Clinical trial NCT00155441: Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
Official title: Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sleep Disorders
Kidney Diseases
Keywords: sleep disorder
peritoneal dialysis
cognitive-behavioral therapy
sleep disorder:C23.888.592.796
peritoneal dialysis: F03.870.664
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Far Eastern Memorial Hospital
First posted: 2005-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months
Secondary outcomes:
measure: The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, National Taiwan University
name: Tun-Jun Tsai, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: