Effects of cognitive behavioural therapy and bright light therapy for insomnia in youths with eveningness: study protocol for a randomised controlled trial.

BACKGROUND: Insomnia and eveningness are common and often comorbid conditions in youths. While cognitive behavioural therapy for insomnia (CBT-I) has been suggested as a promising intervention, it remains unclear whether it is sufficient to also address circadian issues in youths. In addition, despite that light has been shown to be effective in phase-shifting one's circadian rhythm, there has been limited data on the effects of bright light therapy and its combination with CBT-I on sleep and circadian outcomes in youths. The current protocol outlines a randomised controlled trial that examines the efficacy of CBT-I and CBT-I plus bright light therapy (BLT) in reducing insomnia severity, improving mood symptoms and daytime functioning (e.g. sleepiness, fatigue, cognitive function), and improving subjective and objective sleep and circadian measures compared to a waitlist control group. METHODS: We will carry out a randomised controlled trial (RCT) with 150 youths aged 12-24 who meet the criteria of insomnia and eveningness. Participants will be randomised into one of three groups: CBT-I with bright light therapy, CBT-I with placebo light, and waitlist control. Six sessions of CBT-I will be delivered in a group format, while participants will be currently asked to use a portable light device for 30 min daily immediately after awakening throughout the intervention period for bright light therapy. The CBT-I with light therapy group will receive bright constant green light (506 lx) while the CBT-I with placebo light group will receive the modified light device with the LEDs emitting less than 10 lx. All participants will be assessed at baseline and post-treatment, while the two active treatment groups will be additionally followed up at 1 month and 6 months post-intervention. The primary outcome will be insomnia severity, as measured by the Insomnia Severity Index. Secondary outcomes include self-reported mood, circadian, daytime functioning, and quality of life measures, as well as sleep parameters derived from actigraphy and sleep diary and neurocognitive assessments. Objective measures of the circadian phase using dim-light melatonin onset assessment and sleep parameters using polysomnography will also be included as the secondary outcomes. DISCUSSION: This study will be the first RCT to directly compare the effects of CBT-I and BLT in youths with insomnia and eveningness. Findings from the study will provide evidence to inform the clinical management of insomnia problems and eveningness in youths. TRIAL REGISTRATION: ClinicalTrials.gov NCT04256915. Registered on 5 February 2020.

Objective and subjective sleep in patients with non-seasonal major depressive disorder and eveningness - Results from a randomized controlled trial of bright light therapy.

STUDY OBJECTIVES: This study examines the (dis)agreement between objective and subjective sleep and their prospective changes in a randomized controlled trial of bright light therapy (BLT) in patients with major depressive disorder (MDD) and eveningness. METHODS: A total of 93 adults were randomized to receive either 30-min daily of 10,000 lux BLT or 50lux placebo dim red light therapy (DRL group) for a total of 5 weeks. Actigraphic data were collected at the baseline and during the last week of treatment. (Dis)Concordance of diary and actigraphic sleep parameters were assessed by partial correlations and Bland-Altman plots, and the associations between these discrepancies to depression severity was assessed by linear regression models. Changes of sleep parameters were assessed by linear mixed models. RESULTS: Significant correlations were found between subjective sleep timings and chronotype to actigraphic parameters. Discrepancies between diary- and actigraphic-measures were observed, and patients with more severe depressive symptoms were associated with a greater under-estimation of total sleep time (TST). A greater advance in the diary-based time to fall sleep and rise time were achieved in the BLT group as compared to the DRL group, while diary-based wake after sleep onset (WASO), TST and sleep efficiency (SE) comparably improved with time in both groups. There was no significant difference between the two groups in the actigraphic parameters after treatment. CONCLUSIONS: In this study, we found that depression severity influenced subjective report of sleep. BLT led to a greater advance in subjective sleep timings when compared to the placebo group.

Prediction of Dropout in a Randomized Controlled Trial of Adjunctive Light Treatment in Patients with Non-Seasonal Depression and Evening Chronotype.

The current study examined the possible predictors of dropout during a five-week light treatment (LT) with a gradual advance protocol in 93 patients with unipolar non-seasonal depression and evening chronotypes by comparing their clinical characteristics and performing a logistic regression analysis. Nineteen out of ninety-three (20%) subjects (80% female, 46.5 ± 11.7 years old) dropped out during the 5-week light treatment. Treatment non-adherence (i.e., receiving LT for less than 80% of the prescribed duration) over the first treatment week predicted a five-fold increase in risk of dropout during light therapy (OR: 5.85, CI: 1.41-24.21) after controlling for potential confounders, including age, gender, treatment group, rise time at the baseline, patient expectation, and treatment-emergent adverse events. There is a need to incorporate strategies to enhance treatment adherence and retention in both research and clinical settings. Chinese clinical trial registry (ChiCTR-IOR-15006937).

