The Validation of a Provider-Reported Fidelity Measure for the Transdiagnostic Sleep and Circadian Intervention in a Community Mental Health Setting.
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SUBMITTER: Gumport NB
PROVIDER: S-EPMC7431680 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Severe mental illness (SMI) is common, chronic and difficult to treat. Sleep and circadian dysfunctions are prominent correlates of SMI, yet have been minimally studied in ways that reflect the complexity of the sleep problems experienced. Prior treatment studies have been disorder-focused-they have treated a specific sleep problem in a specific diagnostic group. However, real life sleep and circadianproblems are not so neatly categorized, particularly in SMI where features of insomnia overlap with hypersomnia, delayed sleep phase and irregular sleep-wake schedules. Accordingly, the aim of this studyprotocol is to test the hypothesis that a Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) will improve functional impairment, disorder-focused symptoms and sleep and circadian functioning. Participants across DSM diagnoses and across common sleep and circadian problems are eligible. The elements of TranS-C are efficacious across SMI in research settings with research-based providers. The next step is to test TranS-C in a community setting. Accordingly, this study is being conducted within Alameda County Behavioral Health Care Services (ACBHCS), the Community Mental Health Centre (CMHC) for Alameda County.120 adults diagnosed with SMI and sleep and circadian dysfunction within ACBHCS will be randomly allocated to TranS-C (n = 60) or 6-months of Usual Care followed by Delayed Treatment with TranS-C (UC-DT; n = 60). TranS-C is modularized and delivered across eight to twelve 50-minute, weekly, individual sessions. All participants will be assessed before and immediately following treatment and again 6 months later. Primary analysis will examine whether TranS-C significantly improves functional impairment, disorder-specific symptoms and sleep and circadian functioning, relative to UC-DT. Exploratory analysis will examine whether improvements in sleep and circadian functioning predict reduction in functional impairment and disorder-specific symptoms, and whether the intervention effects are mediated by improved sleep and circadian functioning and moderated by previously reported risk factors (demographics, symptom severity, medications, psychiatric and medical comorbidity).This trial tests an important and understudied mechanism-dysregulated sleep and circadian rhythms-in SMI, a novel transdiagnostic treatment approach, in a community setting so as to contribute to the goal of bridging the gap between research and practice.ClinicalTrials.gov identifier: NCT02469233 . Registered on 9 June 2015.
| S-EPMC5175375 | biostudies-literature
Project description:OBJECTIVE:Existing research has demonstrated that patient ratings of usefulness and ratings of utilization of treatment elements are associated with treatment outcome. Few studies have examined this relationship among adolescents and with an extended follow-up. This study examined the extent to which elements of the Transdiagnostic Sleep and Circadian Intervention (TranS-C) were rated by youth as useful and utilized 6-months and 12-months after treatment. METHOD:Participants were 64 adolescents with an evening circadian preference who were given TranS-C as a part of their participation in a NICHD-funded study. At 6-month and 12-month follow-up, they completed the Usefulness Scale, the Utilization Scale, a 7-day sleep diary assessing total sleep time (TST) and bedtime, and the Children's Morningness-Eveningness Preference Scale (CMEP). RESULTS:On average, adolescents rated treatment elements as moderately useful and they utilized the treatment elements occasionally. Ratings of usefulness were associated with TST at 6-month follow-up, but not with bedtime or CMEP. Ratings of utilization were associated with a change in bedtime from 6-month to 12-month follow-up, but not with TST or CMEP. Ratings of usefulness and utilization were associated with selected treatment outcome measures at both follow-ups. CONCLUSIONS:These findings have implications for understanding mechanisms of change following treatment.
| S-EPMC6864305 | biostudies-literature
Project description:BackgroundThis study examined the 6-month follow-up outcomes of the Transdiagnostic Sleep and Circadian Intervention (TranS-C), compared to Psychoeducation about sleep and health (PE).MethodsAdolescents (mean [SD] = 14.77 [1.84] years) with eveningness chronotype and "at-risk" in at least one of five health domains were randomized to receive TranS-C (n = 89) or PE (n = 87) at a university-based clinic. Primary outcomes were average weeknight total sleep time and bedtime calculated from sleep diary, a questionnaire measure of circadian preference, and composite risks in five health domains. Secondary outcomes were selected sleep diary indices, sleepiness, and self- and parent-reported sleep, parent-reported risks in five health domains.ResultsRelative to PE, TranS-C showed treatment effects through 6-month follow-up on only one primary outcome; namely eveningness circadian preference. TranS-C also showed treatment effects on two sleep and circadian secondary outcomes, including the Pittsburgh Sleep Quality Index and sleep-diary measured weeknight-weekend discrepancy in wakeup time. TranS-C did not show treatment effects on self-report or parent-report composite risks in five health domains. PE showed benefit, relative to TranS-C, from posttreatment to 6-month follow-up for reducing parent-reported behavioral health risk (secondary outcome).ConclusionsIn at-risk adolescents, the evidence supports the TranS-C treatment effects over six months on improving sleep and circadian functioning on selected outcomes but not on reducing risk in five health domains.
