Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial).

INTRODUCTION: Insomnia is a prevalent sleep disorder that negatively impacts daytime functioning and quality of life. Breast cancer patients report higher rates of insomnia and more circadian disruption than other cancer groups. Approximately 50% of patients experience acute insomnia following breast cancer diagnosis, which often persists during cancer treatment and rehabilitation. Sleep Restriction Therapy (SRT) is a clinically effective and tolerable treatment for persistent insomnia in breast cancer survivors. However, SRT has never been tested on patients with early signs of sleep disturbance who are undergoing cancer treatment. The aim of this pilot randomised controlled trial is to explore the feasibility and preliminary effectiveness of nurse delivered SRT for newly diagnosed breast cancer patients with acute insomnia. The trial has been registered on ClinicalTrials.gov (identifier: NCT06294041). METHODS: The INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health. DISSEMINATION: Our dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023. STRENGTHS AND LIMITATIONS OF THIS STUDY: This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients.This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness.An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care.Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.

The impact of symptom clusters on endocrine therapy adherence in patients with breast cancer.

BACKGROUND: When taken as prescribed, endocrine therapy is effective in reducing risk of recurrence and mortality in the treatment of patients with breast cancer. However, treatment side effects can act as a barrier to medication adherence. Existing research has not identified any specific side effects as consistent predictors of nonadherence. Our aim was to explore the influence of symptom clusters on self-reported adherence in patients with breast cancer. METHODS: A cross-sectional online survey was conducted, including patients with breast cancer currently or previously prescribed endocrine therapy (N = 1051). This included measures of self-reported endocrine therapy adherence and common symptoms among this population (insomnia, depression, anxiety, fatigue, musculoskeletal, and vasomotor symptoms). RESULTS: Unintentional nonadherence was higher than intentional nonadherence (50.8 % vs 31.01 %). The most troublesome symptom was insomnia (73.83 % displayed probable insomnia disorder). K-means cluster analysis identified 2 symptom clusters: overall High symptoms, and overall Low symptoms. Participants in the Low symptoms cluster were significantly more likely to be classed as adherent based on unintentional and intentional items. CONCLUSIONS: Nonadherence was high in the current sample, and significantly more likely in participants reporting overall severe symptoms. Clinicians should be aware of the scale of common side effects and facilitate open conversation about potential barriers to adherence. Follow-up care should include assessment of common symptoms and signpost patients to appropriate support or treatment when required. Future research should explore potential for a central symptom to act as a target for intervention, to relieve overall side effect burden and facilitate better medication adherence.

Insomnia, depression and anxiety in patients urgently referred with suspicion of head and neck cancer.

OBJECTIVE: To determine differences in insomnia, depression and anxiety between ENT patients with benign and malignant conditions prior to and after an urgent suspicion of cancer appointment. METHODS: Out-patients with urgent suspicion of cancer completed three psychometric questionnaires prior to their appointment and at two to four weeks post-diagnosis. RESULTS: There was no significant difference in questionnaire scores between malignant and benign patients prior to the patients' appointments (p > 0.05 for all questionnaires). In benign patients, there was significant improvement in scores for all questionnaires (p < 0.01) and in malignant patients there was significant worsening of scores for all questionnaires (p < 0.01) at follow-up appointments. CONCLUSION: Prior to appointments, patients with benign and malignant conditions experienced similar levels of insomnia, depression and anxiety. Following diagnosis, cancer patients had significantly poorer scores, indicating worsening of these symptoms. In patients with benign diagnoses, all questionnaire scores improved, indicating resolution of their symptoms and possible association between the appointment and their baseline scores.

Sleep reactivity predicts insomnia in patients diagnosed with breast cancer.

