Treating postpartum insomnia: a three arm randomised controlled trial of cognitive behavioural therapy and light dark therapy.

BACKGROUND: Insomnia symptoms are common during the postpartum period, yet interventions remain scarce. This trial aimed to simultaneously examine the efficacy of cognitive behavioural therapy (CBT) and light dark therapy (LDT), targeting different mechanisms, against treatment-as-usual (TAU), in reducing maternal postpartum insomnia symptoms. METHODS: This three-arm randomised controlled trial recruited from the general community in Australia. Nulliparous females 4-12 months postpartum with self-reported insomnia symptoms [Insomnia Severity Index (ISI) scores >7] were included; severe medical/psychiatric conditions were excluded. Participants were randomised 1:1:1 to CBT, LDT, or TAU stratified by ISI (< or ⩾14) and infant age (< or ⩾8 months). Participants and principal investigators were unblinded. Six-week interventions were delivered via digital materials and telephone. The primary outcome was insomnia symptoms (ISI), assessed pre-, midpoint-, post- (primary endpoint), and one-month post-intervention. Analyses were intention-to-treat using latent growth models. RESULTS: 114 participants (CBT = 39, LDT = 36, TAU = 39; Mage = 32.20 ± 4.62 years) were randomised. There were significantly greater reductions in ISI scores in CBT and LDT (effect sizes -2.01 and -1.52 respectively, p < 0.001) from baseline to post-intervention compared to TAU; improvements were maintained at follow-up. Similar effects were observed for self-reported sleep disturbance. There were greater reductions in fatigue in CBT (effect size = 0.85, p < 0.001) but not LDT (p = 0.11) compared to TAU. Changes in sleepiness, depression, and anxiety were non-significant compared to TAU (all p > 0.08). Four participants (11%) in the LDT group reported headaches, dizziness, or nausea; no others reported adverse events. CONCLUSIONS: Therapist-assisted CBT and LDT were feasible during the first postpartum year; data at post-intervention and 1-month follow-up support their safety and efficacy in reducing postpartum insomnia symptoms.

[Chronotherapy of affective disorders: principles and clinical aspects]. / Chronotherapie affektiver Störungen: Grundlagen und klinische Aspekte.

BACKGROUND: Chronobiological processes play a critical role in the initial manifestation and course of affective disorders. Chronotherapeutic agents aim to improve sleep-wake cycle disturbances and affective symptoms by modulating the chronobiological neuronal circuitry. OBJECTIVE: To review the different chronotherapeutic procedures, the current evidence situation and recommendations for clinical applications. METHOD: Narrative review. RESULTS: Chronotherapeutic interventions for patients with affective disorders can be nonpharmacological, e.g., light therapy, sleep deprivation, sleep phase advance and dark therapy, pharmacological in the form of melatonin and psychological consisting of interpersonal and social rhythm therapy or cognitive behavioral therapy for insomnia modified for patients with bipolar disorder. Nearly all these interventions show promising data regarding their efficacy in acute depressive or manic episodes or as maintenance therapy. For melatonin, there is less evidence for improvement of affective symptoms than for stabilizing the sleep-wake cycle. Some interventions are well-suited for an outpatient setting, e.g., light therapy, dark therapy and psychotherapy, while others, such as triple chronotherapy consisting of sleep deprivation, sleep phase advance and light therapy, are more suited for in-patient treatment. CONCLUSION: Chronotherapeutic interventions are versatile in their application and can be combined with each other and used concomitantly with classical psychopharmacotherapy. With a benign side effect profile and good evidence for efficacy, they could play an important role in the treatment of affective disorders; however, this potential is used too rarely in the clinical context.

The chronotherapeutic treatment of bipolar disorders: A systematic review and practice recommendations from the ISBD task force on chronotherapy and chronobiology.

