Indonesian-Language Application-Based Guided Imagery Therapy for Insomnia and Glycemic Control in Diabetic Patients

NCT ID: NCT07141940

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2025-08-19

Brief Summary

The goal of this clinical trial is to learn if guided imagery therapy using mobile application in Indonesian language can improve sleep quality and lower fasting blood glucose levels in diabetics patients who have problems with their sleep.

The main questions it aims to answer are:

• Can the app-based guided imagery therapy help improve sleep quality in diabetic patients who have trouble sleeping?
• Can the app-based guided imagery therapy help lowering fasting blood glucose in diabetic patients who have trouble sleeping? Researchers will compare app-based guided imagery therapy to education about how to sleep well, to see if the app works to improve sleep quality and lower blood glucose.

Participants will:

• Receive education about how to sleep well
• Use the app 3 times a week for 4 weeks (only for group who receive the app)
• Visit the clinic after 4 weeks for tests

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2); Insomnia Type; Sleep Disorder; Fasting Plasma Glucose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

The participants receive psychoeducation at the enrollment. Then, they were asked to use the Indonesian-language application-based auditory guided imagery therapy 3 times a week for 4 weeks.

Group Type: EXPERIMENTAL

Indonesian-language application-based auditory guided imagery therapy

Intervention Type: OTHER

This study used a mobile application developed by researchers using Indonesian language to deliver an auditory guided imagery therapy

Control Group

The participants receive only psychoeducation at the enrollment.

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: OTHER

Psychoeducation consists of sleep hygiene and relaxation therapy (breathing exercise, progressive muscle relaxation, and guided imagery)

Interventions

Indonesian-language application-based auditory guided imagery therapy

This study used a mobile application developed by researchers using Indonesian language to deliver an auditory guided imagery therapy

Intervention Type: OTHER

Psychoeducation

Psychoeducation consists of sleep hygiene and relaxation therapy (breathing exercise, progressive muscle relaxation, and guided imagery)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients at Endocrinology or Psychosomatic Clinic, Cipto Mangunkusumo Hospital
• Already diagnosed with Diabetes Mellitus
• HbA1c less than 12%
• Insomnia Severity Index more than 8
• Lives in Jakarta, Bogor, Depok, Tangerang, or Bekasi
• Able to understand the Indonesian language well

Exclusion Criteria

• History of amputation or routine hemodialysis
• No device available to connect with the application
• Inability to independently access or use the application
• Inability to perform self-monitoring of blood glucose at home
• Hearing impairment
• Cognitive impairment or intellectual limitations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rudi Putranto

Dr. dr. Rudi Putranto, Sp.PD, K-P.P.M, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rudi Putranto, Internist, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Psychosomatic and Palliative, Department of Internal Medicine, Faculty of Medicine Universitas Indonesia - Cipto Mangunkusumo Hospital

Locations

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

Other Identifiers

RSCM_IPD_PPM_2025.01

Identifier Type: -

Identifier Source: org_study_id