STUDY OBJECTIVES: To examine the role of sleep reactivity as a predictor of insomnia in patients diagnosed with breast cancer. METHODS: A total of 173 women with breast cancer participated and were followed up over a period of 9 months. At baseline, participants were assigned to a high (n = 114) or low (n = 59) sleep reactivity group, based on their responses to the Ford Insomnia Response to Stress Test (FIRST). We assessed whether these FIRST groupings (high/low sleep reactivity) predicted changes in insomnia over time using the Insomnia Severity Index. We also tested if these FIRST groupings predicted insomnia disorder (using Insomnia Severity Index cutoffs) at 3 different time points (T3, T6, and T9). RESULTS: Individuals with high sleep reactivity were more likely to experience a worsening of insomnia. Using logistic regression, we also found that FIRST grouping predicted insomnia disorder. Results remained significant after controlling for estimated premorbid sleep, age, and whether someone had chemotherapy. CONCLUSIONS: Our study shows that sleep reactivity may be a robust predictor of insomnia within breast cancer populations. Sleep reactivity should be considered in routine clinical assessments as a reliable way to identify patients at risk of developing insomnia. This would facilitate early sleep intervention for those patients who are considered high risk. CITATION: Rehman A, Drake CL, Shiramizu V, Fleming L. Sleep reactivity predicts insomnia in patients diagnosed with breast cancer. J Clin Sleep Med. 2022;18(11):2597-2604.

Breast Cancer Survivors' Lived Experience of Adjuvant Hormone Therapy: A Thematic Analysis of Medication Side Effects and Their Impact on Adherence.

Objectives: Side effects from Hormone Therapy (HT) impact medication adherence in breast cancer survivors. Understanding the most distressing HT side effects and their impacts may inform the development and implementation of interventions to alleviate these side effects and maximise HT adherence. This study aimed to explore the lived experience of adjuvant HT and understand the impact of HT side effects on adherence in a sample of breast cancer survivors. Methods: Twenty-five female breast cancer survivors who were currently taking adjuvant HT participated in the study. One-to-one, online, semi-structured interviews were conducted to explore (i) specific side effects from HT and (ii) the impact of these side effects on HT adherence. Data were analysed using Thematic Analysis. Results: The most commonly reported side effects were sleep disturbance, hot flashes, anxiety, and joint pain. Data exploring the impacts of these side effects on HT adherence were thematically synthesised into four analytical themes: "A bitter pill to swallow," "Seeking relief," "Taking control," and "The only way out is through." These themes encompass 14 sub-themes that encapsulate participants' daily struggle with HT side effects and the coping strategies developed to manage these. Conclusion: Adverse side effects from HT, such as sleep disturbance, hot flashes, pain and anxiety, impair quality of life and increase the likelihood of participants' becoming non-adherent to HT medication. In order to maximise HT adherence and reduce breast cancer mortality, HT side effects should be closely monitored to identify individuals who would benefit from targetted intervention strategies aimed at alleviating these side effects.

The impact of medication side effects on adherence and persistence to hormone therapy in breast cancer survivors: A quantitative systematic review.

BACKGROUND: Hormone Therapy (HT) is recommended for most women with HR-positive primary breast cancer. When taken as intended, HT reduces breast cancer recurrence by 40% and mortality by one-third. The recommended duration of treatment ranges from 5 to 10 years depending on risk of recurrence and the specific HT regimen. However, recent data indicates that rates of HT non-adherence are high and research suggests this may be due to the impact of HT side effects. The contribution of side effects to non-adherence and non-persistence behaviours has rarely been systematically explored, thereby hindering the implementation of targeted intervention strategies. Our aim is to identify, evaluate and summarise the relationship between HT side effects and patterns of adherence and persistence. METHODS: Electronic searches were conducted from inception and were completed by September 2021, utilising Cochrane CENTRAL, Medline, Embase, Web of Science and PsycINFO databases. Searches included a combination of terms related to breast cancer, adherence, hormone therapy and side effects. RESULTS: Sixty-two eligible papers were identified and study quality varied by study type. Most observational and cross-sectional studies were rated good quality, whereas most controlled intervention studies were rated fair quality. Three studies were rated poor quality. The most frequently measured side effects were pain, low mood, hot flashes, insomnia, anxiety, fatigue, weight gain, concentration/memory problems. CONCLUSIONS: This review identified a lack of consistency in the measurement of adherence and the definition of persistence across studies. The instruments used to measure side effects also varied significantly. This variation and lack of consistency makes it difficult to evaluate and summarise the role of HT side effects in HT adherence and persistence behaviour.