AIMS: To systematically review the literature on the efficacy and tolerability of the major chronotherapeutic treatments of bipolar disorders (BD)-bright light therapy (LT), dark therapy (DT), treatments utilizing sleep deprivation (SD), melatonergic agonists (MA), interpersonal social rhythm therapy (IPSRT), and cognitive behavioral therapy adapted for BD (CBTI-BP)-and propose treatment recommendations based on a synthesis of the evidence. METHODS: PRISMA-based systematic review of the literature. RESULTS: The acute antidepressant (AD) efficacy of LT was supported by several open-label studies, three randomized controlled trials (RCTs), and one pseudorandomized controlled trial. SD showed rapid, acute AD response rates of 43.9%, 59.3%, and 59.4% in eight case series, 11 uncontrolled, studies, and one RCT, respectively. Adjunctive DT obtained significant, rapid anti-manic results in one RCT and one controlled study. The seven studies on MA yielded very limited data on acute antidepressant activity, conflicting evidence of both antimanic and maintenance efficacy, and support from two case series of improved sleep in both acute and euthymic states. IPSRT monotherapy for bipolar II depression had acute response rates of 41%, 67%, and 67.4% in two open studies and one RCT, respectively; as adjunctive therapy for bipolar depression in one RCT, and efficacy in reducing relapse in two RCTs. Among euthymic BD subjects with insomnia, a single RCT found CBTI-BP effective in delaying manic relapse and improving sleep. Chronotherapies were generally safe and well-tolerated. CONCLUSIONS: The outcome literature on the adjunctive use of chronotherapeutic treatments for BP is variable, with evidence bases that differ in size, study quality, level of evidence, and non-standardized treatment protocols. Evidence-informed practice recommendations are offered.

Blue-blocking glasses as additive treatment for mania: a randomized placebo-controlled trial.

OBJECTIVES: The discovery of the blue lightsensitive retinal photoreceptor responsible for signaling daytime to the brain suggested that light to the circadian system could be inhibited by using blue-blocking orange tinted glasses. Blue-blocking (BB) glasses are a potential treatment option for bipolar mania. We examined the effectiveness of BB glasses in hospitalized patients with bipolar disorder in a manic state. METHODS: In a single-blinded, randomized, placebo-controlled trial (RCT), eligible patients (with bipolar mania; age 18-70 years) were recruited from five clinics in Norway. Patients were assigned to BB glasses or placebo (clear glasses) from 6 p.m. to 8 a.m. for 7 days, in addition to treatment as usual. Symptoms were assessed daily by use of the Young Mania Rating Scale (YMRS). Motor activity was assessed by actigraphy, and compared to data from a healthy control group. Wearing glasses for one evening/night qualified for inclusion in the intention-to-treat analysis. RESULTS: From February 2012 to February 2015, 32 patients were enrolled. Eight patients dropped out and one was excluded, resulting in 12 patients in the BB group and 11 patients in the placebo group. The mean decline in YMRS score was 14.1 [95% confidence interval (CI): 9.7-18.5] in the BB group, and 1.7 (95% CI: -4.0 to 7.4) in the placebo group, yielding an effect size of 1.86 (Cohen's d). In the BB group, one patient reported headache and two patients experienced easily reversible depressive symptoms. CONCLUSIONS: This RCT shows that BB glasses are effective and feasible as add-on treatment for bipolar mania.

Chronobiological Therapy for Mood Disorders.

Chronobiological therapies for mood disorders include manipulations of the sleep-wake cycle such as sleep deprivation and sleep phase advance and the controlled exposure to light and darkness. Their antidepressant efficacy can overcome drug resistance and targets the core depressive symptoms including suicide, thus making them treatment options to be tried either alone or as adjunctive treatments combined with common psychopharmacological interventions. The specific pattern of mood change observed with chronobiological therapies is characterized by rapid and sustained effects, when used among themselves or combined with drugs. Effects sizes are the same reported for the most effective psychiatric treatments, but side effects are usually marginal or absent. New treatment protocols are developed to adapt them in different clinical settings. This review deals with the general principles of clinical chronobiology and the latest findings in this rapidly developing field.

