Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis

Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020). Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Unruh, Mark [verfasserIn] Cukor, Daniel [verfasserIn] Rue, Tessa [verfasserIn] Abad, Kashif [verfasserIn] Roumelioti, Maria-Eleni [verfasserIn] McCurry, Susan M. [verfasserIn] Heagerty, Patrick [verfasserIn] Mehrotra, Rajnish [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2020

Schlagwörter:	Insomnia Hemodialysis Cognitive behavioral therapy Trazodone Actigraphy Telehealth Computer-based telephone interview

Übergeordnetes Werk:	Enthalten in: BMC nephrology - London : BioMed Central, 2000, 21(2020), 1 vom: 20. Okt.
Übergeordnetes Werk:	volume:21 ; year:2020 ; number:1 ; day:20 ; month:10

Links:	Volltext

DOI / URN:	10.1186/s12882-020-02107-x

Katalog-ID:	SPR041457897

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520			\|a Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).
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allfields	10.1186/s12882-020-02107-x doi (DE-627)SPR041457897 (SPR)s12882-020-02107-x-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Unruh, Mark verfasserin aut Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020). Insomnia (dpeaa)DE-He213 Hemodialysis (dpeaa)DE-He213 Cognitive behavioral therapy (dpeaa)DE-He213 Trazodone (dpeaa)DE-He213 Actigraphy (dpeaa)DE-He213 Telehealth (dpeaa)DE-He213 Computer-based telephone interview (dpeaa)DE-He213 Cukor, Daniel verfasserin aut Rue, Tessa verfasserin aut Abad, Kashif verfasserin aut Roumelioti, Maria-Eleni verfasserin aut McCurry, Susan M. verfasserin aut Heagerty, Patrick verfasserin aut Mehrotra, Rajnish verfasserin aut Enthalten in BMC nephrology London : BioMed Central, 2000 21(2020), 1 vom: 20. Okt. (DE-627)326643672 (DE-600)2041348-8 1471-2369 nnns volume:21 year:2020 number:1 day:20 month:10 https://dx.doi.org/10.1186/s12882-020-02107-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 20 10
spelling	10.1186/s12882-020-02107-x doi (DE-627)SPR041457897 (SPR)s12882-020-02107-x-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Unruh, Mark verfasserin aut Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020). Insomnia (dpeaa)DE-He213 Hemodialysis (dpeaa)DE-He213 Cognitive behavioral therapy (dpeaa)DE-He213 Trazodone (dpeaa)DE-He213 Actigraphy (dpeaa)DE-He213 Telehealth (dpeaa)DE-He213 Computer-based telephone interview (dpeaa)DE-He213 Cukor, Daniel verfasserin aut Rue, Tessa verfasserin aut Abad, Kashif verfasserin aut Roumelioti, Maria-Eleni verfasserin aut McCurry, Susan M. verfasserin aut Heagerty, Patrick verfasserin aut Mehrotra, Rajnish verfasserin aut Enthalten in BMC nephrology London : BioMed Central, 2000 21(2020), 1 vom: 20. Okt. (DE-627)326643672 (DE-600)2041348-8 1471-2369 nnns volume:21 year:2020 number:1 day:20 month:10 https://dx.doi.org/10.1186/s12882-020-02107-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 20 10
allfields_unstemmed	10.1186/s12882-020-02107-x doi (DE-627)SPR041457897 (SPR)s12882-020-02107-x-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Unruh, Mark verfasserin aut Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020). Insomnia (dpeaa)DE-He213 Hemodialysis (dpeaa)DE-He213 Cognitive behavioral therapy (dpeaa)DE-He213 Trazodone (dpeaa)DE-He213 Actigraphy (dpeaa)DE-He213 Telehealth (dpeaa)DE-He213 Computer-based telephone interview (dpeaa)DE-He213 Cukor, Daniel verfasserin aut Rue, Tessa verfasserin aut Abad, Kashif verfasserin aut Roumelioti, Maria-Eleni verfasserin aut McCurry, Susan M. verfasserin aut Heagerty, Patrick verfasserin aut Mehrotra, Rajnish verfasserin aut Enthalten in BMC nephrology London : BioMed Central, 2000 21(2020), 1 vom: 20. Okt. (DE-627)326643672 (DE-600)2041348-8 1471-2369 nnns volume:21 year:2020 number:1 day:20 month:10 https://dx.doi.org/10.1186/s12882-020-02107-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 20 10
allfieldsGer	10.1186/s12882-020-02107-x doi (DE-627)SPR041457897 (SPR)s12882-020-02107-x-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Unruh, Mark verfasserin aut Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020). Insomnia (dpeaa)DE-He213 Hemodialysis (dpeaa)DE-He213 Cognitive behavioral therapy (dpeaa)DE-He213 Trazodone (dpeaa)DE-He213 Actigraphy (dpeaa)DE-He213 Telehealth (dpeaa)DE-He213 Computer-based telephone interview (dpeaa)DE-He213 Cukor, Daniel verfasserin aut Rue, Tessa verfasserin aut Abad, Kashif verfasserin aut Roumelioti, Maria-Eleni verfasserin aut McCurry, Susan M. verfasserin aut Heagerty, Patrick verfasserin aut Mehrotra, Rajnish verfasserin aut Enthalten in BMC nephrology London : BioMed Central, 2000 21(2020), 1 vom: 20. Okt. (DE-627)326643672 (DE-600)2041348-8 1471-2369 nnns volume:21 year:2020 number:1 day:20 month:10 https://dx.doi.org/10.1186/s12882-020-02107-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 20 10
allfieldsSound	10.1186/s12882-020-02107-x doi (DE-627)SPR041457897 (SPR)s12882-020-02107-x-e DE-627 ger DE-627 rakwb eng 610 ASE 44.00 bkl Unruh, Mark verfasserin aut Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis 2020 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020). Insomnia (dpeaa)DE-He213 Hemodialysis (dpeaa)DE-He213 Cognitive behavioral therapy (dpeaa)DE-He213 Trazodone (dpeaa)DE-He213 Actigraphy (dpeaa)DE-He213 Telehealth (dpeaa)DE-He213 Computer-based telephone interview (dpeaa)DE-He213 Cukor, Daniel verfasserin aut Rue, Tessa verfasserin aut Abad, Kashif verfasserin aut Roumelioti, Maria-Eleni verfasserin aut McCurry, Susan M. verfasserin aut Heagerty, Patrick verfasserin aut Mehrotra, Rajnish verfasserin aut Enthalten in BMC nephrology London : BioMed Central, 2000 21(2020), 1 vom: 20. Okt. (DE-627)326643672 (DE-600)2041348-8 1471-2369 nnns volume:21 year:2020 number:1 day:20 month:10 https://dx.doi.org/10.1186/s12882-020-02107-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 44.00 ASE AR 21 2020 1 20 10
