Digital cognitive behaviour therapy for insomnia in individuals with self-reported insomnia and chronic fatigue: A secondary analysis of a large scale randomized controlled trial

Insomnia is associated with fatigue, but it is unclear whether response to cognitive behaviour therapy for insomnia is altered in individuals with co-occurring symptoms of insomnia and chronic fatigue. This is a secondary analysis using data from 1717 participants with self-reported insomnia in a community-based randomized controlled trial of digital cognitive behaviour therapy for insomnia compared with patient education. We employed baseline ratings of the Chalder Fatigue Questionnaire to identify participants with more or fewer symptoms of self-reported chronic fatigue (chronic fatigue, n = 592; no chronic fatigue, n = 1125). We used linear mixed models with Insomnia Severity Index, Short Form-12 mental health, Short Form-12 physical health, and the Hospital Anxiety and Depression Scale separately as outcome variables. The main covariates were main effects and interactions for time (baseline versus 9-week follow-up), intervention, and chronic fatigue. Participants with chronic fatigue reported significantly greater improvements following digital cognitive behaviour therapy for insomnia compared with patient education on the Insomnia Severity Index (Cohen's d = 1.36, p < 0.001), Short Form-12 mental health (Cohen's d = 0.19, p = 0.029), and Hospital Anxiety and Depression Scale (Cohen's d = 0.18, p = 0.010). There were no significant differences in the effectiveness of digital cognitive behaviour therapy for insomnia between chronic fatigue and no chronic fatigue participants on any outcome. We conclude that in a large community-based sample of adults with insomnia, co-occurring chronic fatigue did not moderate the effectiveness of digital cognitive behaviour therapy for insomnia on any of the tested outcomes. This may further establish digital cognitive behaviour therapy for insomnia as an adjunctive intervention in individuals with physical and mental disorders.publishedVersio

Tumour response in non-small-cell lung cancer patients treated with chemoradiotherapy - Can spectral CT predict recurrence?

INTRODUCTION Tumour response in lung cancer treatment is monitored by measuring lesion size in computed tomography (CT). Spectral CT (SCT) offers additional information on tumour tissue besides morphology. We evaluated SCT iodine content (IC) and performed spectral slope analysis to assess the response of non-small-cell lung cancer (NSCLC) to chemoradiotherapy (CRT). METHODS Eighty-three patients with advanced NSCLC treated by CRT prospectively underwent single-phase, contrast-enhanced SCT. Evaluation of all patients included treatment response (RECIST 1.1), quantitative measurements as well as SCT IC determination and spectral slope analysis in NSCLC primaries. Measurements were performed at the maximum cross-diameter of tumours and in areas with high iodine values (hotspot analysis). Iodine difference (ΔIC) was calculated. Secondary outcome parameters were IC and spectral slopes in mediastinal lymph nodes (n = 61). RESULTS Twenty-four patients (29%) showed complete remission after CRT. Thirty-four patients (41%) had stable disease (SD ) or partial regression (PR ). Progressive disease (PD ) was seen in 25 patients (30%). Hotspot analysis showed significantly higher iodine values in PD than in SD /PR (P < 0.001). Ten patients (12%) with initially stable disease in SCT showed progressive disease during follow-up for up to 18 months (PD ). These patients also had significantly higher hotspot iodine values and ΔIC in the initial scan compared to patients with SD throughout the follow-up period (SD ) (29%) (P < 0.001). Enlarged lymph nodes showed significantly lower iodine content and a lower spectral slope pitch than normal-sized nodes (P = 0.003 to 0.029). CONCLUSION Spectral CT-derived iodine content of NSCLC following CRT may help in predicting recurrence. Hotspot analysis and iodine heterogeneity allow the identification of residual vascularisation as an indicator of vital tumour tissue, indicating that IC might be a suitable imaging biomarker for predicting tumour progression. Iodine content and spectral slope analysis might also help in identifying metastatic lymph nodes

Chronotherapy for patients with a depressive episode treated in a public outpatient mental healthcare clinic in Norway: protocol for a randomised controlled trial

Introduction Depression is highly prevalent in outpatients receiving treatment for mental disorders. Treatment as usual (TAU) usually consists of either psychotherapy and/or antidepressant medication and often takes several weeks before clinical effect. Chronotherapy, consisting of sleep deprivation, sleep-wake phase advancement and stabilisation, and light therapy, is a possible addition to TAU that may decrease the time to treatment response. This randomised controlled trial will examine the benefits of adding chronotherapy to TAU compared with TAU alone.Methods and analysis The trial will include 76 participants with a depressive episode who initiate outpatient treatment at a secondary mental healthcare outpatient clinic at St. Olavs University Hospital. Participants will be randomly allocated 1:1 to either chronotherapy in addition to TAU or TAU alone. Assessments will be performed at baseline, day 3, day 4, day 7, day 14 and weeks 4, 8, 24 and 52, in addition to longer-term follow ups. The main outcome is difference in levels of depressive symptoms after week 1 using the Inventory of Depressive Symptomatology Self-Report. Secondary outcomes include levels of depressive symptoms at other time points, as well as anxiety, health-related quality of life and sleep assessed through subjective and objective measures.Ethics and dissemination The study protocol has been approved by the Regional Committee for Medical Research Ethics Central Norway (ref: 480812) and preregistered at ClinicalTrials.gov (ref: NCT05691647). Results will be published via peer-reviewed publications, presentations at research conferences and presentations for clinicians and other relevant groups. The main outcomes will be provided separately from exploratory analysis.Trial registration number NCT05691647

Rasch analysis of the PANSS negative subscale and exploration of negative symptom trajectories in first-episode schizophrenia – data from the OPTiMiSE trial

The observed heterogeneity in negative symptom treatment response may be partly attributable to inadequate measurement tools or limitations in methods of analysis. Previous Item Response Theory models of the Positive and Negative Syndrome Scale (PANSS) have only examined samples of chronic patients and with mixed results. We examined the scalability of the negative subscale embedded in the PANSS and subsequently explored negative symptom trajectories across four weeks of amisulpride treatment. Data were derived from the OPTiMiSE trial comprising 446 patients with first-episode schizophrenia or schizophreniform disorder. Using the Rasch Model to examine psychometric properties of the PANSS negative subscale, we found that the composite score across items was not an adequate measure of negative symptom severity. Consequently, we chose an exploratory statistical approach involving Principal Component Analysis which yielded one significant component clustering into two significant symptom trajectories: 1) Subtle but constant decrease in negative symptom severity (N = 323; 72%), and 2) symptom instability across visits (N = 19; 4%). Explorative analytic methods as presented here may pave the way for more efficient and sensitive methods of analyzing negative symptom response in research and in clinical practice