| S-EPMC7242125 | biostudies-literature
Project description:Sleep quality, circadian phase, and mood are highly interdependent processes. Remarkably, there is currently no self-report questionnaire that measures all three of these clinically significant functions: The aim of this project was to address this deficit. In Study 1, 720 participants completed a set of potential items was generated from existing questionnaires in each of the three domains and refined to follow a single presentation format. Study 2 used an independent sample (N = 498) to interrogate the latent structure. Exploratory factor analysis was used to identify a parsimonious, three-factor latent structure. Following item reduction, the optimal representation of sleep quality, circadian phase, and mood was captured by a questionnaire with three 5-item scales: Depressed Mood, Morningness, and Good Sleep. Confirmatory factor analysis found the three-scale structure provided adequate fit. In both samples, Morningness and Good Sleep were positively associated, and each was negatively associated with the Depressed Mood scale. Further research is now required to quantify the convergent and discriminant validity of its three face-valid and structurally replicated scales. The new sleep, circadian rhythms, and mood (SCRAM) questionnaire is the first instrument to conjointly measure sleep quality, circadian phase, and mood processes, and has significant potential as a clinical tool.
| S-EPMC5717824 | biostudies-literature
Project description:To develop a patient-reported outcome measure to assess sleep amongst people experiencing problems with alcohol or other drugs. Item development included secondary analyses of qualitative interviews with drug or alcohol users in residential treatment, a review of validated sleep measures, focus groups with drug or alcohol users in residential treatment, and feedback from drug or alcohol users recruited from community and residential settings. An initial version of the measure was completed by 549 current and former drug or alcohol users (442 in person and 107 online). Analyses comprised classical test theory methods, exploratory and confirmatory factor analysis, measurement invariance assessment, and item response theory (IRT). The initial measure (30 items) had good content and face validity and was named the Substance Use Sleep Scale (SUSS) by addiction service users. After seven items were removed due to low item-factor loadings, two factors were retained and labeled: "Mind and Body Sleep Problems" (14 items) and "Substance-Related Sleep Problems" (nine items). Measurement invariance was confirmed with respect to gender, age, and administration format. IRT (information) and classical test theory (internal consistency and stability) indicated measure reliability. Standard parametric and nonparametric techniques supported convergent and discriminant validity. SUSS is an easy-to-complete patient-reported outcome measure of sleep for people with drug or alcohol problems. It can be used by those concerned about their own sleep, and by treatment providers and researchers seeking to better understand, assess, and potentially treat sleep difficulties amongst this population. Further validity testing with larger and more diverse samples is now required.
| S-EPMC6018897 | biostudies-literature
Project description:BackgroundAlthough research on the implementation of evidence-based psychological treatments (EBPTs) has advanced rapidly, research on the sustainment of implemented EBPTs remains limited. This is concerning, given that EBPT activities and benefits regularly decline post-implementation. To advance research on sustainment, the present protocol focuses on the third and final phase-the Sustainment Phase-of a hybrid type 2 cluster-randomized controlled trial investigating the implementation and sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for patients with serious mental illness and sleep and circadian problems in community mental health centers (CMHCs). Prior to the first two phases of the trial-the Implementation Phase and Train-the-Trainer Phase-TranS-C was adapted to fit the CMHC context. Then, 10 CMHCs were cluster-randomized to implement Standard or Adapted TranS-C via facilitation and train-the-trainer. The primary goal of the Sustainment Phase is to investigate whether adapting TranS-C to fit the CMHC context predicts improved sustainment outcomes.MethodsData collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended and may continue for up to one year. CMHC providers will be recruited to complete surveys (N = 154) and a semi-structured interview (N = 40) on sustainment outcomes and mechanisms. Aim 1 is to report the sustainment outcomes of TranS-C. Aim 2 is to evaluate whether manipulating EBPT fit to context (i.e., Standard versus Adapted TranS-C) predicts sustainment outcomes. Aim 3 is to test whether provider perceptions of fit mediate the relation between treatment condition (i.e., Standard versus Adapted TranS-C) and sustainment outcomes. Mixed methods will be used to analyze the data.DiscussionThe present study seeks to advance our understanding of sustainment predictors, mechanisms, and outcomes by investigating (a) whether the implementation strategy of adapting an EBPT (i.e., TranS-C) to the CMHC context predicts improved sustainment outcomes and (b) whether this relation is mediated by improved provider perceptions of treatment fit. Together, the findings may help inform more precise implementation efforts that contribute to lasting change.Trial registrationClinicalTrials.gov identifier: NCT05956678 . Registered on July 21, 2023.
| S-EPMC10788981 | biostudies-literature
Project description:ObjectiveTo develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders.MethodsConstructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425).ResultsThe consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice.ConclusionWe have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings.