language	English
source	Enthalten in BMC nephrology 21(2020), 1 vom: 20. Okt. volume:21 year:2020 number:1 day:20 month:10
sourceStr	Enthalten in BMC nephrology 21(2020), 1 vom: 20. Okt. volume:21 year:2020 number:1 day:20 month:10
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Insomnia Hemodialysis Cognitive behavioral therapy Trazodone Actigraphy Telehealth Computer-based telephone interview
dewey-raw	610
isfreeaccess_bool	true
container_title	BMC nephrology
authorswithroles_txt_mv	Unruh, Mark @@aut@@ Cukor, Daniel @@aut@@ Rue, Tessa @@aut@@ Abad, Kashif @@aut@@ Roumelioti, Maria-Eleni @@aut@@ McCurry, Susan M. @@aut@@ Heagerty, Patrick @@aut@@ Mehrotra, Rajnish @@aut@@
publishDateDaySort_date	2020-10-20T00:00:00Z
hierarchy_top_id	326643672
dewey-sort	3610
id	SPR041457897
language_de	englisch
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One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. 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spellingShingle	Unruh, Mark ddc 610 bkl 44.00 misc Insomnia misc Hemodialysis misc Cognitive behavioral therapy misc Trazodone misc Actigraphy misc Telehealth misc Computer-based telephone interview Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis
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topic_title	610 ASE 44.00 bkl Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis Insomnia (dpeaa)DE-He213 Hemodialysis (dpeaa)DE-He213 Cognitive behavioral therapy (dpeaa)DE-He213 Trazodone (dpeaa)DE-He213 Actigraphy (dpeaa)DE-He213 Telehealth (dpeaa)DE-He213 Computer-based telephone interview (dpeaa)DE-He213
topic	ddc 610 bkl 44.00 misc Insomnia misc Hemodialysis misc Cognitive behavioral therapy misc Trazodone misc Actigraphy misc Telehealth misc Computer-based telephone interview
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title	Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis
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title_full	Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis
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author_browse	Unruh, Mark Cukor, Daniel Rue, Tessa Abad, Kashif Roumelioti, Maria-Eleni McCurry, Susan M. Heagerty, Patrick Mehrotra, Rajnish
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title_sort	sleep-hd trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis
title_auth	Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis
abstract	Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).
abstractGer	Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).
abstract_unstemmed	Background Patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD) experience many distressing symptoms. One frequently reported symptom is insomnia. There are unique issues about HD treatments and schedules that disrupt regular sleep/wake routines and possibly contribute to the high severity of insomnia. Despite evidence for broad-ranging health effects of insomnia, very few clinical trials have tested the efficacy of treatments for HD patients. Cognitive-behavioral therapy for insomnia (CBT-I) is a recommended first-line therapy but largely inaccessible to HD patients in the United States, partly because they commit considerable amounts of time to thrice-weekly dialysis treatments. Another important reason could be the logistical and reimbursement challenges associated with providing behavioral health care at the dialysis center. CBT-I delivered by telehealth can overcome barriers to access, but its efficacy has never been rigorously tested for these patients. Pharmacotherapy is the most widely used treatment for insomnia; however, some drugs presently used are unsafe as they are associated with a higher risk for death for HD patients (benzodiazepines and zolpidem-like drugs). The efficacy and safety of other medications (trazodone) for the treatment of insomnia has never been tested for patients treated with HD. Methods This trial tests the short- and long-term comparative effectiveness of 6-week treatment with telehealth CBT-I, trazodone, or medication placebo. This will be accomplished with a randomized controlled trial (RCT) in which 126 participants treated with HD in community-based dialysis facilities with chronic insomnia will be assigned 1:1:1 to telehealth CBT-I, trazodone, or medication placebo, respectively; short-term effectiveness of each treatment arm will be determined at the end of 6-weeks of treatment and long-term effectiveness at 25-weeks. The primary and secondary patient-reported outcomes will be assessed with computer-based telephone interviewing by research scientists blinded to treatment assignment; additional secondary outcomes will be assessed by participant interview and actigraphy. Discussion This clinical RCT will provide the first evidence for the comparative effectiveness of two distinct approaches for treating chronic insomnia and other patient-reported outcomes for patients receiving maintenance HD. Trial registration NCT03534284 May 23, 2018. SLEEP-HD Protocol Version: 1.3.4 (7/22/2020).
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title_short	Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis
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Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis

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