Sharing positive behavior change made during COVID-19 lockdown: A mixed-methods coproduction study.

OBJECTIVE: The negative consequences of coronavirus disease 2019 (COVID-19) national lockdowns have been well documented, including the worsening of mental health for many and the amplification of preexisting inequalities. As a counterpoint, the current study uses a mixed-methods coproduction approach to share psychosocial insights into the adoption of positive changes made during national lockdown in Scotland. This study examines the psychosocial patterning of positive behavior changes and the psychosocial processes by which positive change was realized and shared these insights with partner organizations. METHOD: A sequential mixed-methods design included an online survey (N = 2,445) assessing positive changes in sleep and physical activity patterns and the role of sociodemographics, mood, social support, coping, and resilience using multivariate logistic regression analysis. Interviews were performed with a purposive diverse subsample of people self-reporting high levels of positive change (n = 48) and used thematic analysis. RESULTS: The survey identified that positive behavior change was significantly patterned by age, gender, and vulnerability to COVID-19. Higher levels of positive reframing and active coping in relation to stress were associated with higher levels of positive behavior change. Higher symptoms of depression, planning, and self-distraction were associated with less positive behavior change. Thematic analysis showed the centrality of perceptions of time, opportunities to self-reflect and engage with the natural world, access support in diverse ways, actively build routine, and purposefully build self-efficacy and a sense of control were key to initiating positive change. CONCLUSIONS: The current study yields insights into achieving positive behavior change at a time of international crisis. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

The impact of medication side effects on adherence and persistence to hormone therapy in breast cancer survivors: A qualitative systematic review and thematic synthesis.

BACKGROUND: Hormone Therapy (HT) reduces the risk of breast cancer recurrence and mortality in women with breast cancer. Despite these clinical benefits, rates of HT non-adherence and non-persistence are high. Research suggests this may be due to the impact of HT side effects. However, little research has explored the individual contribution of side effects to non-adherence and non-persistence behaviours, thereby hindering the implementation of targeted intervention strategies. Our aim is to review the published literature on breast cancer survivors' lived experiences of HT side effects and explore how these may be related to non-adherence and non-persistence behaviour. METHODS: Electronic searches were conducted from inception to May 2020, utilising Cochrane CENTRAL, Medline, Embase, Web of Science and PsycINFO databases. Searches included a combination of terms related to breast cancer, adherence, hormone therapy and side effects. RESULTS: Sixteen eligible papers were identified, and study quality was high. Data were thematically synthesised into four analytical themes, which encompassed 13 descriptive sub-themes: 'Daily impact of side-effects', 'Role of Health Care Professionals', 'Managing HT side-effects', and 'Weighing up the pros and cons'. CONCLUSIONS: HT side effects significantly impact breast cancer survivor's quality of life. A lack of support from healthcare providers leads to self-management strategies, which negatively affects adherence and persistence behaviour.

What have we learned about positive changes experienced during COVID-19 lockdown? Evidence of the social patterning of change.

