Dataset Information

Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial.

ABSTRACT:

Objective

Perinatal depression (PND) is a severe complication of pregnancy, affecting both mothers and newborns. Bright light therapy (BLT) has only been tested in a few studies for treating either antenatal or postnatal depression. We conducted a pilot trial to investigate the efficacy and safety of BLT for PND occurring at any time across the perinatal period.

Methods

A single-blind RCT was carried out in women with an EPDS >12 from the 2nd gestational trimester until 9 months postpartum. Participants received either 30-minutes morning BLT (10'000 lux) or dim red light (DRL, 19 lux) for 6 weeks.

Results

Twenty-two women were randomised to BLT (n = 11) or DRL (n = 11). Among those receiving BLT, 73% achieved remission (improvement ≥50%, EPDS score ≤ 12), in contrast to 27% in the DRL group (p = 0.04). A significant influence of time on EPDS score and group-time interaction emerged, with a greater reduction in the BLT-group across the follow-up period. No women in either group reported major side effects.

Conclusion

Morning BLT induced a significant remission from PND as compared to DRL and this effect was maintained across the perinatal period. BLT showed an excellent safety profile and was well-tolerated, thus representing a valid therapeutic strategy in this vulnerable perinatal population.

SUBMITTER: Garbazza C

PROVIDER: S-EPMC9804451 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial.

Garbazza Corrado C Cirignotta Fabio F D'Agostino Armando A Cicolin Alessandro A Hackethal Sandra S Wirz-Justice Anna A Cajochen Christian C Manconi Mauro M

Acta psychiatrica Scandinavica 20220803 4

<h4>Objective</h4>Perinatal depression (PND) is a severe complication of pregnancy, affecting both mothers and newborns. Bright light therapy (BLT) has only been tested in a few studies for treating either antenatal or postnatal depression. We conducted a pilot trial to investigate the efficacy and safety of BLT for PND occurring at any time across the perinatal period.<h4>Methods</h4>A single-blind RCT was carried out in women with an EPDS >12 from the 2nd gestational trimester until 9 months p ...[more]

PMID: 35876837

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Project description:ObjectivesApproximately 11%-13% of pregnant women suffer from depression. Bright light therapy (BLT) is a promising treatment, combining direct availability, sufficient efficacy, low costs and high safety for both mother and child. Here, we examined the effects of BLT on depression during pregnancy.DesignRandomised, double-blind controlled trial.SettingPrimary and secondary care in The Netherlands, from November 2016 to March 2019.Participants67 pregnant women (12-32 weeks gestational age) with a DSM-5 diagnosis of depressive disorder (Diagnostic and Statistical Manual of Mental Disorders).InterventionsParticipants were randomly allocated to treatment with either BLT (9000 lux, 5000 K) or dim red light therapy (DRLT, 100 lux, 2700 K), which is considered placebo. For 6 weeks, both groups were treated daily at home for 30 min on awakening. Follow-up took place weekly during the intervention, after 6 weeks of therapy, 3 and 10 weeks after treatment and 2 months postpartum.Primary and secondary outcome measuresDepressive symptoms were measured primarily with the Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder. Secondary measures were the Hamilton Rating Scale for Depression and the Edinburgh Postnatal Depression Scale. Changes in rating scale scores of these questionnaires over time were analysed using generalised linear mixed models.ResultsMedian depression scores decreased by 40.6%-53.1% in the BLT group and by 50.9%-66.7% in the DRLT group. We found no statistically significant difference in symptom change scores between BLT and DRLT. Sensitivity and post-hoc analyses did not change our findings.ConclusionsDepressive symptoms of pregnant women with depression improved in both treatment arms. More research is necessary to determine whether these responses represent true treatment effects, non-specific treatment responses, placebo effects or a combination hereof.Trial registration numberNTR5476.

