The uptake and outcomes of Internet cognitive behavioural therapy for health anxiety symptoms during the COVID-19 pandemic

Background: Internet cognitive behavioural therapy (iCBT) for health anxiety has demonstrated efficacy but has not been evaluated during the COVID-19 pandemic. This study presents the first evaluation of the uptake and outcomes of iCBT for health anxiety during the COVID-19 pandemic. Methods: THIS WAY UP is an Australian digital mental health service which delivers iCBT interventions to community members. We compared the uptake of THIS WAY UP's iCBT course for health anxiety in an Australian adult sample who started the course before the pandemic (12th September 2019–11 th March 2020) to during the pandemic (12th March to 11th June 2020). The course was accessible to Australian adults over 18 years old, with no inclusion criteria. Outcomes included course registrations and commencements, lesson and course completion, and self-reported health anxiety (Short Health Anxiety Inventory), depression (Patient Health Questionnaire 9-item) and distress (Kessler-10). Results: From March to June 2020, we observed significant increases in course registrations (N = 238 vs N = 1057); and course commencements (N = 126 vs. N = 778). Large, significant improvements in health anxiety (g = 0.89), and distress (K10: g = 0.91), and medium improvements in depression (g = 0.55) were found. Course completion during COVID was 30.5%. Conclusions: iCBT improved health anxiety during the COVID-19 pandemic, and provides scalable intervention that can address increased demands for mental health services in the community

Assessing site performance in the Altair study, a multinational clinical trial

Background: Reviewing clinical trial site performance identifies strategies to control outcomes. Performance across 5 geographical regions (36 sites across Asia, Australia, Europe, North America and Latin America) was investigated in a study that randomised 322 HIV-infected individuals. Methods: Regional performance was compared using descriptive analysis for time to site opening, recruitment, quality of data and laboratory samples. Follow-up consisted of 10 visits (96 weeks), electronic data collection (EDC) within 7 days of a visit and serious adverse events (SAEs) reported within 24 hours of site awareness. Results: Median days to site opening was 250 (188 to 266), ranging from 177 (158 to 200) (Australia) to 265 (205 to 270) (Europe). Median days to ethics and regulatory approval was 182 (120 to 241) and 218 (182 to 341) days, respectively. Within regions, time to approval ranged from 187 (91 to 205) days (Australia) to 276 (175 to 384) days (Europe). Time to first randomisation ranged from 282 (250 to 313) days (Australia) to 426 (420 to 433) days (North America). Conclusions: Population availability and time to ethics and regulatory approvals influence recruitment; therefore accurate feasibility assessments are critical to site selection. Time to ethics and regulatory approval may not limit site inclusion if compensated by rapid recruitment. Identifying potential delays and methods for reduction can decrease time and costs for sponsors. Trial registration: Clinical Trials.Gov identifier: NCT00335322. Date of registration: 8 June 2006

Bone turnover markers in HIV disease

Biomarkers are being increasingly used in basic and clinical research of HIV disease as well as clinical management of infected individuals. Bone metabolism can be assessed by measurement of bone turnover markers, molecules released during bone formation and removal of old bone (resorption). In HIV-infected adults, there is a higher prevalence of low bone mineral density and fractures compared to the general population. This review discusses the findings regarding bone turnover markers in HIV-uninfected and -infected populations and their potential role in assessing fracture risk and predicting bone loss. Studies in postmenopausal women and elderly men show that increased bone turnover markers levels are associated with bone loss, and high levels of resorption markers may predict fractures independently of bone mineral density. Several HIV-related factors, including HIV infection and inflammation, have been found to affect the balance between bone formation and resorption. Some clinical studies found increased levels of bone turnover markers in HIV-infected adults compared to uninfected controls. Furthermore, bone turnover marker levels increased following initiation or switch to different antiretroviral agents in recent randomized trials. The clinical value of bone turnover markers is currently limited due to different sources of variability and limited data from studies in HIV-infected populations. Further research is needed to explore the potential value of bone turnover markers as additional measurements to bone mineral density in fracture risk assessment and monitoring treatment-induced bone effects in HIV-infected patients

Bone disease in HIV-infected individuals and the effects of antiretroviral therapy

