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NCT Number: NCT07333625

Spiritual Care for Psychological and Glycemic Outcomes in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSU Anna Medika Madura

Bangkalan, East Java, 69116, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard Diabetes Care

Behavioral

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

Primary outcomes

  1. Psychological Resilience

    Time frame: Baseline and post-intervention (4 weeks)

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

  2. 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.

  3. Blood Glucose Level

    Time frame: Baseline and post-intervention (4 Weeks)

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

Sponsors and collaborators

Lead sponsor

Universitas Noor Huda Mustofa

Other

Registry information

Official study title

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

Acronym: SC-DMT2

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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