Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Information provided by:
Far Eastern Memorial Hospital Identifier:
First received: May 24, 2010
Last updated: August 4, 2010
Last verified: November 2008


More than 50% of dialysis patients experience sleep disturbances that significantly affect quality of life, overall morbidity, and mortality. There is no effective therapy except hypnotics, which have notable side effects. Cognitive-behavioral therapy (CBT) is effective for treating peritoneal dialysis (PD) patients, the elderly and cancer patients with chronic insomnia, but its effectiveness has never been reported in hemodialysis (HD) patients and its impacts on the inflammatory cytokines, oxidative stress and autonomic dysfunction in this population are unknown. The investigators investigated the effectiveness of CBT in HD patients by assessing changes in sleep quality, inflammatory cytokines, oxidative stress and autonomic dysfunction.


This study is designed to assess the effectiveness of CBT on sleep disturbance in insomnias HD patients. The investigators also evaluate the impacts of CBT on the inflammatory cytokines, oxidative stress and autonomic dysfunction in these insomnias HD patients.


The investigators expected to recruit 80 insomnias HD patients undergoing maintenance HD for more than 3 months for the investigation. Besides, 40 HD patients without sleep disturbance will be recruited for comparison. Patients with sleep disturbance (N=80) was randomized to either intervention (CBT) group (N=40) or control group (N=40). Participants in CBT group will receive 6-week CBT while in control group and patients without sleep disturbance only receive sleep hygiene education. The subjects were assessed at baseline and after the intervention with the Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Beck depression index (BDI) and the International Index of Erectile Function (IIEF) for men and the Index of Female Sexual Function (IFSF) for women; and inflammatory cytokines (serum IL-1β, IL-18, and TNF-α levels), oxidative stress (TBARS, Total antioxidant status and serum 8-OHdG) and autonomic dysfunction (Baroreflex sensitivity, BRS) were measured.

Expected results

The investigators expect that CBT can improve the sleep disturbance in HD patients and may change the inflammatory cytokines, oxidative stress and autonomic dysfunction after the intervention in insomnias HD patients.

Condition Intervention
Behavioral: cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis and Its Impacts on Their Inflammatory Cytokines, Oxidative Stress and Autonomic Dysfunction

Resource links provided by NLM:

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • improvement of sleep disturbance/depression/anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of inflammatory cytokines/oxidative stress [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive behaviorial therapy Behavioral: cognitive behavioral therapy
Participants who randomized into the CBT group will receive 18 30-minute tri-weekly treatment sessions of CBT during the 6-week period
Other Name: cognitive behavioral therpy

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • under maintenance hemodialysis for more than 6 months
  • subjective sleep complaints and screening PSQI ≥ 5

Exclusion Criteria:

  • active medical condition (hospitalization/surgery)
  • active malignancy
  • active infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01159197

Contact: Hung-Yuan Chen, M.D 886-2-89667000 ext 1163

Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 220
Contact: Hung-Yuan Chen, M.D    886-2-89667000 ext 1163   
Principal Investigator: Hung-Yuan Chen, M.D         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Principal Investigator: Hung-Yuan Chen, M.D Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital Identifier: NCT01159197     History of Changes
Other Study ID Numbers: FEMH-97-D-093
Study First Received: May 24, 2010
Last Updated: August 4, 2010
Health Authority: Taiwan: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Far Eastern Memorial Hospital:
sleep disturbance
cognitive behavioral therapy
oxidative stress

Additional relevant MeSH terms:
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms processed this record on November 25, 2015