Project description:BackgroundUp to 70% of nursing home patients with dementia suffer from sleep problems. Light is the main zeitgeber to the circadian system and thus has a fundamental impact on sleep-wake behaviour. Low indoor light levels in nursing homes have been reported, and in combination with age-related reductions in light sensitivity, insufficient light exposure is likely to contribute to sleep problems in this population. Increasing daytime light exposure using bright light treatment (BLT) may represent a feasible non-pharmacological treatment for sleep problems in nursing home patients with dementia.MethodsThe present study reports on sleep outcomes, which are the primary outcomes of the DEM.LIGHT trial (Therapy Light Rooms for Nursing Home Patients with Dementia- Designing Diurnal Conditions for Improved Sleep, Mood and Behavioural Problems), a 24-week cluster-randomised placebo-controlled trial including 8 nursing home units and 69 resident patients. The intervention comprised ambient light of 1000 lx and 6000 K from 10:00 to 15:00, with gradually increasing and decreasing light levels prior to and following this interval, using ceiling mounted light-fixtures and light emitting diode technology. The placebo condition had continuous standard light levels (150-300 lx, ~ 3000 K). Sleep was assessed at baseline and follow-up at week 8, 16, and 24, using the proxy-rated Sleep Disorder Inventory (SDI) and actigraphy (Actiwatch II, Philips Respironics). Mixed linear models were used to evaluate intervention effects, adjusting for relevant covariates such as age, gender, number of drugs, severity of dementia, eye disease, and estimated light exposure.ResultsSleep as measured by the SDI was significantly improved in the intervention group compared to the control group from baseline to week 16 (B = - 0.06, 95% CI -0.11 - -0.01, p < .05) and from baseline to week 24 (B = - 0.05, 95% CI -0.10 - -0.01, p < .05). There was no effect according to the SDI at week 8 and no significant effects in terms of actigraphically measured sleep.ConclusionsProxy-rated sleep improved among nursing home patients with dementia following 16 and 24 weeks of BLT. These improvements were not corroborated by actigraphy recordings.Trial registrationClinicalTrials.gov Identifier: NCT03357328 . Registered 29 November 2017 - Retrospectively registered.

Project description:IntroductionInfliximab (IFX), a monoclonal chimeric antibody against tumour necrosis factor (TNF) α, is effective for induction and maintenance of remission in moderate to severe Crohn's disease. Discontinuation of IFX maintenance therapy in patients in remission should be considered in order to reduce the potential long-term side effects and lower costs.Methods and analysisThis is a prospective, double-blind, randomised, placebo-controlled, multicentre study of patients with luminal Crohn's disease who have been treated with IFX for at least 1 year and are in sustained complete clinical, biochemical and endoscopic remission (ie, Crohn's Disease Activity Index (CDAI) score <150, complete mucosal healing and biochemical markers of inflammation within the normal range). These patients are randomised to receive placebo infusions or continue IFX maintenance therapy. The primary end point is the proportion of patients in maintained remission after 48 weeks (def. CDAI <150).Ethics and disseminationIt is estimated that the knowledge gained about how to optimally handle patients with Crohn's disease in complete long-term sustained remission on IFX is proportionate to the risks and inconveniences related to participation in this study. Prolonged exposure to IFX may cause severe side effects and increased risk of malignancies. Conversely, IFX discontinuation should not unnecessarily create a high risk of relapse. Thus, empirical evidence is needed concerning the safety of discontinuing IFX once a patient exhibits sustained remission. Study results will be published in an English language scientific medical journal. The study is approved by the Danish Medicines Agency (EudraCT-number: 2012-002702-51) and the Regional Ethics Committee of Region Hovedstaden Denmark (Approval-number: H-4-2012-099). The project is reported to the Danish Data Protection Agency (ID-number: 2007-58-0015/HEH.750.89-27), registered at Clinicaltrials.gov, and monitored by independent GCP units for the University of Copenhagen, Odense and Aarhus. The current approved protocol is V.3.2, dated 1 June 2014.Trial registration numberhttp://clinicaltrials.gov/show/NCT01817426.

Project description:ObjectiveTo address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.DesignPilot parallel group randomised controlled feasibility trial.Setting and participantsParticipants aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.InterventionsWe randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).OutcomesRates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.ResultsWe recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.ConclusionsA large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.Trial registration numberISRCTN17544090; Pre-results.

Dataset Information

Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial.

Objective

Methods

Results

Conclusion

Publications

Sustained remission from perinatal depression after bright light therapy: A pilot randomised, placebo-controlled trial.

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