comparison of the effectiveness of emotion regulation training and problem-solving skills training on biological indicators, psychological distress, and self-care in diabetic nephropathy patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251121068066N2
Enrollment
60
Registered
2025-12-05
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Diabetic nephropathy. Diabetes mellitus due to underlying condition with diabetic nephropathy

Interventions

Intervention 1: Intervention group: Emotion Regulation Training: Participants receive an 8-session program (weekly, 90 minutes) based on Gross’s (2001) emotion regulation model. The sessions include e

Sponsors

Islamic Azad University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 55 Years

Inclusion criteria

Inclusion criteria: Diagnosis of type 2 diabetic nephropathy confirmed by an endocrinologist or internal medicine specialist based on laboratory criteria (HbA1c > 6.5% and FBS > 126 mg/dL). Age 40–55 years. Disease duration between 5 and 10 years. No major psychiatric disorders and no severe comorbid physical illnesses (e.g., cardiovascular or ophthalmic complications). Minimum literacy level equivalent to sixth grade. No psychological or psychiatric intervention during the past year. Ability to communicate verbally and perform required activities. Stable medication regimen during the past three months.

Exclusion criteria

Exclusion criteria: Diagnosis of type 1 diabetic nephropathy. Hospitalization during the study period. Withdrawal or unwillingness to continue participation. Development of severe diabetic nephropathy complications during the intervention. Missing more than one intervention session.

Design outcomes

Primary

MeasureTime frame
Biological indices: Glycosylated hemoglobin (HbA1c) and fasting blood sugar (FBS) to assess metabolic control.Psychological distress: Anxiety, depression, and helplessness measured using the 10-item Kessler Questionnaire (K10).Self-care: Diet, physical activity, blood sugar monitoring, medication adherence, foot care, and smoking, measured using the Toobert Diabetes Self-Care Questionnaire. Timepoint: Baseline (pre-test), immediately post-intervention (after 8 sessions), and 3-month follow-up. Method of measurement: Biomarkers: Measured via standard laboratory tests (blood samples) at the Tehran Sound and Television Health and Treatment Center.Psychological distress: Assessed using the 5-item Kessler Questionnaire (score range 0–40; higher scores indicate greater distress).Self-care: Assessed using the Toobert Diabetes Self-Care Questionnaire (based on days of behavior adherence in the past week; higher scores indicate better self-care). Both questionnaires were self-reported under researcher supervision.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoozan Emamipour

Islamic Azad University

emamipursd@yahoo.com+98 912 207 1657

Outcome results

None listed

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