BLUES - stabilizing mood and sleep with blue blocking eyewear in bipolar disorder - a randomized controlled trial study protocol.

INTRODUCTION: Chronotherapeutic interventions for bipolar depression and mania are promising interventions associated with rapid response and benign side effect profiles. Filtering of biologically active short wavelength (blue) light by orange tinted eyewear has been shown to induce antimanic and sleep promoting effects in inpatient mania. We here describe a study protocol assessing acute and long-term stabilizing effects of blue blocking (BB) glasses in outpatient treatment of bipolar disorder. PATIENTS AND METHODS: A total of 150 outpatients with bipolar disorder and current symptoms of (hypo)-mania will be randomized 1:1 to wear glasses with either high (99%) (intervention group) or low (15%) (control group) filtration of short wavelength light (<500 nm). Following a baseline assessment including ratings of manic and depressive symptoms, sleep questionnaires, pupillometric evaluation and 48-h actigraphy, participants will wear the glasses from 6 PM to 8 AM for 7 consecutive days. The primary outcome is the between group difference in change in Young Mania Rating Scale scores after 7 days of intervention (day 9). Following the initial treatment period, the long-term stabilizing effects on mood and sleep will be explored in a 3-month treatment paradigm, where the period of BB treatment is tailored to the current symptomatology using a 14-h antimanic schedule during (hypo-) manic episodes (BB glasses or dark bedroom from 6 PM to 8 AM) and a 2-h maintenance schedule (BB glasses on two hours prior to bedtime/dark bedroom) during euthymic and depressive states.The assessments will be repeated at follow-up visits after 1 and 3 months. Throughout the 3-month study period, participants will perform continuous daily self-monitoring of mood, sleep and activity in a smartphone-based app. Secondary outcomes include between-group differences in actigraphic sleep parameters on day 9 and in day-to-day instability in mood, sleep and activity, general functioning and objective sleep markers (actigraphy) at weeks 5 and 15. TRIAL REGISTRATION: The trial will be registered at www.clinicaltrials.gov prior to initiation and has not yet received a trial reference. ADMINISTRATIVE INFORMATION: The current paper is based on protocol version 1.0_31.07.23. Trial sponsor: Lars Vedel Kessing.

Adherence and acceptability of light therapies to improve sleep in intrinsic circadian rhythm sleep disorders and neuropsychiatric illness: a systematic review.

Sleep problems and circadian misalignment affect health and well-being and are highly prevalent in those with co-morbid neuropsychiatric disorders. Interventions altering light exposure patterns of affected individuals are a promising non-pharmacological treatment option, shown by previous meta-analyses to improve sleep, and often described as minimally invasive. To best translate laboratory-based mechanistic research into effective treatments, acceptability and barriers to adherence should be understood, but these have not yet been systematically evaluated. Here, we examined evidence regarding adherence and acceptability in studies of light or dark interventions using various delivery devices and protocols to improve sleep in intrinsic circadian rhythm sleep-wake disorders and neuropsychiatric illness. Attrition during intervention was low, and reported experiences were largely positive, but measurement and reporting of self-reported experiences, expectations, and adverse effects were poor. Approaches to management and measurement of adherence were varied, and available light monitoring technology appeared under-exploited, as did mobile technology to prompt or track adherence. Based on these findings we suggest recommended reporting items on acceptability and adherence for future investigations. Few studies assessed baseline light exposure patterns, and few personalised interventions. Overall, many applied studies exhibited an approach to light schedule interventions still reminiscent of laboratory protocols; this is unlikely to maximise acceptability and clinical effectiveness. For the next phase of translational research, user acceptability and adherence should receive increased attention during intervention design and study design. We suggest framing light therapies as complex interventions, and emphasise the occupationally embedded (daily activity routine embedded) context in which they occur.