scholarly journals Light Enhanced Cognitive Behavioural Therapy (CBT+) for Sleep and Fatigue: Study Protocol for a Randomized Controlled Trial during Chemotherapy for Breast Cancer

2020 ◽  
Author(s):  
Helena Rose Bean ◽  
Lesley Stafford ◽  
Ruth Little ◽  
Justine Diggens ◽  
Maria Ftanou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Mental Health ◽  
Randomised Controlled Trial ◽  
Sleep Disturbance ◽  
Cognitive Behavioural Therapy ◽  
Sleep Disturbances ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Randomised Controlled

Abstract Background: Women with breast cancer experience a significantly higher prevalence of sleep disturbances and insomnia compared with the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment of sleep in this population is not part of routine care, and often is managed inadequately. This randomised controlled trial will examine the combined effects of Cognitive Behavioural Therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue, and mental health. Method/design: Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne Australia will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 minutes each morning for the six-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the six weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT; and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure. Data will also be collected on potential treatment moderators and mechanisms, and adherence to treatment. There will be three-month follow-up measurements of fatigue, sleep-related impairment, sleep disturbance, depression, and anxiety. Discussion: This is the first randomised controlled trial to combine CBT and BLT for the treatment of sleep disturbances in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy translation. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12618001255279. Retrospectively registered on: 25/07/2018, recruitment began: 24/07/2018.

scholarly journals Light Enhanced Cognitive Behavioural Therapy (CBT+) for Sleep and Fatigue: Study Protocol for a Randomized Controlled Trial during Chemotherapy for Breast Cancer

2019 ◽  
Author(s):  
Helena Rose Bean ◽  
Lesley Stafford ◽  
Ruth Little ◽  
Justine Diggens ◽  
Maria Ftanou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Mental Health ◽  
Randomised Controlled Trial ◽  
Sleep Disturbance ◽  
Cognitive Behavioural Therapy ◽  
Sleep Disturbances ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Randomised Controlled

Abstract Background: Women with breast cancer experience a significantly higher prevalence of sleep disturbances and insomnia compared with the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment of sleep in this population is not part of routine care, and often is managed inadequately. This randomised controlled trial will examine the combined effects of Cognitive Behavioural Therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue, and mental health. Method/design: Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne Australia will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 minutes each morning for the six-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the six weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT; and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure. Data will also be collected on potential treatment moderators and mechanisms, and adherence to treatment. There will be three-month follow-up measurements of fatigue, sleep-related impairment, sleep disturbance, depression, and anxiety. Discussion: This is the first randomised controlled trial to combine CBT and BLT for the treatment of sleep disturbances in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy translation. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12618001255279. Retrospectively registered on: 25/07/2018, recruitment began: 24/07/2018.

scholarly journals Light Enhanced Cognitive Behavioural Therapy (CBT+) for Sleep and Fatigue: Study Protocol for a Randomized Controlled Trial during Chemotherapy for Breast Cancer

2019 ◽  
Author(s):  
Helena Rose Bean ◽  
Lesley Stafford ◽  
Ruth Little ◽  
Justine Diggens ◽  
Maria Ftanou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Mental Health ◽  
Sleep Disturbance ◽  
Cognitive Behavioural Therapy ◽  
Sleep Disturbances ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Measure Data ◽  
Cognitive Behavioural ◽  
Randomised Controlled

Abstract Background Women with breast cancer experience a significantly higher prevalence of sleep disturbances and insomnia compared with the general population. The experience of persistent sleep disturbance places breast cancer patients at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment of sleep in this population is not standard and is often inadequately managed. This randomised controlled study will examine the effects of both Cognitive Behavioural Therapy for insomnia and sleep (CBT-I) and bright light therapy (BL) on the symptoms of insomnia, fatigue and mental health. Method/design Women diagnosed with breast cancer who are or will be receiving intravenous chemotherapy treatment at a major metropolitan cancer centre in Melbourne will be recruited (n=80). Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible participants will be randomised to the CBT+ intervention (CBT and BL) or relaxation audio enhanced treatment as usual (TAU+). The intervention group will receive one face-to-face session on sleep strategies, one telephone call, and seven email packages containing CBT-I based information and strategies. Participants will also wear Luminette light glasses for 20 minutes each morning for the six-week duration of the intervention. TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the 6 weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT; and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure. Data will also be collected on potential treatment moderators and mechanisms, and adherence to treatment. There will be 3-month follow-up measurements of fatigue, sleep-related impairment, sleep disturbance, depression, and anxiety. Discussion This is the first randomised controlled trial to combine CBT and BL for the treatment of sleep disturbances in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy dissemination.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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