Bone loss and fractures are more common in HIV‐infected than HIV-uninfected adults. This thesis examined bone disease measures and related factors among HIV-infected adults who participated in two clinical trials of combination antiretroviral therapy.Three sub-studies in the STEAL trial investigated different aspects of bone health in virologically-suppressed adults randomised to either tenofovir/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC). The first study compared bone metabolism between arms and identified predictors of bone loss over 96 weeks. The second study evaluated bone structural parameters. The third study explored possible links between human leukocyte antigens (HLA) and BMD. Bone loss over 96 weeks was also examined in a sub-study of Second-Line, a study in adults from middle-income countries virologically failing standard first-line therapy, randomised to raltegravir+lopinavir/ritonavir or conventional 2-3 nucleoside/nucleotide reverse transcriptase inhibitor (N(t)RTIs)+lopinavir/ritonavir therapy.STEAL participants randomised to TDF/FTC experienced significantly greater BMD decrease compared to ABC/3TC. Bone markers also increased with TDF/FTC, but early changes in markers did not predict bone loss. Independent predictors of reduced BMD included randomisation to TDF/FTC, lower fat mass, lower bone formation, and PI use. Tenofovir use at the time of randomisation was associated with reduced bone structure measures, but no structural parameter changed significantly over 96 weeks. A possible association was found between BMD and HLA supertypes, particularly HLA-DQ3. In Second-Line, there were greater BMD decreases among N(t)RTI-recipients compared with raltegravir. Most of the BMD decrease occurred in the first 48 weeks of treatment with little change thereafter. Independent predictors for BMD decrease included lower baseline body mass index, longer tenofovir exposure, greater change in CD4+ from baseline to week 12, and higher baseline plasma HIV-RNA.Taken together, these studies contribute additional evidence regarding the complex relationship between HIV-infection, traditional risk factors, viral and immune mediators, antiretroviral therapy (particularly tenofovir) and bone quality. Further research might allow for more effective clinical management of HIV-infected patients at risk of bone disease and fractures

COVID-19 related differences in the uptake and effects of internet-based cognitive behavioural therapy for symptoms of obsessive-compulsive disorder

Background: The impacts of COVID-19 for people with obsessive-compulsive disorder (OCD) may be considerable. Online cognitive behavioural therapy (iCBT) programmes provide scalable access to psychological interventions, although the effectiveness of iCBT for OCD during COVID-19 has not been evaluated. Aim: This study investigated the uptake and effectiveness of iCBT for OCD (both self- and clinician-guided courses) during the first 8 months of the pandemic in Australia (March to October 2020) and compared outcomes with the previous year. Method: 1,343 adults (824/1343 (61.4%) female, mean age 33.54 years, SD = 12.00) commenced iCBT for OCD (1061 during the pandemic and 282 in the year before) and completed measures of OCD (Dimensional Obsessive-Compulsive Scale) and depression (Patient Health Questionaire-9) symptom severity, psychological distress (Kessler-10), and disability (WHO Disability Assessment Schedule) pre- and post-treatment. Results: During COVID-19, there was a 522% increase in monthly course registrations compared with the previous year, with peak uptake observed between April and June 2020 (a 1191% increase compared with April to June 2019). OCD and depression symptom severity were similar for the COVID and pre-COVID groups, although COVID-19 participants were more likely to enrol in self-guided courses (versus clinician-guided). In both pre- and during-COVID groups, the OCD iCBT course was associated with medium effect size reductions in OCD (g = 0.65-0.68) and depression symptom severity (g = 0.56-0.65), medium to large reductions in psychological distress (g = 0.77-0.83) and small reductions in disability (g = 0.35-.50). Conclusion: Results demonstrate the considerable uptake of online psychological services for those experiencing symptoms of OCD during COVID-19 and highlight the scalability of effective digital mental health services. </p

A Comparison of the Sodium Content of Supermarket Private-Label and Branded Foods in Australia

