BaSIQS - basic scale on insomnia complaints and quality of sleep: reliability, norms, validity, and accuracy studies, based on clinical and community samples

BackgroundMindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular vesicles (EVs), which are potentially important markers of health, disease, and stress. Moreover, the lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects.MethodsThe current study protocol presents a two-arm, parallel, randomized controlled study investigating the effects of internet-supported mindfulness-based cognitive therapy (MBCT) compared with treatment as usual (TAU). Primary outcomes are psychological distress and EV cargo of distressed participants with previous breast, colorectal, or prostate cancer diagnoses. Secondary outcomes are self-reported psychosocial and health-related measures, and additional biological markers. Outcomes will be assessed at baseline, 4 weeks after baseline (mid-point of the intervention), 8 weeks after baseline (immediately post-intervention), 24 weeks after baseline (after booster sessions), and 52 weeks after baseline. Our goal is to recruit at least 111 participants who have been diagnosed with breast, prostate, or colorectal cancer (cancer stage I to III), are between 18 and 65 years old, and have had primary cancer treatments completed between 3 months and 5 years ago. Half of the participants will be randomized to the TAU group and the other half will participate in an 8-week online MBCT intervention with weekly group sessions via videoconference. The intervention also includes asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions after completion of the 8-week program.DiscussionThis study will allow characterizing the effects of internet-based MBCT on psychosocial and biological indicators in the context of cancer. The effects on circulating EVs will also be investigated, as a possible neurobiological pathway underlying mind-body intervention effects. Trial registration: NCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021; https://clinicaltrials.gov/ct2/show/NCT04727593).

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Section: Social Supportmentioning

confidence: 86%

The Modulatory Role of Internet-Supported Mindfulness-Based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Protocol for A Two-Armed Randomized Controlled Study

Pereira

Silva

Carvalho‐Maia

et al. 2021

Preprint

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“…Normative scores for males and females were presented based on percentiles, 25, 50, and 75. These good psychometric properties were also extended to a Portuguese community sample, and BaSIQS was able to distinguish between people with clinical insomnia and people with sleep disturbance [ 128 ]. In the current study, additional questions available in the plus version of BaSIQS will be included, namely the number of hours usually slept per night during week and weekend, frequency of nights per week wherein the participant is able to sleep the number of needed hours, frequency and duration of naps, and perceived subjective sleep problems.…”

Section: Methodsmentioning

confidence: 99%

The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study

PEREIRA

Silva

Carvalho‐Maia

et al. 2022

Trials

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Background Mindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular vesicles (EVs), which are potentially important markers of health, disease, and stress. Moreover, the lack of RCTs is even more limited within the context of technology-mediated MBIs and long-term effects. Methods The current study protocol presents a two-arm, parallel, randomized controlled study investigating the effects of internet-supported mindfulness-based cognitive therapy (MBCT) compared with treatment as usual (TAU). Primary outcomes are psychological distress and EV cargo of distressed participants with previous breast, colorectal, or prostate cancer diagnoses. Secondary outcomes are self-reported psychosocial and health-related measures, and additional biological markers. Outcomes will be assessed at baseline, 4 weeks after baseline (mid-point of the intervention), 8 weeks after baseline (immediately post-intervention), 24 weeks after baseline (after booster sessions), and 52 weeks after baseline. Our goal is to recruit at least 111 participants who have been diagnosed with breast, prostate, or colorectal cancer (cancer stage I to III), are between 18 and 65 years old, and have had primary cancer treatments completed between 3 months and 5 years ago. Half of the participants will be randomized to the TAU group, and the other half will participate in an 8-week online MBCT intervention with weekly group sessions via videoconference. The intervention also includes asynchronous homework, an online retreat after the fifth week, and 4 monthly booster sessions after completion of the 8-week programme. Discussion This study will allow characterizing the effects of internet-based MBCT on psychosocial and biological indicators in the context of cancer. The effects on circulating EVs will also be investigated, as a possible neurobiological pathway underlying mind-body intervention effects. Trial registration ClinicalTrials.govNCT04727593 (date of registration: 27 January 2021; date of record verification: 6 October 2021).

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“…The mean ( SD , range) duration of insomnia complaints was 13 (11.01, 1–52) years, and 60% of the patients were taking sleeping medication. The Community Sample comprised 1,024 research volunteers (706 women, 318 men), with a mean ( SD , range) age of 34.6 (16.19, 18–95) years, whose data derived from three cross‐sectional studies: 922 young and middle‐aged adults recruited from the general population for a validation study of a Portuguese scale on insomnia and sleep quality, the Basic Scale on Insomnia complaints and Quality of Sleep (BaSIQS) (Miller‐Mendes, Gomes, Ruivo Marques, Clemente, & Azevedo, 2019), 42 adults and older people attending on primary care services for routine examination who participated, as a control group, in research about sleep quality in diabetic patients (Cunha, 2014), and 60 older people from the community, day‐care centres and nursing homes selected for a study on insomnia complaints and morning/evening type (Russo, 2016). They were recruited in different ways depending on the research purpose, using either paper‐and‐pencil or online formats.…”

Section: Methodsmentioning

confidence: 99%

The European Portuguese version of the insomnia severity index

Clemente

Marques

Miller-Mendes

et al. 2020

Journal of Sleep Research

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Summary Insomnia is the most prevalent sleep complaint, but remains largely an unidentified public health issue. The Insomnia Severity Index (ISI) is a brief self‐report questionnaire to assess insomnia, long‐established both in clinical and research settings. The present study aimed to analyse the reliability, validity, and accuracy of the ISI European Portuguese version. After the translation protocol, 1,274 participants (65.54% female), with a mean (SD, range) age of 37.52 (16.82, 18–95) years, completed the ISI. This sample included 250 patients with insomnia from a Sleep Medicine Centre, presenting a diagnosis of insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; International Classification of Sleep Disorders, Third Edition), and 1,024 individuals from the community. A group of 30 patients with obstructive sleep apnea (OSA) was also recruited. Cronbach’s α was 0.88 (internal consistency), and corrected item‐total correlations ranged from 0.56 to 0.83. An exploratory factor analysis (oblique rotation) revealed a two‐factor solution for both clinical and community samples. The ISI total score significantly differentiated insomnia disorder, no insomnia, and OSA subgroups with a large effect size (η 2 = 0.42). The correlation between ISI and Pittsburgh Sleep Quality Index supported concurrent validity (0.82), and discriminant validity was confirmed by a moderate correlation between ISI and Beck Depression Inventory Second Edition (0.32). The area under the curve was 0.88, and the optimal cut‐off to detect clinical insomnia was 14 (82.1% sensitivity, 79.5% specificity). In conclusion, the Portuguese version of the ISI is a reliable and valid measure of insomnia in clinical and non‐clinical populations. Our present study also contributes to relevant data for the international literature regarding the cut‐off score of the scale for the detection of clinical insomnia.

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BaSIQS - basic scale on insomnia complaints and quality of sleep: reliability, norms, validity, and accuracy studies, based on clinical and community samples

Cited by 12 publications

References 27 publications

The Modulatory Role of Internet-Supported Mindfulness-Based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Protocol for A Two-Armed Randomized Controlled Study

The Modulatory Role of Internet-Supported Mindfulness-Based Cognitive Therapy on Extracellular Vesicles and Psychological Distress in People Who Have Had Cancer: A Protocol for A Two-Armed Randomized Controlled Study

The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study

The European Portuguese version of the insomnia severity index

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