BACKGROUND: Multiple studies have highlighted the negative impact of COVID-19 and its particular effects on vulnerable sub-populations. Complementing this work, here, we report on the social patterning of self-reported positive changes experienced during COVID-19 national lockdown in Scotland. METHODS: The CATALYST study collected data from 3342 adults in Scotland during weeks 9-12 of a national lockdown. Using a cross-sectional design, participants completed an online questionnaire providing data on key sociodemographic and health variables, and completed a measure of positive change. The positive change measure spanned diverse domains (e.g., more quality time with family, developing new hobbies, more physical activity, and better quality of sleep). We used univariate analysis and stepwise regression to examine the contribution of a range of sociodemographic factors (e.g., age, gender, ethnicity, educational attainment, and employment status) in explaining positive change. RESULTS: There were clear sociodemographic differences across positive change scores. Those reporting higher levels of positive change were female, from younger age groups, married or living with their partner, employed, and in better health. CONCLUSION: Overall our results highlight the social patterning of positive changes during lockdown in Scotland. These findings begin to illuminate the complexity of the unanticipated effects of national lockdown and will be used to support future intervention development work sharing lessons learned from lockdown to increase positive health change amongst those who may benefit.

Adherence to Cognitive Behavior Therapy for Insomnia: An Updated Systematic Review.

This article discusses information extracted from 53 studies that have measured adherence to cognitive behavior therapy for insomnia. There has been an increase in more complex and less biased methods for assessing adherence that move beyond simply asking the patients whether they have adhered to the intervention or not. There is a need for a consensus around how to measure adherence, if clinicians want to arrive at an estimate of optimal adherence. Heterogeneity of studies, particularly in the way adherence is operationalized, prohibited conclusions about the relationship between adherence and outcome, as well as about predictors of adherence.

Living with persistent insomnia after cancer: A qualitative analysis of impact and management.

OBJECTIVES: To conduct a qualitative exploration of the lived experience of insomnia disorder and its management amongst a sample of mixed-diagnoses cancer survivors. METHODS: Twenty-seven cancer survivors with persistent insomnia were recruited to this qualitative study following completion of treatment for breast (12), prostate (7), colorectal (7), and gynaecological (1) cancers. Eleven males and 16 females (mean age 62 years), who met DSM-5 criteria for insomnia disorder, contributed to one of four focus group discussions, designed to explore the lived experience of persistent insomnia and its management within cancer care services. RESULTS: Poor sleep was a persistently troubling complaint for participants, long after the completion of active cancer treatment. The impact of insomnia was significant for all participants, with six key domains emerging as those most affected: temperament, sociability, physical well-being, cognitive functioning, relationships, and psychological well-being. In terms of insomnia management, participants frequently resorted to unfruitful self-management strategies, due to the lack of professional insomnia expertise within cancer care settings. Three main themes emerged in relation to insomnia management: self-management, seeking professional intervention, and a lack of focus on sleep. A lack of clinician understanding of the importance of sleep health and the poor availability of evidence-based insomnia interventions, such as cognitive behavioural therapy for insomnia (CBT-i), were highlighted as important gaps in cancer care. CONCLUSIONS: Insomnia was found to have a detrimental and pervasive impact on cancer survivors' quality of life, which persisted long into survivorship. There is an absence of professional attention to sleep throughout the cancer care trajectory, contributing to its prevalence, persistence, and impact. In order to break this cycle, sleep health should be integrated as a key aspect of cancer treatment and rehabilitation, much like maintaining a healthy diet and appropriate levels of physical activity.

Changes in Physical Activity, Sitting and Sleep across the COVID-19 National Lockdown Period in Scotland.

We examine the impact of the COVID-19 outbreak and concomitant restrictions (i.e., lockdown) on 24-hour movement behaviors (i.e., physical activity, sitting, sleep) in a purposive sample of people (n = 3230) reporting change recruited online. Participants' self-reported time spent in moderate-to-vigorous physical activity (MVPA), walking, sitting and sleep prior to lockdown (T1), during the first national lockdown (T2) and as restrictions initially started to ease (T3). For each 24-hour movement behavior, category-shifts are reported (positive, negative or did not change), as well as the percentage of participants recording positive/negative changes across clusters of behaviors and the percentage of participants recording improvement or maintenance of change across time. From T1 to T2 walking decreased, whereas MVPA, sitting and sleep increased, from T2 to T3 levels returned to pre-lockdown for all but MVPA. Participants who changed one behavior positively were more likely to report a positive change in another and 50% of those who reported positive changes from T1 to T2 maintained or improved further when restrictions started to ease. The current study showed that a large proportion of the sample reported positive changes, most notably those displaying initially poor levels of each behavior. These findings will inform salutogenic intervention development.

