Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03713996 · ClinicalTrials.gov registry record · NA
The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes
A NA study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03713996: Completed NA study, sponsored by University of Kansas Medical Center.
NCT03713996 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03713996, a NA study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care behavior (DSCB) is important in attaining and maintaining glycemic control, which worsens as a result of fatigue. People with insomnia usually suffer from fatigue and inconstant sleep schedule, which negatively influence quality of life. However, the additive effect of behavioral sleep intervention on diabetes outcomes and health status in people with T2D is unknown. Therefore, The overall purpose of this study is to investigate the impact of both insomnia symptoms and CBT-I on people with T2D. The central hypotheses are that people with T2D and insomnia symptoms will have worse sleep, diabetes measures and self-reported outcomes compared to people with T2D only, which might be adjusted with CBT-I.
Primary Outcome
The Insomnia Severity Index is a self-report measure designed to evaluate the nature, severity, and impact of insomnia.Seven-items assess severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress due to the sleep difficulties.This is self-reported seven items on a five-point Likert scale from zero (not at all satisfied) to four (very much
Interventions
- OTHER Health Education
- BEHAVIORAL Cognitive behavioral therapy for insomnia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-01-16 |
| Est. Completion | 2019-06-01 |
| Phase | NA |
What the finished NCT03713996 record still lists
NCT03713996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Health Education is the first listed.
NCT03713996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03713996 about?
NCT03713996 is a clinical study titled "The Effect of Cognitive Behavioral Therapy for Insomnia on Type 2 Diabetes Health Outcomes". Insomnia is a common sleep disorder, with three main symptoms: difficulty in initiating sleep, difficulty in maintaining sleep, and/or waking up early without ability to return to sleep. Insomnia can contribute to metabolic dysfunction, which can lead to type 2 diabetes (T2D). Diabetes self-care beh...
What is the current status of trial NCT03713996?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2019-01-16. Estimated completion is 2019-06-01.
What interventions are being tested in trial NCT03713996?
The interventions under investigation include: Health Education (OTHER), Cognitive behavioral therapy for insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT03713996?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03713996's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI