Cognitive-Behavioral Therapy for Sleep Disturbance in Patients Undergoing Hemodialysis

NCT01159197 | Unknown DMC

• 1 other identifier: FEMH-97-D-093
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Insomnia; Depression; Inflammation

Keywords

sleep disturbance; cognitive behavioral therapy; inflammation; oxidative stress; hemodialysis

Outcome Measures

Primary Outcomes (1)

• improvement of sleep disturbance/depression/anxiety

  6 weeks

Secondary Outcomes (1)

• Changes of inflammatory cytokines/oxidative stress

  6 weeks

Study Arms (1)

cognitive behaviorial therapy

EXPERIMENTAL

Behavioral: cognitive behavioral therapy

Interventions

cognitive behavioral therapy BEHAVIORAL

Participants who randomized into the CBT group will receive 18 30-minute tri-weekly treatment sessions of CBT during the 6-week period

Also known as: cognitive behavioral therpy

cognitive behaviorial therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• under maintenance hemodialysis for more than 6 months
• subjective sleep complaints and screening PSQI ≥ 5

You may not qualify if:

• active medical condition (hospitalization/surgery)
• active malignancy
• active infection

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, Taiwan, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression; Inflammation; Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hung-Yuan Chen, M.D

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Yuan Chen, M.D

CONTACT

886-2-89667000; alexander220tw@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: July 9, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 6, 2010

Record last verified: 2008-11

Locations

TW (1)