Change in circadian preference predicts sustained treatment outcomes in patients with unipolar depression and evening preference.

STUDY OBJECTIVES: Eveningness is associated with worse outcomes in depression. It remained unclear if eveningness could be altered with chronobiological therapy and whether such a change would predict long-term outcomes of depression. METHODS: Data from a randomized controlled trial of 5-week adjunctive bright light therapy with a gradual advance protocol conducted in 91 adult patients with nonseasonal unipolar depression and eveningness (Morningness-Eveningness Questionnaire, score ≤ 41) was examined. "Change of eveningness" was defined by Morningness-Eveningness Questionnaire score over 41 at posttreatment week 5 and "persistent change of eveningness" was defined as maintenance of Morningness-Eveningness Questionnaire score > 41 throughout the follow-up period from week 5 to posttreatment 5 months. RESULTS: Thirty-three participants (36%) had change of eveningness at week 5. Generalized estimating equations models showed that a change of eveningness at week 5 predicted a 2-fold increase in remission of depression over the 5-month follow up (odds ratio = 2.61 95% confidence interval 1.20-5.71, P = .016). Twenty-five participants (75.7%) had a persistent change and were more likely to achieve a remission of depression over the 5-month follow up (odds ratio = 3.18, 95% confidence interval: 1.35-7.50, P = .008). CONCLUSIONS: One-third of the patients with depression changed their evening-preference after 5-week of chronotherapeutic treatment, and such change predicted a higher likelihood of depression remission over 5 months of follow-up. CLINICAL TRIAL REGISTRATION: Registry: Chinese Clinical Trial Registry; Name: Adjunctive light treatment in major depressive disorder patients with evening chronotype-A randomized controlled trial; URL: https://www.chictr.org.cn/showprojen.aspx?proj=11672; Identifier: ChiCTR-IOR-15006937. CITATION: Chan JWY, Chan NY, Li SX, et al. Change in circadian preference predicts sustained treatment outcomes in patients with unipolar depression and evening preference. J Clin Sleep Med. 2022;18(2):523-531.

Non-pharmacological Approaches for Management of Insomnia.

Insomnia is a prevalent sleep problem associated with a constellation of negative health-related outcomes and significant socioeconomic burden. It commonly co-occurs with psychiatric and medical conditions, which may further exacerbate these comorbid conditions and hinder treatment response. There is much empirical evidence to support the clinical efficacy of non-pharmacological treatment for insomnia, especially cognitive behavioral therapy for insomnia (CBT-I), in managing insomnia in a wide range of populations. This article reviews the research on the efficacy of CBT-I for primary insomnia and insomnia comorbid with other psychiatric and medical conditions, the empirical evidence regarding different CBT-I treatment modalities, the implementation of CBT-I across different age groups, and some initial evidence on the sequential combination of insomnia treatments. A brief overview of other non-pharmacological treatment with regard to complementary alternative medicine is also provided.

Help-seeking behaviors for insomnia in Hong Kong Chinese: a community-based study.

OBJECTIVES: To determine the prevalence and correlates of help-seeking behaviors for insomnia in Hong Kong Chinese middle-aged adults and their offspring. METHODS: A total of 2231 middle-aged adults (54.2% females, mean age 45.8 years) and 2186 children and adolescents (51.9% females, mean age 13.4 years) completed a questionnaire on insomnia symptoms, daytime functioning, health condition and treatments sought for insomnia. RESULTS: A total of 40% of adults and 10% of children and adolescents with insomnia reported having sought treatment for insomnia. Conventional Western medicine was the commonly preferred treatment in 33.3% of adults and 13.3% of children and adolescents who sought help for insomnia, while a higher proportion of individuals with insomnia (34.5% of adults and 26.7% of children and adolescents) sought help from complementary and alternative medicine (CAM) therapies. Female gender (odds ratio [OR] [95% confidence interval, CI] = 2.14 [1.01-4.53]), higher family income (≥15,000 HKD/month) (OR [95% CI] = 3.15 [1.27-6.34]), severity of insomnia (Insomnia Severity Index ≥14) (OR [95% CI] = 2.12 [1.10-4.12]), chronic medications (OR [95% CI] = 4.71 [2.27-9.79]), and psychiatric disorders (OR [95% CI] = 2.83 [1.01-7.96]) were associated with help-seeking behaviors in adults. Presence of morning headache was associated with help-seeking behaviors in children and adolescents (OR [95% CI] = 8.66 [1.72-43.70]). CONCLUSIONS: It is uncommon for Hong Kong Chinese to seek help for insomnia, despite the high prevalence of insomnia. The significant unmet need argues for timely intervention to promote sleep-health literacy and to enhance the awareness and accessibility of evidence-based treatment for insomnia.