scholarly journals Triple chronotherapy for the rapid treatment and maintenance of response in depressed outpatients: a feasibility and pilot randomised controlled trial

BJPsych Open ◽  
2021 ◽  
Vol 7 (S1) ◽  
pp. S58-S58
Author(s):  
David Veale ◽  
Marc Serfaty ◽  
Clara Humpston ◽  
Andriani Papageorgiou ◽  
Sarah Markham ◽  
...  
Keyword(s):  
Sleep Deprivation ◽  
Rating Scale ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Bright Light ◽  
Light Therapy ◽  
Phase Advance ◽  
Control Group ◽  
Significant Difference ◽  
Rapid Treatment

AimsTriple chronotherapy (defined as sleep deprivation for 36 hours, followed by 4 days of advancing the time of sleep, together with daily morning bright light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in 4 small, controlled trials of in-patients. Our aims were to test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression.MethodIn a single blind trial, 82 participants were randomised to either triple chronotherapy or a control intervention. The primary outcome was Hamilton Depression Rating Scale 6 item (HAM-D6) at 1 week. Timings of observer ratings were baseline; 1 week; 2 weeks; 4 weeks; 8 weeks and 26 weeks after randomisation. Triple chronotherapy consisted of (a) Total sleep deprivation for 36 hours. On Day 1 patients were supported in a small group to stay awake at night with an occupational therapist, (b) Phase Advance of Sleep over 4 days. Phase Advance began after the first night of sleep deprivation, when they left the hospital at about 8am and were asked to go to bed earlier at about 5pm and rise at about 1am. Their sleep and wake up times were then shifted 2 hours later on each of the following three days until they attained their usual bedtime again at about 11pm.As a control for the triple chronotherapy, participants were given psychoeducation and written information on sleep hygiene. They were also given SomniLight amber light daily for 1 week in the morning.ResultParticipants in the triple chronotherapy group were able to stay awake for the planned thirty-six hours and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target with 60 participants having completed the trial within 13 months. There were no reported adverse side effects. We explored outcomes and found a significant difference between the groups for the HAM-D6 at week 1, 8 and 26. Response (> 50% reduction in symptoms) was achieved by 52% in the triple chronotherapy group compared to 18% in the control group at week 1. This gradually increased to 70% achieving response in the triple chronotherapy group at week 26 compared to 22% in the control group.ConclusionTriple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Further cost-effective trials with a larger clinical sample size are required.

scholarly journals Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression: feasibility and pilot randomised controlled trial

BJPsych Open ◽  
2021 ◽  
Vol 7 (6) ◽  
Author(s):  
David Veale ◽  
Marc Serfaty ◽  
Clara Humpston ◽  
Andriani Papageorgiou ◽  
Sarah Markham ◽  
...  
Keyword(s):  
Rating Scale ◽  
Clinical Sample ◽  
Controlled Trial ◽  
Bright Light ◽  
Light Therapy ◽  
Control Group ◽  
Intention To Treat ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Rapid Treatment

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required.

scholarly journals Effects of bright light therapy for depression during pregnancy: a randomised, double-blind controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038030
Author(s):  
Babette Bais ◽  
Astrid M Kamperman ◽  
Hilmar H Bijma ◽  
Witte JG Hoogendijk ◽  
Jan L Souman ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Pregnant Women ◽  
Rating Scale ◽  
Controlled Trial ◽  
Depression Scale ◽  
Bright Light ◽  
Light Therapy ◽  
Secondary Outcome ◽  
Bright Light Therapy ◽  
Double Blind

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.

scholarly journals Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

2016 ◽  
Vol 9 (5) ◽  
pp. 67
Author(s):  
Mansoureh Mirzadeh ◽  
Najmeh Shahini ◽  
Masoud Kashani Lotf Abadi ◽  
Maryam Tavakoli ◽  
Arash Javanbakht ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Function ◽  
Rating Scale ◽  
Controlled Trial ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Schizophrenic Patients

