Effects of two types of exercise training on psychological well-being, sleep, quality of life and physical fitness in patients with high-grade glioma (WHO III and IV): study protocol for a randomized controlled trial

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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A brief mindfulness based intervention for increase in emotional well-being and quality of life in percutaneous coronary intervention (PCI) patients: the MindfulHeart randomized controlled trial

Journal of Behavioral Medicine ◽

10.1007/s10865-012-9475-4 ◽

2012 ◽

Vol 37 (1) ◽

pp. 135-144 ◽

Cited By ~ 47

Author(s):

Ivan Nyklíček ◽

Suzanne C. Dijksman ◽

Pim J. Lenders ◽

Willem A. Fonteijn ◽

Jacques J. Koolen

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Percutaneous Coronary Intervention ◽

Controlled Trial ◽

Well Being ◽

Coronary Intervention ◽

Randomized Controlled ◽

Percutaneous Coronary

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Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/21335 ◽

2021 ◽

Vol 23 (2) ◽

pp. e21335

Author(s):

Amanda Díaz-García ◽

Alberto González-Robles ◽

Azucena García-Palacios ◽

Javier Fernández-Álvarez ◽

Diana Castilla ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Emotional Disorders ◽

Controlled Trial ◽

Well Being ◽

Effect Sizes ◽

The Internet ◽

Positive And Negative Affect ◽

Randomized Controlled

Background Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. Objective This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. Methods A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. Results Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. Conclusions Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. Trial Registration ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758 International Registered Report Identifier (IRRID) RR2-10.1186/s12888-017-1297-z

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Music to improve sleep quality in adults with depression related insomnia (MUSTAFI): Study protocol for a randomized controlled trial

10.21203/rs.2.10219/v1 ◽

2019 ◽

Author(s):

Helle Nystrup Lund ◽

Inge Nygaard Pedersen ◽

Søren Paaske Johnsen ◽

Agnieszka Maria Heymann-Szlachcinska ◽

Maryla Tuszewska ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Controlled Trial ◽

Pharmacological Intervention ◽

Music Listening ◽

Randomized Controlled ◽

Treatment Of Depression ◽

Experimental Group

Abstract Background Insomnia is a common sleep disorder for adults with depression with major impact on the quality of life. Previous trials suggest that music listening may be helpful in the treatment of sleep disturbances in healthy populations including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented. Objective To examine the efficacy of music listening on sleep quality, symptoms of depression and quality of life in adults with depression related insomnia. Method A single center randomized controlled trial (RCT) in a two arm parallel group design is conducted and reported according to the Consort guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish guidelines in an outpatient unit in psychiatry. The experimental group listen to music minimum 30 minutes at bedtime in four weeks. Discussion This study will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression related insomnia. This study will provide novel knowledge concerning music medicine as an evidence based treatment of depression in psychiatry. Trial Registration: Clinicaltrials.gov. ID NCT03676491, registered on 19th of September 2018.

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Music to improve sleep quality in adults with depression related insomnia (MUSTAFI): Study protocol for a randomized controlled trial

10.21203/rs.2.10219/v3 ◽

2019 ◽

Author(s):

Helle Nystrup Lund ◽

Inge Nygaard Pedersen ◽

Søren Paaske Johnsen ◽

Agnieszka Maria Heymann-Szlachcinska ◽

Maryla Tuszewska ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Controlled Trial ◽

Pharmacological Intervention ◽

Music Listening ◽

Randomized Controlled ◽

Treatment Of Depression ◽

Experimental Group

Abstract Background Insomnia is a common sleep disorder for adults with depression with major impact on the quality of life. Previous trials suggest that music listening may be helpful in the treatment of sleep disturbances in healthy populations including students and elderly. In addition, small studies with clinical populations of traumatized refugees, adults with chronic insomnia and adults with depression insomnia add to the evidence base. However, the impact of music listening in the treatment of depression related insomnia is not well documented. Objective To examine the efficacy of music listening on sleep quality, symptoms of depression and quality of life in adults with depression related insomnia. Method A single center randomized controlled trial (RCT) in a two arm parallel group design is conducted and reported according to the Consort guidelines. The trial consists of an experimental group and a standard care control group. Both groups receive standard treatment for depression following Danish guidelines in an outpatient unit in psychiatry. The experimental group listen to music minimum 30 minutes at bedtime in four weeks. Discussion This study will provide information on the efficacy of music intervention as a non-pharmacological intervention in the treatment of depression related insomnia. This study will provide novel knowledge concerning music medicine as an evidence based treatment of depression in psychiatry. Trial Registration: Clinicaltrials.gov. ID NCT03676491, registered on 19th of September 2018. Keywords: Music, insomnia, depression, sleep

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Walking in pregnancy and prevention of insomnia in third trimester using pedometers: study protocol of Walking_Preg project (WPP). A randomized controlled trial

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03225-y ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

C. Amezcua-Prieto ◽

M. Naveiro-Fuentes ◽

N. Arco-Jiménez ◽

R. Olmedo-Requena ◽

R. Barrios-Rodríguez ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Sleep Quality ◽

Pregnant Women ◽

Controlled Trial ◽

Intervention Group ◽

Third Trimester ◽

Randomized Controlled ◽

In Pregnancy

Abstract Background Previous studies in pregnancy have not focused in evaluating the effect of walking during pregnancy and prevention of insomnia. Our general objective is to determine the effect of a walking program in preventing the appearance of insomnia in the third trimester of pregnancy, increasing sleep quality and improving quality of life throughout pregnancy. Methods Randomized Controlled trial in parallel in healthy sedentary pregnant women (n = 265), Walking_Preg Project (WPP), from university hospital in Granada, Spain. At 12th gestational week (GW), they will be invited to participate and randomly assigned to one of the three arms of study: the intervention group I1 (pedometer, goal of 11,000 steps/day), intervention group I2 (pedometer, no goal) and control (no pedometer). Duration of intervention: 13–32 GW. At 12th, 19th and 31st GW the average steps/day will be measured in groups I1 and I2. At 13th, 20th and 32nd GW, Athens Insomnia Scale (AIS), Pittsburgh Sleep Quality Index (PSQI), Adherence to Mediterranean Diet (AMD), physical activity (short IPAQ), quality of life (PSI), and consumption of toxic substances (caffeine, illegal drugs, alcohol and tobacco) will be collected. Student t test or Mann-Whitney U will be used to compare 19th and 31st GW mean of daily steps between I1 and I2 groups. To compare differences between groups in terms of frequency of insomnia/quality of life for each trimester of pregnancy, Pearson’s Chi-square test or Fisher’s exact test will be used. To determine differences in hours of sleep and quality of sleep throughout each trimester of pregnancy, analysis of variance or Friedman test will be used. McNemar-Bowker test will be used to assess differences in life quality in pre-post analyses in the 3 arms. We will use Stata 15 statistical software. Discussion promoting walking in second half of pregnancy through use of pedometer and health pre-registration of a goal to be achieved –'10,000–11,000 steps a day’– should prevent appearance of insomnia in third trimester, will increase sleep quality and quality of life in pregnant women. Trial registration ClinicalTrials.gov Identifier: NCT03735381. Registered 8th November, 2018.

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