Leanne Fleming

Randomized Controlled Clinical Effectiveness Trial of Cognitive Behavior Therapy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer

PURPOSE Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. PATIENTS AND METHODS Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. RESULTS CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. CONCLUSION CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.

The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder

Objective Describe the development and psychometric validation of a brief scale (the Sleep Condition Indicator (SCI)) to evaluate insomnia disorder in everyday clinical practice. Design The SCI was evaluated across five study samples. Content validity, internal consistency and concurrent validity were investigated. Participants 30 941 individuals (71% female) completed the SCI along with other descriptive demographic and clinical information. Setting Data acquired on dedicated websites. Results The eight-item SCI (concerns about getting to sleep, remaining asleep, sleep quality, daytime personal functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep) had robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index and Insomnia Severity Index. A two-item short-form (SCI-02: nights per week having a sleep problem, extent troubled by poor sleep), derived using linear regression modelling, correlated strongly with the SCI total score (r=0.90). Conclusions The SCI has potential as a clinical screening tool for appraising insomnia symptoms against Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

The development and impact of insomnia on cancer survivors: a qualitative analysis.

Objectives: To conduct the first qualitative analysis of the development and impact of insomnia on a cohort of cancer survivors.

Does cognitive behaviour therapy for insomnia reduce clinical levels of fatigue, anxiety and depression in cancer patients?

This secondary analysis of data from a randomised controlled trial explores associations between common symptom clusters and evaluates pre‐treatment to post‐treatment changes in clinical levels of these symptoms following cognitive behaviour therapy for insomnia (CBT‐I).

The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

Summary Background Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. Methods We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. Findings Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohens d=1·11; p<0·0001), paranoia (−2·22, −2·98 to −1·45, Cohens d=0·19; p<0·0001), and hallucinations (−1·58, −1·98 to −1·18, Cohens d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. Interpretation To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. Funding Wellcome Trust.

Caregiver strain following critical care discharge: An exploratory evaluation

OBJECTIVE The objective of this exploratory evaluation was to understand the impact of critical care survivorship on caregivers. DESIGN Family members who attended a quality improvement initiative within our critical care unit were asked to complete 4 questionnaires. SETTING The setting for this study was a 20-bedded mixed critical care unit in a large teaching hospital in Scotland. Data were collected as a part of an evaluation of a quality improvement initiative. PARTICIPANTS Thirty-six carers completed the questionnaire set. MEASUREMENTS AND MAIN RESULTS A total of 53% of caregivers suffered significant strain. Poor quality of life in the patient was significantly associated with higher caregiver strain (P= .006). Anxiety was present in 69% of caregivers. Depression was present in 56% of caregivers, with a significant association between carer strain and depression (P< .001). Those caregivers who were defined as being strained also had significantly higher Insomnia Severity Index scores than those without carers strain (P= .007). CONCLUSION This evaluation has demonstrated that there is a significant burden for caregivers of critical care survivors. Furthermore, they reported high levels of posttraumatic stress disorder, anxiety, depression, and insomnia. Future work on rehabilitation from critical care should focus on the inclusion of caregivers.

'CBT-I in Cancer: We Know It Works, so Why Are We Waiting?'

Insomnia is one of the most frequently reported and debilitating difficulties associated with cancer. Recent decades have seen a move from pharmacological interventions for insomnia, to non-pharmacological, cognitive behavioural therapies (CBT-I). Numerous clinical trials have established the effectiveness of CBT-I in the general population and more recently, in those with insomnia associated with cancer. However, despite these promising outcomes, the availability of such therapies remains limited across cancer services. Recent years have seen developments to widen access to CBT-I, including the use of internet-based resources. Such developments may offer a useful means of overcoming the availability and access issues of CBT-I for those with insomnia associated with cancer.

Information processing bias in insomnia: research evidence and implications for therapy

Objective: Does snoring during pregnancy influence development of pre-eclampsia?Method: Five hundred and three pregnant women were presented a questionnaire concerning snoring, daytime sleepiness a ...withdrawn O141 Sleep-wake cycle in ballet dancers M. GLOS, T. PENZEL, J. STRAUCH, C. THEOBALD and I. FIETZE Interdisciplinary Center of Sleep Medicine, Charité-Universitaetsmedizin Berlin, Berlin, Germany and Staatsballett Berlin, Berlin, Germany Introduction: Ballet dancers are top athletes and artists with extreme demands on their body and intellectual functions. In this group a normal work schedule on a weekly basis is absent and moreover, half of the week working days last until late evenings. Methods: We investigated the sleep-wake cycle over a period of three months prior to a premiere of a new performance by using actigraphy in 28 (17w, 11 m) ballet dancers (mean age 27 5 years, BMI 19 2) of the ‘‘Staatsballett Berlin’’, a big independent ballet institution of the three institutionalized opera houses in Berlin, Germany. Before starting the actigraphy recording (Actiwatch, Cambridge Neurotechnology Ltd, Cambridge, UK) which was accompanied by filling in activity diaries and sleep logs on a daily basis, a physical examination as well as a sleep medical examination and ambulatory polygraphy (Embletta PDS, Embla Systems, Broomfield, CO, USA) was performed. Results: Out of the 28 ballet dancers who were included, 24 of them completed the study after three months. Altogether we found a regular sleep-wake cycle but no circaseptan rhythm in this population. In addition a delayed sleep phase was predominant. In the course of three month the sleep efficacy (SE) was reduced significantly (82 to 77 percent, Po0.01) without changes in the amount of movements and total sleep time (TST) during the night. These findings were independent of the gender of the ballet dancers. The parameters SE and TST are generally lower than in the general age matched German population. These results were accompanied by diminished mental health scores (SF12 questionnaire) and diminished concentration capabilities (d2 test). Conclusion: The preparation time of a new performance in the course of three month caused additional stress in the investigated ballet dancers which was apparent in a diminished sleep quality. In order to guarantee a good status of health and the high degree of physical and mental capability a good management of rest and a activity is needed. As a consequence a dedicated room for rest has been installed at the opera for the ballet dancers. r 2008 European Sleep Research Society, JSR 17 (Suppl. 1), 1–271 Spotlight on Circadian Clock Works On and Off Stage 81