The Psychological Predictors of Acute and Chronic Pain in Women Following Breast Cancer Surgery: A Systematic Review.

OBJECTIVES: Numerous psychological factors have been found to be associated with acute and chronic pain following breast cancer surgery. However, individual studies tend to be limited to a small number of predictors and many fail to employ prospective designs. This study aimed to identify a broader range of psychological predictors of acute and chronic pain following breast cancer surgery through a systematic review of relevant prospective studies. METHODS: Web of Science, psychINFO, PubMed, and MEDLINE databases were searched to identify relevant prospective cohort studies. Studies were included if women were to undergo mastectomy or wide local excision, if psychological factors were assessed before surgery, and pain assessed after surgery. RESULTS: Twelve studies (representing 11 independent cohorts) met the inclusion criteria and described 10 psychological predictors. Anxiety and depression were the most frequently assessed psychological factors, and were measured in 9 of the 12 studies. Anxiety and psychological robustness emerged as significant predictors of acute pain. Distress was the strongest predictor of chronic pain. The relationship between depression and chronic postsurgical pain was, at best, mixed. DISCUSSION: This review has identified a range of psychological predictors of acute and chronic pain following breast cancer surgery; however, the evidence was conflicting and limited. Future studies should demonstrate adequate power and take account of known confounders.

Insomnia in breast cancer: a prospective observational study.

STUDY OBJECTIVES: Insomnia in cancer patients is prevalent, persistent, and confers risk for physical and psychological disorder. We must better understand how insomnia develops in cancer patients and explore the main contributors to its chronicity so that insomnia management protocols can be integrated more effectively within cancer care. This study monitors the etiology of insomnia in breast cancer patients and identifies risk factors for its persistence. METHODS: One hundred seventy-three females with newly diagnosed, non-metastatic breast cancer were tracked from diagnosis for 12 months. Participants completed monthly sleep assessments using the Insomnia Severity Index (ISI) and 3 monthly health-related quality-of-life assessments using the European Organisation for Research and Treatment of Cancer - Breast (EORTC QLQ-C30-BR23) scale. Clinical data on disease status and treatment regimens were also assessed. RESULTS: Prior to diagnosis, 25% of participants reported sleep disturbance, including 8% with insomnia syndrome (IS). Prevalence increased at cancer diagnosis to 46% (18% IS) and remained stable thereafter at around 50% (21% IS). We also explored sleep status transitions. The most common pattern was to remain a good sleeper (34%-49%) or to persist with insomnia (23%-46%). Seventy-seven percent of good sleepers developed insomnia during the 12-month period and 54% went into insomnia remission. Chemotherapy (odds ratio = 0.08, 95% confidence interval [CI] 0.02-0.29, p < .001) and pre-diagnosis ISI scores (odds ratio = 1.13/unit increase in pre-diagnosis sleep score, 95% CI 1.05-1.21, p = .001) were identified as the main risk factors for persistent insomnia. CONCLUSIONS: These data advance our understanding of insomnia etiology in cancer patients and help identify those who should be prioritized for insomnia management protocols.

Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies.

Venetoclax is a highly selective, potent BCL-2 inhibitor that is approved for some patients previously treated for chronic lymphocytic leukemia, and has shown promising activity in adult studies across several hematologic malignancies. Preclinical studies have demonstrated venetoclax activity in pediatric patient-derived xenograft models and cell lines; however, clinical studies in pediatric patients have yet to be conducted. The prognosis is poor for children with most relapsed/refractory malignancies, and limited treatment options result in unmet clinical need. Herein, we describe the rationale and design of the first study of venetoclax in pediatric patients with relapsed/refractory malignancies: a Phase I trial investigating the safety and pharmacokinetics of venetoclax monotherapy followed by the addition of chemotherapy (Trial registration: EudraCT 2017-000439-14; NCT03236857).

