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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Disorders, Kidney Diseases

Intervention / Treatment
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* Behavioral: cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: cognitive-behavioral therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Check Pittsburgh Sleep Quality Index and restless leg syndrome index: in 1st and 3rd months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hematologic, biochemical markers, and peritoneal function in 1st and 3rd months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep disorder, peritoneal dialysis, cognitive-behavioral therapy, sleep disorder:C23.888.592.796, peritoneal dialysis: F03.870.664