Type 2 Diabetes Mellitus (T2DM)SC-DMT2NCT07333625
Spiritual Care for Psychological and Glycemic Outcomes in Type 2 Diabetes
A study testing Spiritual Care Program and Standard Diabetes Care in people with Type 2 Diabetes Mellitus (T2DM), run by Universitas Noor Huda Mustofa at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Spiritual Care Program and Standard Diabetes Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Jun 2024to 5 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosed with severe psychiatric disorders
- Having cognitive impairment that interferes with participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Spiritual Care Program, Standard Diabetes Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual Care ProgramBehavioural
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 CareBehavioural
Standard diabetes management provided according to hospital clinical guidelines, including medical treatment, dietary counseling, and routine diabetes education.
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Care Plus Standard Care | Experimental | Participants received standard diabetes care combined with a structured spiritual care program. Receives: Behavioral: Spiritual Care Program; Behavioral: Standard Diabetes Care |
| Standard Diabetes Care | Active comparator | Participants received standard diabetes care without additional spiritual care intervention. Receives: Behavioral: Standard Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Resilience
Psychological resilience measured using a validated resilience questionnaire, with higher scores indicating greater resilience.
Measured: Baseline and post-intervention (4 weeks)
Psychological Distress
Psychological distress assessed using a standardized psychological distress scale, with higher scores indicating greater distress.
Measured: Baseline and post-intervention (4 weeks)
Blood Glucose Level
Fasting blood glucose level measured in milligrams per deciliter (mg/dL).
Measured: Baseline and post-intervention (4 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start2 Jun 2024
- Primary completion5 Jun 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Noor Huda Mustofa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faisal Amir, Universitas Noor Huda Mustofa
- Investigators
- Faisal Amir, Principal investigator, Universitas Noor Huda Mustofa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333625
- Sponsor's protocol ID
- SC-DMT2-2024-AMM
- Other IDs
- 1853/KEPK/STIKES-NHM/EC/V/2023
- Acronym
- SC-DMT2
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23762764
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Spiritual Care Into Type 2 Diabetes Management: Effects on Psychological Resilience, Distress, and Glycemic Control
- ClinicalTrials.gov ID
- NCT07333625
- Acronym / sponsor ID
- SC-DMT2 / SC-DMT2-2024-AMM
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Universitas Noor Huda MustofaUniversity, hospital or other
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiritual Care Plus Standard Care | Experimental | Behavioral: Spiritual Care Program, Behavioral: Standard Diabetes CareParticipants received standard diabetes care combined with a structured spiritual care program. |
| Standard Diabetes Care | Active comparator | Behavioral: Standard Diabetes CareParticipants received standard diabetes care without additional spiritual care intervention. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosed with severe psychiatric disorders
- Having cognitive impairment that interferes with participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiritual Care ProgramA structured spiritual care program integrated into standard diabetes management, including guided spiritual reflection, supportive counseling, and meaning-centered support delivered by trained healthcare providers. | Behavioural | Spiritual Care Plus Standard Care |
| Standard Diabetes CareStandard diabetes management provided according to hospital clinical guidelines, including medical treatment, dietary counseling, and routine diabetes education. | Behavioural | Spiritual Care Plus Standard Care, Standard Diabetes Care |
Primary outcome
Psychological Resilience
Time frame: Baseline and post-intervention (4 weeks)
Psychological resilience measured using a validated resilience questionnaire, with higher scores indicating greater resilience.
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.
Blood Glucose Level
Time frame: Baseline and post-intervention (4 Weeks)
Fasting blood glucose level measured in milligrams per deciliter (mg/dL).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 23762764Koenig HG. Religion, spirituality, and health: the research and clinical implications. ISRN Psychiatry. 2012 Dec 16;2012:278730. doi: 10.5402/2012/278730. Print 2012.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faisal Amir principal investigator
Universitas Noor Huda Mustofa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual Care Program and Standard Diabetes Care in people with Type 2 Diabetes Mellitus (T2DM), run by Universitas Noor Huda Mustofa at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Resilience (time frame: Baseline and post-intervention (4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07333625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.