Spiritual Care for Psychological and Glycemic Outcomes in Type 2 Diabetes (SC-DMT2)

December 31, 2025 updated by: Faisal Amir, Universitas Noor Huda Mustofa

Integrating Spiritual Care Into Type 2 Diabetes Management: Effects on Psychological Resilience, Distress, and Glycemic Control

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled clinical trial designed to evaluate the impact of integrating spiritual care into standard management for adults with type 2 diabetes mellitus. Psychological distress and reduced resilience are common among patients with chronic illnesses such as diabetes and may negatively influence glycemic control. Integrating spiritual care into routine diabetes management may help address these psychosocial challenges and improve overall patient well-being.

Eligible participants with type 2 diabetes mellitus were randomly assigned to one of two groups. The experimental group received standard diabetes care combined with a structured spiritual care program, while the control group received standard diabetes care alone. The spiritual care intervention was delivered by trained health professionals and included supportive spiritual counseling, reflective practices, and discussions tailored to patients' beliefs and coping needs.

Primary outcomes of the study included changes in psychological resilience, psychological distress, and glycemic control as measured by blood glucose levels. Secondary outcomes included additional psychological and clinical indicators relevant to diabetes management. Outcome assessments were conducted at baseline and after completion of the intervention period.

The study was conducted in a hospital setting in Indonesia and followed ethical principles for research involving human participants, with approval obtained from an institutional ethics committee. The findings are expected to provide evidence to support holistic and patient-centered approaches to diabetes care that integrate spiritual and psychological dimensions alongside standard medical treatment.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Bangkalan, East Java, Indonesia, 69116
        • RSU Anna Medika Madura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spiritual Care Plus Standard Care
Participants received standard diabetes care combined with a structured spiritual care program.
Behavioral: Spiritual Care Program
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.
Behavioral: Standard Diabetes Care
Standard diabetes management provided according to hospital clinical guidelines, including medical treatment, dietary counseling, and routine diabetes education.
Active Comparator: Standard Diabetes Care
Participants received standard diabetes care without additional spiritual care intervention.
Behavioral: Standard Diabetes Care
Standard diabetes management provided according to hospital clinical guidelines, including medical treatment, dietary counseling, and routine diabetes education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Resilience
Time Frame: Baseline and post-intervention (4 weeks)
Psychological resilience measured using a validated resilience questionnaire, with higher scores indicating greater resilience.
Baseline and post-intervention (4 weeks)
Psychological Distress
Time Frame: Baseline and post-intervention (4 weeks)
Psychological distress assessed using a standardized psychological distress scale, with higher scores indicating greater distress.
Baseline and post-intervention (4 weeks)
Blood Glucose Level
Time Frame: Baseline and post-intervention (4 Weeks)
Fasting blood glucose level measured in milligrams per deciliter (mg/dL).
Baseline and post-intervention (4 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Noor Huda Mustofa

Investigators

  • Principal Investigator: Faisal Amir, Universitas Noor Huda Mustofa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2024

Primary Completion (Actual)

June 5, 2024

Study Completion (Actual)

July 5, 2024

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC-DMT2-2024-AMM
  • 1853/KEPK/STIKES-NHM/EC/V/2023 (Other Identifier: STIKES Ngudia Husada Madura)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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