scholarly journals Effectiveness of body-mind-spirit intervention on well-being, functional impairment and quality of life among depressive patients - a randomized controlled trial

2015 ◽  
Vol 71 (9) ◽  
pp. 2153-2163 ◽  
Author(s):  
Sreevani Rentala ◽  
Ted C.T. Fong ◽  
Prasanthi Nattala ◽  
Cecilia L.W. Chan ◽  
Reddemma Konduru
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Functional Impairment ◽  
Controlled Trial ◽  
Well Being ◽  
Randomized Controlled ◽  
Depressive Patients

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

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

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

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

scholarly journals Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial (Preprint)

2020 ◽  
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 (<i>d</i>=1.42, Beck Depression Inventory [BDI-II]; <i>d</i>=0.91, Beck Anxiety Inventory [BAI]; <i>d</i>=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; <i>d</i>=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (<i>d</i>=1.19) and PANAS-N (<i>d</i>=1.28) and medium effect sizes for BAI (<i>d</i>=0.63) and PANAS-P (<i>d</i>=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. CLINICALTRIAL ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758 INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12888-017-1297-z

Effect of physical activity trackers and daily text messages on quality-of-life in colorectal cancer survivors (Smart Pace): a pilot randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Hilary Chan ◽  
Katherine Van Loon ◽  
Stacey A Kenfield ◽  
June Maylin Chan ◽  
Emily Mitchell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Colorectal Cancer ◽  
Randomized Controlled Trial ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Text Messages ◽  
Randomized Controlled

BACKGROUND There are over 1.3 million colorectal cancer (CRC) survivors in the United States, many of whom report lower health-related quality-of-life (HRQoL) for years after diagnosis and treatment. Physical activity may improve survival outcomes and HRQoL for CRC survivors. Feasible interventions to support physical activity after CRC diagnosis are needed. OBJECTIVE This pilot study aimed to explore the impact of digital health intervention on physical activity and HRQoL. METHODS We conducted a two-arm, randomized controlled trial of 41 men and women who had completed treatment for CRC. Participants in the intervention arm were given a Fitbit Flex™ and received daily text messages for 12 weeks. HRQoL was assessed in both arms at enrollment and 12 weeks using the Medical Outcomes Study Short Form Survey (SF-36) and the Functional Assessment of Cancer Treatment – Colorectal (FACT-C). Survey score changes from enrollment to 12 weeks were compared between the two arms using independent t-tests and scores at enrollment and 12 weeks were compared using paired t-tests. RESULTS We observed an increase in the FACT-C functional well-being sub-scale in individuals in the intervention arm pre- to post- intervention (median difference: 2; interquartile range (IQR): 1,4; P = .02). In contrast, no change in functional well-being sub-scale was found in the control arm (median difference: 0; IQR: -1,1; P = .71). No other measures of HRQoL appeared to differ within arm, across time points, or between arms. CONCLUSIONS A 12-week physical activity intervention using a Fitbit Flex™ and daily text messages may improve functional well-being among CRC survivors. Larger randomized studies are needed to definitively determine if a digital physical activity intervention improves functional well-being among CRC survivors and if this improvement can be sustained over time. CLINICALTRIAL ClinicalTrials.gov NCT02966054

Effect of physical activity trackers and daily text messages on quality-of-life in colorectal survivors (Smart Pace): A pilot randomized controlled trial.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 559-559
Author(s):  
Hilary Chan ◽  
Katherine Van Loon ◽  
Stacey A. Kenfield ◽  
June M. Chan ◽  
Emily Mitchell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Physical Activity Intervention ◽  
Controlled Trial ◽  
Well Being ◽  
Text Messages ◽  
Randomized Controlled ◽  
Sf 36

559 Background: There are over 1.3 million colorectal cancer (CRC) survivors in the United States, and many of whom suffer from lower health-related quality-of-life (HRQoL) years after diagnosis and treatment. Physical activity may improve survival outcomes and HRQoL for CRC survivors. Feasible interventions to support physical activity after CRC diagnosis are needed. Methods: We conducted a two-arm randomized controlled trial of 41 men and women who had completed treatment for CRC. Participants in the intervention arm were given a Fitbit Flex™ and received daily text messages for 12 weeks. HRQoL was assessed in both arms at baseline and 12 weeks using the RAND Short Form Survey (SF-36) and the Functional Assessment of Cancer Therapy – Colorectal (FACT-C). Survey score changes from baseline to 12 weeks were compared between the two arms using independent t-tests, and scores at baseline and 12 weeks were compared using paired t-tests. SAS was used for analysis, and statistical significance was declared at p < 0.05. Results: We observed a statistically significant increase in the FACT-C functional well-being sub-scale in individuals in the intervention arm pre- and post- intervention (mean ∆ 1.81 ± 2.76; p: 0.02). There was no change in functional well-being in the control arm (mean ∆ -0.35 ± 4.12; p: 0.71). The between-arm comparison of change from baseline to 12 weeks was not statistically significantly ( p: 0.08). There was a statistically significant increase in the FACT-C emotional well-being sub-scale in the control arm (mean ∆ 1.20 ± 2.48; p: 0.04) and in the SF-36 role physical sub-scale in the control arm (mean ∆ 22.5 ± 38.8; p: 0.02). No other measures of HRQoL were statistically significantly different within groups, across time points, or between groups. Conclusions: A 12-week physical activity intervention using a Fitbit Flex™ and daily text messages may improve functional well-being among CRC survivors. Larger randomized studies are needed to definitively determine if a digital physical activity intervention improves functional well-being among CRC survivors, and if the improvement can be sustained over time. Clinical trial information: NCT02966054.

scholarly journals Monitoring and Discussing Health-Related Quality of Life in Adolescents With Type 1 Diabetes Improve Psychosocial Well-Being: A randomized controlled trial

Diabetes Care ◽  
2008 ◽  
Vol 31 (8) ◽  
pp. 1521-1526 ◽  
Author(s):  
M. de Wit ◽  
H. A. Delemarre-van de Waal ◽  
J. A. Bokma ◽  
K. Haasnoot ◽  
M. C. Houdijk ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Health Related Quality ◽  
Randomized Controlled ◽  
Related Quality ◽  
Health Related
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