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

NCT ID: NCT00155441

Last Updated: 2007-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30

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.

Conditions

Sleep Disorders; Kidney Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cognitive-behavioral therapy

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Tun-Jun Tsai, Ph.D., M.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Department of Internal Medicine, National Taiwan University

Locations

National Taiwan University Hospital

Dawan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tun-Jun Tsai, Ph.D., M.D

Role: CONTACT

paul@ha.mc.ntu.edu.tw

+886-23123456 ext. 3953

Facility Contacts

Tun-Jun Tsai, Ph.D., M.D

Role: primary

paul@ha.mc.ntu.edu.tw

+886-23123456 ext. 3953

References

Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

Reference Type: DERIVED

PMID: 37651553 (View on PubMed)

Other Identifiers

9461700509

Identifier Type: -

Identifier Source: org_study_id