<p>Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients.<strong> </strong>This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14<sup>th</sup> and 28<sup>th</sup> days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2<sup>nd</sup>, 7<sup>th</sup>, 14<sup>th</sup>, 28<sup>th</sup>. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28<sup>th</sup> compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor<strong> </strong><strong>p </strong>value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05.<strong> </strong>Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.</p>

scholarly journals Effectiveness of a Snoezelen Room on Fear, Anxiety, and Satisfaction of Nulliparous Women: A Randomized Controlled Trial

2020 ◽  
Vol 14 (2) ◽  
Author(s):  
Mariyam Momeni ◽  
Mansoureh Jamshidimanesh ◽  
Hadi Ranjbar
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Control Group ◽  
Chi Square ◽  
Nulliparous Women ◽  
Significant Difference ◽  
Interventional Group

Background: Pregnancy and childbirth are natural phenomena in a women’s life, associated with stress and anxiety, leading to adverse effects in the mother and fetus. Using complementary medicine, such as aromatherapy, music, light radiation, and aquariums in an environment that engage a person’s multiple senses can make mothers relax through mental deviations. Objectives: The aim of this study was to evaluate the effects of a Snoezelen room on fear, anxiety, and satisfaction of childbirth’s nulliparous women. Methods: This randomized clinical trial was carried out on 130 eligible women in a selected hospital affiliated to the Iran University of Medical Sciences in Tehran. One hundred thirty women were randomly assigned to the intervention (n = 65) and control (n = 65) groups using six modes blocks using the convenient sampling method. The delivery room was designed to distract women’s minds in the intervention group. Data were collected using a demographic characteristics form, Harman’s Childbirth Attitude questionnaire (CAQ), Visual Analogue scale (VAS) to measure childbirth anxiety, and the Mackey Childbirth Satisfaction Rating scale. Data were analyzed by SPSS version 16 using independent t-test, repeated measures analysis of variance, and Bonferroni and chi-square tests. Results: The results showed a significant reduction in fear in the active phase and postpartum in the intervention group compared with the control group (P < 0.001 and P < 0.001, respectively). Anxiety showed a significant difference and was lower at dilatation of 6 to 7 and 7 to 8 cm, and after childbirth in the interventional group. The satisfaction of childbirth significantly increased in the interventional group (P < 0.001). Conclusions: These results confirmed the importance of a Snoezelen room in the childbirth of nulliparous women, which can promote vaginal childbirth.

Total sleep deprivation followed by sleep phase advance and bright light therapy in drug-resistant mood disorders

2013 ◽  
Vol 144 (1-2) ◽  
pp. 28-33 ◽  
Author(s):  
Masaru Echizenya ◽  
Hideka Suda ◽  
Masahiro Takeshima ◽  
Yoshiyuki Inomata ◽  
Tetsuo Shimizu
Keyword(s):  
Sleep Deprivation ◽  
Mood Disorders ◽  
Bright Light ◽  
Light Therapy ◽  
Phase Advance ◽  
Drug Resistant ◽  
Bright Light Therapy ◽  
Sleep Phase ◽  
Total Sleep Deprivation

scholarly journals Clinical Study on the Prevention of Oxaliplatin-Induced Neurotoxicity with Guilongtongluofang: Results of a Randomized, Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Yunfang Liu ◽  
Guangying Zhu ◽  
Li Han ◽  
Jie Liu ◽  
Ting Ma ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Rating Scale ◽  
Tumor Response ◽  
Controlled Trial ◽  
Control Group ◽  
Trial Group ◽  
Peripheral Neurotoxicity ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

