Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients
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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 |
- 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
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2005 |
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 |
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| Contact: Tun-Jun Tsai, Ph.D., M.D | +886-23123456 ext 3953 | paul@ha.mc.ntu.edu.tw |
| 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. | |
| 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 June 13, 2013