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

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, Cohen's d=1·11; p<0·0001), paranoia (-2·22, -2·98 to -1·45, Cohen's d=0·19; p<0·0001), and hallucinations (-1·58, -1·98 to -1·18, Cohen's 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.

Attribution, cognition and psychopathology in persistent insomnia disorder: outcome and mediation analysis from a randomized placebo-controlled trial of online cognitive behavioural therapy.

OBJECTIVES: Insomnia patients complain that mental events keep them awake. This study investigates how cognitive behavioural therapy (CBT) affects such events and considers how attributional, cognitive and psychopathological symptoms may mediate sleep improvement. METHOD: A pragmatic, parallel-group randomized controlled trial of 164 adults (120 F: (mean 49 years (18-78 years)) meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder, assigned to CBT (n=55; 40 F), imagery relief therapy (IRT placebo; n=55; 42 F), or treatment as usual (TAU; n=54; 38 F), was conducted. CBT/IRT comprised six online sessions delivered by an animated therapist, with automated web/e-mail support. CBT users had access to a moderated community. TAU comprised 'usual care'. Participants completed the Sleep Disturbance Questionnaire (SDQ), Glasgow Content of Thoughts Inventory (GCTI), Depression Anxiety and Stress Scales (DASS) and Sleep Condition Indicator (SCI) at baseline, post treatment and 8-week follow-up. RESULTS: The sample was characterised by mental arousal, notably 'trying too hard' to sleep (SDQ), and by 'sleep and sleeplessness' and 'rehearsal and planning' thoughts (GCTI). Treatment effects were observed for all SDQ domains (e.g., CBT vs. IRT: d=0.76 for 'trying too hard'). CBT was also superior to IRT on the GCTI (e.g., 'rehearsal and planning', d=0.62; 'sleep and sleeplessness', d=0.74). CBT vs. TAU comparisons yielded larger effects, whereas placebo effects (IRT vs. TAU) were small to moderate. Hierarchical regression demonstrated partial mediation of SCI improvement by attributional and cognitive factors (R2 = 21-27%) following CBT. Improvement in sleep efficiency appears to be independent of such factors. CONCLUSION: Online CBT modifies sleep-related attributions, night-time thought content and psychopathology. This process partly mediates improvement in DSM-5-defined insomnia.

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.

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

OBJECTIVES: 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). METHODS: Baseline data from 113 participants with insomnia were explored to establish rates of and associations between clinical levels of fatigue, anxiety and depression across the sample. Effects of CBT-I on this symptom cluster were also explored by examining changes in pre-treatment to post-treatment levels of fatigue, anxiety and depression. RESULTS: At baseline, the most common symptom presentation was insomnia + fatigue, and 30% of the sample reported at least three co-morbid symptoms. Post-CBT, the number of those experiencing clinical insomnia and clinical fatigue decreased. There were no changes in anxiety rates from baseline to post-treatment in the CBT group and modest reductions in rates of those with clinical depression. Seven individuals (9.6%) from the CBT group were completely symptom free at post-treatment compared with 0% from the treatment as usual condition. Chi-square analysis revealed a significant relationship between group allocation and changes in symptoms of insomnia and fatigue. No such relationship was found between group allocation and mood variables. CONCLUSIONS: These findings confirm the high rate of symptom co-morbidities among cancer patients and highlight strong associations between sleep and fatigue. CBT-I appears to offer generalised benefit to the symptom cluster as a whole and, specifically, is effective in reducing fatigue, which exceeded clinical cut-offs prior to implementation of the intervention. This has implications for the diagnosis/management of common symptoms in cancer patients.