Objective. Oxaliplatin-induced peripheral neurotoxicity continues to be a kind of frequent dose-limiting toxicity for many cancer patients. This study evaluated the preventive effects of Guilongtongluofang on peripheral neurotoxicity induced by oxaliplatin in patients with colorectal tumor.Patients and Methods. From May 2007 to May 2011, we conducted a randomized, double-blind, placebo-controlled trial. 120 patients of colorectal cancer treated with adjuvant oxaliplatin-based chemotherapy were randomly enrolled into the trial group and the control group. The trial group received Guilongtongluofang (at a dose of 200 mL once a day) from 3 days prior to chemotherapy. The control group received a placebo from 3 days prior to chemotherapy. Every 2-week cycle, neurotoxicity was evaluated using numeric rating scale for pain intensity and experienced relief. The primary endpoint was efficacy measurement which included oxaliplatin-induced neurotoxicity and tumor response. The differences of side effects between the two groups were also analyzed.Results. The percentage of grades 1-2 neurotoxicity was significantly lower in the trial group than that in the control group (13.3% versus 20.0%;P<0.05) after two cycles of treatment. The difference of the percentage of neurotoxicity between the two groups was significant after six cycles (51.7% versus 70.0%;P<0.05). Significant difference for the mean time to the development of grade 1+ neurotoxicity was found between the two groups (9.4 w in the trial group versus 6.5 w in the control group,P<0.05). The cumulative incidence of grade 1 or more sensory neurotoxicity was significantly lower in the trial group than that in the control group (P<0.05). No significant differences of tumor response rate were found between the two groups the trial group and the control group. No significant difference was found between the trial group and the control group (allP>0.05).Conclusion. This study provides evidence that Guilongtongluofang is a promising drug for the prevention of oxaliplatin-induced neurotoxicity in patients with colorectal cancer, and it does not reduce the efficacy of oxaliplatin.

scholarly journals Celecoxib added to mood stabilizer for treating acute mania in bipolar disorder: A randomized, double -blind, placebo-controlled trial in IRAN

2021 ◽  
Author(s):  
Farhad Faridhosseini ◽  
Ali Talaei ◽  
Najmeh Shahini ◽  
Mahbobeh Eslamzadeh ◽  
Samira Ahrari ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Acute Mania ◽  
Control Group ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Valproate Sodium ◽  
Significant Difference

Abstract Background: Inflammatory processes in the brain contribute to the aetiopathogenesis of acute mania. Cyclooxygenase-2 (COX-2) inhibitors, such as Celecoxib, reduce the production of pro-inflammatory cytokines. The purpose of the present investigation was to assess the efficacy of Celecoxib in the treatment of acute mania.Methods: We conducted a double-blind, placebo-controlled trial at the Specialty in-patient Clinic of Ibn-e-Sina Hospital [Mashhad University of Medical Sciences, Iran] from March 2017 to August 2017. The study involved 58 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for acute mania screening to participate in the trial were used for the study. Twenty-three patients were assigned to a study group and were given Valproate Sodium 200 mg /BD plus Celecoxib 400 mg/day (200 mg BID). The control group included 22 patients who were given Valproate Sodium 200 mg /BD plus placebo. Patients were assessed by Young Mania Rating Scale (YMRS) at baseline 0, after 9, 18, and 28 days after the medication started. Data were analyzed by using Statistical Package for Social Sciences (SPSS) 11.5., two-way repeated measures analysis of variance, Fisher’s exact test, and T-Test. P≤0.05 was considered to be statistically significant.Results: A total of 58 patients were screened and 45 were randomized. Most of participations in celecoxib group were male (55%) and in placebo group were female (75%). There were no statistically significant differences between the groups regarding number of episode. sex, marital status, past medical history, past psychiatry history and family history P value ≥0.05. A significant difference was observed in the change of scores on Young Mania Rating Scale (YMRS) at week 4 as compared to the baseline in patient groups P: 0.04.Conclusion: This study suggested that Celecoxib can be an effective adjuvant agent in managing patients with acute mania and anti-inflammatory therapies should further be investigated in these patients.Trial registration: Iran clinical trial register: IRCT20200306046708N1

scholarly journals Treatment of back pain in active axial spondyloarthritis with serial locoregional water-filtered infrared A radiation: A randomized controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Philipp Klemm ◽  
Iris Aykara ◽  
Markus Eichelmann ◽  
Elena Neumann ◽  
Klaus Frommer ◽  
...  
Keyword(s):  
Back Pain ◽  
Rating Scale ◽  
Axial Spondyloarthritis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Serum Cytokine ◽  
Significant Difference ◽  
Cytokine Levels

