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
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01159197
First received: May 24, 2010
Last updated: August 4, 2010
Last verified: November 2008
  Purpose

Background

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.

Objects

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.

Methods

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
Insomnia
Depression
Inflammation
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159197

Contacts
Contact: Hung-Yuan Chen, M.D 886-2-89667000 ext 1163 alexander220tw@yahoo.com

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Taipei, Taiwan, 220
Contact: Hung-Yuan Chen, M.D    886-2-89667000 ext 1163    alexander220tw@yahoo.com   
Principal Investigator: Hung-Yuan Chen, M.D         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Hung-Yuan Chen, M.D Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov 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
inflammation
oxidative stress
hemodialysis

Additional relevant MeSH terms:
Depression
Depressive Disorder
Inflammation
Sleep Disorders
Dyssomnias
Parasomnias
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014