Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis
Recruitment status was Recruiting
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Purpose
Background
More than 50% of dialysis patients experience sleep disturbances that significantly affect quality of life, overall morbidity, and mortality. There is no effective therapy except hypnotics, which have notable side effects. Cognitive-behavioral therapy (CBT) is effective for treating peritoneal dialysis (PD) patients, the elderly and cancer patients with chronic insomnia, but its effectiveness has never been reported in hemodialysis (HD) patients and its impacts on the inflammatory cytokines, oxidative stress and autonomic dysfunction in this population are unknown. The investigators investigated the effectiveness of CBT in HD patients by assessing changes in sleep quality, inflammatory cytokines, oxidative stress and autonomic dysfunction.
Objects
This study is designed to assess the effectiveness of CBT on sleep disturbance in insomnias HD patients. The investigators also evaluate the impacts of CBT on the inflammatory cytokines, oxidative stress and autonomic dysfunction in these insomnias HD patients.
Methods
The investigators expected to recruit 80 insomnias HD patients undergoing maintenance HD for more than 3 months for the investigation. Besides, 40 HD patients without sleep disturbance will be recruited for comparison. Patients with sleep disturbance (N=80) was randomized to either intervention (CBT) group (N=40) or control group (N=40). Participants in CBT group will receive 6-week CBT while in control group and patients without sleep disturbance only receive sleep hygiene education. The subjects were assessed at baseline and after the intervention with the Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Beck depression index (BDI) and the International Index of Erectile Function (IIEF) for men and the Index of Female Sexual Function (IFSF) for women; and inflammatory cytokines (serum IL-1β, IL-18, and TNF-α levels), oxidative stress (TBARS, Total antioxidant status and serum 8-OHdG) and autonomic dysfunction (Baroreflex sensitivity, BRS) were measured.
Expected results
The investigators expect that CBT can improve the sleep disturbance in HD patients and may change the inflammatory cytokines, oxidative stress and autonomic dysfunction after the intervention in insomnias HD patients.
| Condition | Intervention |
|---|---|
|
Insomnia Depression Inflammation |
Behavioral: cognitive behavioral therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis and Its Impacts on Their Inflammatory Cytokines, Oxidative Stress and Autonomic Dysfunction |
- improvement of sleep disturbance/depression/anxiety [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Changes of inflammatory cytokines/oxidative stress [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: cognitive behaviorial therapy |
Behavioral: cognitive behavioral therapy
Participants who randomized into the CBT group will receive 18 30-minute tri-weekly treatment sessions of CBT during the 6-week period
Other Name: cognitive behavioral therpy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- under maintenance hemodialysis for more than 6 months
- subjective sleep complaints and screening PSQI ≥ 5
Exclusion Criteria:
- active medical condition (hospitalization/surgery)
- active malignancy
- active infection
Contacts and Locations| Contact: Hung-Yuan Chen, M.D | 886-2-89667000 ext 1163 | alexander220tw@yahoo.com |
| Taiwan | |
| Far Eastern Memorial Hospital | Recruiting |
| Taipei, Taiwan, 220 | |
| Contact: Hung-Yuan Chen, M.D 886-2-89667000 ext 1163 alexander220tw@yahoo.com | |
| Principal Investigator: Hung-Yuan Chen, M.D | |
| Principal Investigator: | Hung-Yuan Chen, M.D | Far Eastern Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Far Eastern Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01159197 History of Changes |
| Other Study ID Numbers: | FEMH-97-D-093 |
| Study First Received: | May 24, 2010 |
| Last Updated: | August 4, 2010 |
| Health Authority: | Taiwan: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Far Eastern Memorial Hospital:
|
sleep disturbance cognitive behavioral therapy inflammation oxidative stress hemodialysis |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Inflammation Sleep Disorders Dyssomnias Parasomnias Behavioral Symptoms |
Mood Disorders Mental Disorders Pathologic Processes Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013