BACKGROUND: Axial spondyloarthritis (axSpA) is an inflammatory rheumatic disease primarily affecting the axial skeleton. OBJECTIVE: To evaluate the short-term effects of locoregional water-filtered infrared A radiation (sl-wIRAR) in the treatment of lower back pain in patients with axSpA. METHODS: Patients with active axSpA with non-steroidal anti-inflammatory drug (NSAID) therapy undergoing a 7-day multimodal rheumatologic complex treatment in an in-patient setting were eligible. Patients were randomly assigned to the intervention group (IG) receiving sl-wIRAR treatment of the back (2 treatments/day for 30 min each for 6 days) or to the control group (CG) receiving no treatment. Primary outcome was a between-group difference in pain after sl-wIRAR therapy measured on a numeric rating scale (NRS) (0 = no pain, 10 = worst pain). Secondary outcomes included an assessment of i) the onset and development of analgesic effects and an evaluation of whether sl-wIRAR ii) improved axSpA-specific well-being and iii) influenced serum cytokine levels. RESULTS: Seventy-one patients were enrolled, completed the trial and were analyzed (IG: 36 patients, CG: 35 patients). In the IG, there was a statistically significant change (p< 0.0005) in pain level [NRS] (1.6 ± 1.9 [5; 2]) from baseline (4.1 ± 2.4 [0; 8]) to trial completion (2.6 ± 2.0 [0; 7]) and a significant difference to the CG (p= 0.006). In the IG there was a significant improvement in axSpA-specific well-being (BAS-G) (p= 0.006). A physiologically relevant change in serum cytokine levels could not be observed. CONCLUSION: sl-wIRAR treatment can be useful in the treatment of patients with active axSpA as it leads to a rapid reduction of pain.

Reducing the Social Stigma Associated with Obsessive Compulsive Disorder: A Controlled Trial of an Intervention Program in a Turkish Community Sample

2020 ◽  
Vol 20 (2) ◽  
pp. 101-120
Author(s):  
Ayça Aktaç Gürbüz ◽  
Orçun YORULMAZ ◽  
Gülşah DURNA
Keyword(s):  
Obsessive Compulsive Disorder ◽  
Intervention Program ◽  
Controlled Trial ◽  
Community Sample ◽  
Case Vignette ◽  
Control Group ◽  
Obsessive Compulsive ◽  
Compulsive Disorder ◽  
Significant Difference ◽  
The Impact

Scientific research into the reduction of stigmatization, particularly related to specific problems such as Obsessive-Compulsive Disorder (OCD), is scarce. In the present study, we examine the impact of a video-based antistigma intervention program for OCD in a pretest-posttest control group research. After being randomly assigned to either an intervention (n= 101) or control group (n= 96), the participants reported their attitudes on a hypothetical case vignette before and after OCD vs. Multiple Sclerosis (MS) videos, and again six months later as a follow up assessment. The mixed design analyses for the group comparisons indicated that although there was no significant difference in the measures of the control group, the participants watching the anti-stigma OCD video, in which the focus was psychoeducation and interaction strategies, reported significantly lower scores on social distances and negative beliefs for the case vignettes they read, and this difference was maintained six months later. Then, the present results indicate the effectiveness of our anti-stigma intervention program for OCD. Interventions to reduce stigmatization can also be viewed as effective tools for changing the attitudes of people toward OCD, although further research and applications are needed related to specific disorders if a longlasting impact is to be achieved.

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