Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155441
First received: September 8, 2005
Last updated: January 8, 2007
Last verified: May 2005
  Purpose

Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients. This study tries to elucidate its therapeutic effect on the sleep disturbance in chronic peritoneal dialysis patients.


Condition Intervention Phase
Sleep Disorders
Kidney Diseases
Behavioral: cognitive-behavioral therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months

Secondary Outcome Measures:
  • The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months

Estimated Enrollment: 30
Study Start Date: June 2005
Detailed Description:

Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. So many factors interfering the sleep of these patients, however, there is no effective therapy for them except some drugs, such as hypnotics or anxiolytics. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically and it contains three therapeutic domains including stimulus control, sleep restriction therapy, and relaxation training. It has been proven to be beneficial in improving sleep pattern in chronic insomnia and cancer patients and alcoholism. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients, however, there is no clinical evidence revealing its effectiveness upon sleep disorders in hemodialysis and peritoneal dialysis patients. Our study tries to elucidate the therapeutic effect of cognitive-behavioral therapy on the sleep disturbance in chronic peritoneal dialysis patients.

We will perform cognitive-behavioral therapy to eligible peritoneal dialysis patients and evaluate the sleep condition before and after the therapy. Moreover, clinical conditions, biochemical and hematological parameters, inflammatory mediators in blood will be measured at baseline, before and after therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing peritoneal dialysis (PD) for at least 3 months
  • Older than 18 years
  • Have sleep disturbance subjectively

Exclusion Criteria:

  • Unstable clinical conditions or evidence of malignancy
  • Pregnancy
  • Participation in another study that would interfere with the outcome of this study
  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 ClinicalTrials.gov identifier: NCT00155441

Contacts
Contact: Tun-Jun Tsai, Ph.D., M.D +886-23123456 ext 3953 paul@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taiwan, Taiwan, 100
Contact: Tun-Jun Tsai, Ph.D., M.D    +886-23123456 ext 3953    paul@ha.mc.ntu.edu.tw   
Principal Investigator: Tun-Jun Tsai, Ph.D., M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Tun-Jun Tsai, Ph.D., M.D. Division of Nephrology, Department of Internal Medicine, National Taiwan University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00155441     History of Changes
Other Study ID Numbers: 9461700509
Study First Received: September 8, 2005
Last Updated: January 8, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
sleep disorder
peritoneal dialysis
cognitive-behavioral therapy
sleep disorder:C23.888.592.796
peritoneal dialysis: F03.870.664

Additional relevant MeSH terms:
Kidney Diseases
Sleep Disorders
Dyssomnias
Parasomnias
Urologic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014