Supermarket private-label products are perceived to be lower quality than their branded counterparts. Excess dietary sodium in foods contributes to high blood pressure and cardiovascular disease. Sodium concentrations in products are an important indicator of quality. We compared the sodium content of 15,680 supermarket private-label and branded products, available in four Australian supermarkets between 2011–2013, overall and for 15 food categories. Mean sodium values were compared for: (1) all products in 2013; (2) products in both 2011 and 2013; and (3) products only in 2013. Comparisons were made using paired and unpaired t tests. In each year the proportion of supermarket private-label products was 31%–32%, with overall mean sodium content 17% (12%–23%) lower than branded products in 2013 (p ≤ 0.001). For products available in both 2011 and 2013 there was a ≤2% (1%–3%) mean sodium reduction overall with no difference in reformulation between supermarket private-label and branded products (p = 0.73). New supermarket private-label products in 2013 were 11% lower in sodium than their branded counterparts (p = 0.02). Supermarket private-label products performed generally better than branded in terms of their sodium content. Lower sodium intake translates into lower blood pressure; some supermarket private-label products may be a good option for Australians needing to limit their sodium intake

Is Butter Back? A Systematic Review and Meta-Analysis of Butter Consumption and Risk of Cardiovascular Disease, Diabetes, and Total Mortality.

Dietary guidelines recommend avoiding foods high in saturated fat. Yet, emerging evidence suggests cardiometabolic benefits of dairy products and dairy fat. Evidence on the role of butter, with high saturated dairy fat content, for total mortality, cardiovascular disease, and type 2 diabetes remains unclear. We aimed to systematically review and meta-analyze the association of butter consumption with all-cause mortality, cardiovascular disease, and diabetes in general populations.We searched 9 databases from inception to May 2015 without restriction on setting, or language, using keywords related to butter consumption and cardiometabolic outcomes. Prospective cohorts or randomized clinical trials providing estimates of effects of butter intake on mortality, cardiovascular disease including coronary heart disease and stroke, or diabetes in adult populations were included. One investigator screened titles and abstracts; and two reviewed full-text articles independently in duplicate, and extracted study and participant characteristics, exposure and outcome definitions and assessment methods, analysis methods, and adjusted effects and associated uncertainty, all independently in duplicate. Study quality was evaluated by a modified Newcastle-Ottawa score. Random and fixed effects meta-analysis pooled findings, with heterogeneity assessed using the I2 statistic and publication bias by Egger's test and visual inspection of funnel plots. We identified 9 publications including 15 country-specific cohorts, together reporting on 636,151 unique participants with 6.5 million person-years of follow-up and including 28,271 total deaths, 9,783 cases of incident cardiovascular disease, and 23,954 cases of incident diabetes. No RCTs were identified. Butter consumption was weakly associated with all-cause mortality (N = 9 country-specific cohorts; per 14g(1 tablespoon)/day: RR = 1.01, 95%CI = 1.00, 1.03, P = 0.045); was not significantly associated with any cardiovascular disease (N = 4; RR = 1.00, 95%CI = 0.98, 1.02; P = 0.704), coronary heart disease (N = 3; RR = 0.99, 95%CI = 0.96, 1.03; P = 0.537), or stroke (N = 3; RR = 1.01, 95%CI = 0.98, 1.03; P = 0.737), and was inversely associated with incidence of diabetes (N = 11; RR = 0.96, 95%CI = 0.93, 0.99; P = 0.021). We did not identify evidence for heterogeneity nor publication bias.This systematic review and meta-analysis suggests relatively small or neutral overall associations of butter with mortality, CVD, and diabetes. These findings do not support a need for major emphasis in dietary guidelines on either increasing or decreasing butter consumption, in comparison to other better established dietary priorities; while also highlighting the need for additional investigation of health and metabolic effects of butter and dairy fat

Internet-based cognitive behavioural therapy for treating symptoms of obsessive compulsive disorder in routine care

A growing evidence base supports the efficacy of Internet-based cognitive behavior therapy (iCBT) for obsessive compulsive disorder (OCD). However, very few studies have evaluated the effectiveness of iCBT for OCD in routine care settings which service the bulk of a population's health needs. This study evaluated the treatment outcomes of 309 adults who enrolled in an online CBT course for their symptoms of OCD. Most patients (62.8%) enrolled in a self-help or unguided iCBT course, and the remainder were supported by a routine care, community clinician. The entire iCBT course was completed by 39.3% of participants, with 61.2% completing the majority of iCBT lessons. Higher baseline depression symptom severity predicted poorer adherence, while the presence of a supervising clinician was associated with greater adherence. Medium effect size reductions in OCD symptom severity (g = 0.61), depression symptom severity (g = 0.56), and psychological distress (g = 0.69) were observed from pre-to post-treatment. Pre-treatment OCD and depression symptom severity predicted post-treatment OCD symptom severity. Current results support the use of iCBT for OCD in routine care settings, and as health care resources are finite, iCBT for OCD may serve as a useful, low-intensity, and scalable addition to the existing healthcare infrastructure.</p

