Spiritual Care for Psychological and Glycemic Outcomes in Type 2 Diabetes

NCT07333625 | Completed

• 2 other identifiers: SC-DMT2-2024-AMM1853/KEPK/STIKES-NHM/EC/V/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of integrating spiritual care into the management of patients with type 2 diabetes mellitus. The study examines whether a structured spiritual care program can improve psychological resilience, reduce psychological distress, and help control blood glucose levels in adults with type 2 diabetes. Participants receive standard diabetes care, with one group also receiving spiritual care interventions delivered by trained health professionals. The findings of this study are expected to support a more holistic approach to diabetes management that addresses both physical and psychological well-being.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (3)

• Psychological Resilience

  Psychological resilience measured using a validated resilience questionnaire, with higher scores indicating greater resilience.

  Baseline and post-intervention (4 weeks)

• Psychological Distress

  Psychological distress assessed using a standardized psychological distress scale, with higher scores indicating greater distress.

  Baseline and post-intervention (4 weeks)

• Blood Glucose Level

  Fasting blood glucose level measured in milligrams per deciliter (mg/dL).

  Baseline and post-intervention (4 Weeks)

Study Arms (2)

Spiritual Care Plus Standard Care

EXPERIMENTAL

Participants received standard diabetes care combined with a structured spiritual care program.

Behavioral: Spiritual Care Program; Behavioral: Standard Diabetes Care

Standard Diabetes Care

ACTIVE COMPARATOR

Participants received standard diabetes care without additional spiritual care intervention.

Behavioral: Standard Diabetes Care

Interventions

Spiritual Care Program BEHAVIORAL

A structured spiritual care program integrated into standard diabetes management, including guided spiritual reflection, supportive counseling, and meaning-centered support delivered by trained healthcare providers.

Spiritual Care Plus Standard Care

Standard Diabetes Care BEHAVIORAL

Standard diabetes management provided according to hospital clinical guidelines, including medical treatment, dietary counseling, and routine diabetes education.

Spiritual Care Plus Standard Care; Standard Diabetes Care

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who can read and communicate well;
• Clinically diagnosed with type II di-abetes; and
• Patients over the age of 40
• Willing to participate and provide written informed consent

You may not qualify if:

• Diagnosed with severe psychiatric disorders
• Having cognitive impairment that interferes with participation

Sponsors & Collaborators

• Universitas Noor Huda Mustofa: lead

Study Sites (1)

RSU Anna Medika Madura

Bangkalan, East Java, 69116, Indonesia

Location

Related Publications (1)

• Koenig HG. Religion, spirituality, and health: the research and clinical implications. ISRN Psychiatry. 2012 Dec 16;2012:278730. doi: 10.5402/2012/278730. Print 2012.

  PMID: 23762764 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Faisal Amir

  Universitas Noor Huda Mustofa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Universitas Noor Huda Mustofa

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: January 12, 2026
• Study Start: June 2, 2024
• Primary Completion: June 5, 2024
• Study Completion: July 5, 2024
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)