| S-EPMC4415910 | biostudies-literature
Project description:BackgroundPeople living with serious mental health conditions experience increased morbidity due to physical health issues driven by medication side-effects and lifestyle factors. Coordinated mental and physical healthcare delivered in accordance with a care plan could help to reduce morbidity and mortality in this population. Efforts to develop new models of care are hampered by a lack of validated instruments to accurately assess the extent to which mental health services users and carers are involved in care planning for physical health.ObjectiveTo develop a brief and accurate patient-reported experience measure (PREM) capable of assessing involvement in physical health care planning for mental health service users and their carers.MethodsWe employed psychometric and statistical techniques to refine a bank of candidate questionnaire items, derived from qualitative interviews, into a valid and reliable measure involvement in physical health care planning. We assessed the psychometric performance of the item bank using modern psychometric analyses. We assessed unidimensionality, scalability, fit to the partial credit Rasch model, category threshold ordering, local dependency, differential item functioning, and test-retest reliability. Once purified of poorly performing and erroneous items, we simulated computerized adaptive testing (CAT) with 15, 10 and 5 items using the calibrated item bank.ResultsIssues with category threshold ordering, local dependency and differential item functioning were evident for a number of items in the nascent item bank and were resolved by removing problematic items. The final 19 item PREM had excellent fit to the Rasch model fit (x2 = 192.94, df = 1515, P = .02, RMSEA = .03 (95% CI = .01-.04). The 19-item bank had excellent reliability (marginal r = 0.87). The correlation between questionnaire scores at baseline and 2-week follow-up was high (r = .70, P < .01) and 94.9% of assessment pairs were within the Bland Altman limits of agreement. Simulated CAT demonstrated that assessments could be made using as few as 10 items (mean SE = .43).DiscussionWe developed a flexible patient reported outcome measure to quantify service user and carer involvement in physical health care planning. We demonstrate the potential to substantially reduce assessment length whilst maintaining reliability by utilizing CAT.
| S-EPMC6373938 | biostudies-literature
Project description:Study objectivesTo develop an archive of self-report questions assessing sleep disturbance and sleep-related impairments (SRI), to develop item banks from this archive, and to validate and calibrate the item banks using classic validation techniques and item response theory analyses in a sample of clinical and community participants.DesignCross-sectional self-report study.SettingAcademic medical center and participant homes.ParticipantsOne thousand nine hundred ninety-three adults recruited from an Internet polling sample and 259 adults recruited from medical, psychiatric, and sleep clinics.InterventionsNone.Measurements and resultsThis study was part of PROMIS (Patient-Reported Outcomes Information System), a National Institutes of Health Roadmap initiative. Self-report item banks were developed through an iterative process of literature searches, collecting and sorting items, expert content review, qualitative patient research, and pilot testing. Internal consistency, convergent validity, and exploratory and confirmatory factor analysis were examined in the resulting item banks. Factor analyses identified 2 preliminary item banks, sleep disturbance and SRI. Item response theory analyses and expert content review narrowed the item banks to 27 and 16 items, respectively. Validity of the item banks was supported by moderate to high correlations with existing scales and by significant differences in sleep disturbance and SRI scores between participants with and without sleep disorders.ConclusionsThe PROMIS sleep disturbance and SRI item banks have excellent measurement properties and may prove to be useful for assessing general aspects of sleep and SRI with various groups of patients and interventions.
| S-EPMC2880437 | biostudies-literature
Project description:BackgroundPatient-reported outcomes (PROs) can be used to monitor patients during treatment. Healthcare provider preferences for individualized vs. standardized PROs have been understudied.MethodsThis study surveyed oncology and mental health providers to compare attitudes towards individualized and standardized PROs. We have developed a method for individualizing PROs, called precision PROs, and the survey specifically assessed preferences for this method. We compared attitudes and preferences by provider type and by whether respondents were current or never users of PROs.ResultsOncology providers expressed more positive attitudes for standardized PROs in treatment planning compared to mental health providers (F(1,440) = 5.978, p = 0.015). The interaction between provider type (oncology vs. mental health) and type of PRO (individualized vs. standardized) was not significant for the attitudes about the clinical utility of PROs (p = 0.709). When directly asked about the precision PRO approach, oncologists were less likely to prefer standardized items (OR = 0.478, p = 0.001) or have no preference (OR = 0.445, p = 0.007) to the precision PRO approach when compared to mental health providers. Qualitative analyses suggested standardized PROs may be simpler or easier to understand whereas individualized PROs better capture patient variability and the unique aspects of each patient's condition. Some mental health providers expressed reticence about letting patients choose how to tailor PROs. Never users of PROs reported more positive attitudes towards individualized measures than standardized measures whereas current users of PROs did not have a difference in attitudes (p = 0.010). User status was mostly unrelated to preferences.ConclusionResults suggest that healthcare provider preference for individualized PROs may differ by medical specialty. How PROs are tailored may need to differ by discipline. This is particularly important given that previous research showing a preference for individualized PROs over standardized was conducted with psychotherapists. Further research on patient preferences for individualized and standardized PROs is warranted as is research on the clinical utility of individualized PROs such as the precision PRO approach.
| S-EPMC8384935 | biostudies-literature