The effectiveness of internet-delivered cognitive behavioural therapy for health anxiety in routine care

Introduction: Randomised controlled trials have shown that internet-delivered cognitive behavioural treatment (iCBT) is an effective treatment for health anxiety, but the effectiveness of these programs in routine care has not been investigated. This study examined the effectiveness of iCBT for health anxiety symptoms in routine care settings in the community. Methods: Using an open-trial design, we investigated adherence to, and effectiveness of a 6-lesson iCBT program for health anxiety symptoms amongst individuals (n = 391, mean age 41 years, 64% female) who enrolled in the program either self-guided (n = 312) or under the supervision of community clinicians (general practitioners, psychologists and other allied health professionals) (n = 79). Primary outcome was health anxiety severity on the Short Health Anxiety Inventory (SHAI), and secondary outcomes were depression severity on the Patient Health Questionnaire 9-item (PHQ-9) (depression) and distress (Kessler-10: K-10). Results: Adherence to the iCBT program was modest (45.6% in the clinician-supervised group, 33.0% in the unguided group), but within-subjects effect sizes were large (SHAI: g = 1.66, 95%CI: 1.45–1.88; PHQ-9: g = 1.12, 95%CI: 0.92–1.32; K-10: g = 1.35, 95%CI: 1.15–1.56). Limitations: No control group, lack of follow-up data. Conclusions: iCBT is an effective treatment for health anxiety symptoms in routine care, but methods to increase adherence are needed to optimise benefits to participants. Randomised controlled effectiveness trials with long-term follow-up are needed.</p

Hip structural parameters over 96 weeks in HIV-infected adults switching treatment to Tenofovir-Emtricitabine or Abacavir-Lamivudine

Background: Therapy with tenofovir is associated with lower bone mineral density (BMD), higher markers of bone turnover and increased fracture risk in HIV-infected adults. Bone structural parameters generated by hip structural analysis may represent a separate measure of bone strength, but have not been assessed in HIV. Methods: Dual-energy X-ray absorptiometry (DXA) scans from 254 HIV-infected adults randomised to simplify their existing dual nucleoside analogue reverse transcriptase inhibitor therapy to coformulated tenofovir-emtricitabine or abacavirlamivudine were analysed using DXA-derived hip structural analysis software. Hip structural parameters included femoral strength index, section modulus, cross-sectional area, and cross-sectional moment of inertia. We used one-way ANOVA to test the relationship between nucleoside analogue type at baseline and structural parameters, multivariable analysis to assess baseline covariates associated with femoral strength index, and t-tests to compare mean change in structural parameters over 96 weeks between randomised groups. Results: Participants taking tenofovir at baseline had lower section modulus (-107.3 mm², p = 0.001), lower cross-sectional area (-15.01 mm³, p = 0.001), and lower cross-sectional moment of inertia (-2,036.8 mm⁴, p = 0.007) than those receiving other nucleoside analogues. After adjustment for baseline risk factors, the association remained significant for section modulus (p = 0.008) and cross-sectional area (p = 0.002). Baseline covariates significantly associated with higher femoral strength index were higher spine T-score (p = 0.001), lower body fat mass (p<0.001), lower bone alkaline phosphatase (p = 0.025), and higher osteoprotegerin (p = 0.024). Hip structural parameters did not change significantly over 96 weeks and none was significantly affected by treatment simplification to tenofovir-emtricitabine or abacavir-lamivudine. Conclusion: In this population, tenofovir use was associated with reduced composite indices of bone strength as measured by hip structural analysis, but none of the structural parameters improved significantly over 96 weeks with tenofovir cessation.Hila Haskelberg, Nicholas Pocock, Janaki Amin, Peter Robert Ebeling, Sean Emery, Andrew Carr, on behalf of the STEAL Study Grou