Psychological effects of cognitive behaviour therapy (CBT) for persistent insomnia associated with cancer: randomised controlled trial (RCT)

Objective: Does snoring during pregnancy influence development of pre-eclampsia?Method: Five hundred and three pregnant women were presented a questionnaire concerning snoring, daytime sleepiness a ...withdrawn O141 Sleep-wake cycle in ballet dancers M. GLOS, T. PENZEL, J. STRAUCH, C. THEOBALD and I. FIETZE Interdisciplinary Center of Sleep Medicine, Charité-Universitaetsmedizin Berlin, Berlin, Germany and Staatsballett Berlin, Berlin, Germany Introduction: Ballet dancers are top athletes and artists with extreme demands on their body and intellectual functions. In this group a normal work schedule on a weekly basis is absent and moreover, half of the week working days last until late evenings. Methods: We investigated the sleep-wake cycle over a period of three months prior to a premiere of a new performance by using actigraphy in 28 (17w, 11 m) ballet dancers (mean age 27 5 years, BMI 19 2) of the ‘‘Staatsballett Berlin’’, a big independent ballet institution of the three institutionalized opera houses in Berlin, Germany. Before starting the actigraphy recording (Actiwatch, Cambridge Neurotechnology Ltd, Cambridge, UK) which was accompanied by filling in activity diaries and sleep logs on a daily basis, a physical examination as well as a sleep medical examination and ambulatory polygraphy (Embletta PDS, Embla Systems, Broomfield, CO, USA) was performed. Results: Out of the 28 ballet dancers who were included, 24 of them completed the study after three months. Altogether we found a regular sleep-wake cycle but no circaseptan rhythm in this population. In addition a delayed sleep phase was predominant. In the course of three month the sleep efficacy (SE) was reduced significantly (82 to 77 percent, Po0.01) without changes in the amount of movements and total sleep time (TST) during the night. These findings were independent of the gender of the ballet dancers. The parameters SE and TST are generally lower than in the general age matched German population. These results were accompanied by diminished mental health scores (SF12 questionnaire) and diminished concentration capabilities (d2 test). Conclusion: The preparation time of a new performance in the course of three month caused additional stress in the investigated ballet dancers which was apparent in a diminished sleep quality. In order to guarantee a good status of health and the high degree of physical and mental capability a good management of rest and a activity is needed. As a consequence a dedicated room for rest has been installed at the opera for the ballet dancers. r 2008 European Sleep Research Society, JSR 17 (Suppl. 1), 1–271 Spotlight on Circadian Clock Works On and Off Stage 81

Insomnia, mood and fatigue symptoms among newly diagnosed breast cancer patients

Objective: This study investigated group delivery of a mindfulnessbased intervention for primary insomnia in an Australian population. Mindfulness Based Therapy for Insomnia (MBT-I) offers an alternative approach to the current gold standard, non-pharmacological approach to insomnia, CBT-I, with a focus on reducing sleep-related arousal. Findings have indicated reductions in several subjective sleep measures following MBT-I treatment (Ong, Shapiro, & Manber, 2008). This study aimed to investigate the outcome of MBT-I in an Australian population recruited from a sleep clinic to examine the generalizability in a diverse sample. Participants: 30 participants, consisting of 21 females (M age = 50, range = 26–72) and nine males (M age = 45, range 34–59) who met criteria for primary insomnia. Methods: Treatment consisted of six sessions of MBT-I (Ong, Shapiro, & Manber, 2008) delivered in groups of 7–8 with each session lasting 2 h in duration. The primary outcome measure was the Insomnia Severity Index (ISI) and secondary the Pittsburg Sleep Quality Index (PSQI). Outcome measures were recorded at four timepoints (screening, baseline, post-treatment and 3 month follow-up). Results: The average severity of insomnia as measured by the ISI reduced significantly from a moderate level of insomnia (M = 18.74) to sub-clinical insomnia (M = 12.79, P < 0.01) indicating that on average, participants no longer met the criteria for insomnia following treatment. The Pittsburgh Sleep Quality Index (PSQI) overall score reduced significantly (M = 13.1 to M = 9.2, P < 0.01) reflecting an increase in sleep quality following treatment. All 7 PSQI component scores reduced significantly. The largest change was the component score assessing sleep efficiency (the proportion of average sleep compared to time in bed), which increased from 72% to 83% (P < 0.01) following treatment. Conclusion: Analysis of data collected in response to a group treatment of MBT-I for insomnia delivered over 6 weeks revealed significant reductions in insomnia symptoms, and improvements in sleep quality and sleep efficiency. This suggests that MBT-I can be delivered in a sleep clinic setting with indications of effectiveness.