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

NCT07141940 | Completed DMC

• 1 other identifier: RSCM_IPD_PPM_2025.01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Keywords

guided imagery; relaxation therapy; psycoeducation; insomnia; sleep disorders; fasting blood glucose; diabetes mellitus; Indonesian-language; application-based

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index

  4 weeks

• Fasting Plasma Glucose

  4 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Indonesian-language application-based auditory guided imagery therapy

Control Group

ACTIVE COMPARATOR

The participants receive only psychoeducation at the enrollment.

Other: Psychoeducation

Interventions

Indonesian-language application-based auditory guided imagery therapy OTHER

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

Intervention Group

Psychoeducation OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Rudi Putranto, Internist, MPH, PhD

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

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

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: May 6, 2025
• Primary Completion: August 19, 2025
• Study Completion: August 19, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-03

Locations

ID (1)