Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT00155441|
Recruitment Status : Unknown
Verified May 2005 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 12, 2005
Last Update Posted : January 9, 2007
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disorders Kidney Diseases||Behavioral: cognitive-behavioral therapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients|
|Study Start Date :||June 2005|
- Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
- The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155441
|Contact: Tun-Jun Tsai, Ph.D., M.D||+886-23123456 ext email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taiwan, Taiwan, 100|
|Contact: Tun-Jun Tsai, Ph.D., M.D +886-23123456 ext 3953 firstname.lastname@example.org|
|Principal Investigator: Tun-Jun Tsai, Ph.D., M.D.|
|Principal Investigator:||Tun-Jun Tsai, Ph.D., M.D.||Division of Nephrology, Department of Internal Medicine, National Taiwan University|