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Transdiagnostic Internet-delivered cognitive behaviour therapy with therapist support offered once-weekly or once-weekly supplemented with therapist support within one-business-day: Pragmatic randomized controlled trial.

ABSTRACT: In routine care, internet-delivered cognitive behaviour therapy (iCBT) regularly includes therapist support delivered via secure email, but the optimal response time to emails is unknown. In this study, we compared the benefits of therapists providing support once-weekly versus therapists providing support once-weekly supplemented with a one-business-day response to all patient emails. This pragmatic randomized controlled trial included therapists employed by a specialized iCBT clinic or community mental health clinics, where providing iCBT is a secondary service. Patients with depression and/or anxiety who enrolled in transdiagnostic iCBT (5 core lessons over 8 weeks) were randomized to: 1) once-weekly support supplemented with a one-business-day response to patient emails by specialized therapists (n = 233); 2) once-weekly support also offered by specialized therapists (n = 216); or 3) once-weekly support offered by community clinic therapists (n = 226). Outcomes were measured at 8, 12, 24, and 52-weeks post-enrollment. Patient engagement and treatment experiences (e.g., treatment satisfaction, therapist alliance) were also assessed and a focus group was conducted with therapists. Supplementing once-weekly therapist support with a one-business-day response to patient emails resulted in therapists sending more emails to patients (M: 13 versus 9) and required more therapist time over treatment (M: 155 versus 109 min), but was not associated with improved outcomes, patient engagement or treatment experiences. All groups showed large improvements in symptoms of depression and anxiety maintained at 52-week follow-up, strong engagement and positive treatment experiences. Therapists viewed challenges of responding to patient emails within one-business-day to outweigh benefits. Contrary to expectations, supplementing once-weekly therapist support with a one-business-day response to all patient emails did not benefit patients and increased therapist time as well as therapist challenges when delivering iCBT in routine care.

SUBMITTER: Hadjistavropoulos HD

PROVIDER: S-EPMC7508705 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:With the growing demand for internet-delivered cognitive behavioural therapy (iCBT), this pragmatic factorial (2 × 2 × 2) randomized controlled trial evaluated strategies for facilitating iCBT engagement and outcomes in routine care. Specifically, the benefits to patients and therapists of using homework reflection questionnaires and offering patients twice-weekly therapist support were examined. Patients (n = 632) accepted into iCBT for depression and/or anxiety were randomly assigned to complete homework reflection questionnaires or not (factor 1), receive once- or twice-weekly support (factor 2), and to receive care from therapists employed in one of two settings (iCBT clinic or a community mental health clinic; factor 3). Outcomes were measured at pre-treatment, and 8, 12, and 24-weeks post-enrollment. Therapist time was tracked and a focus group was conducted to examine therapist experiences. No differences in patient outcomes were found between therapists employed in the two settings; as such, these two groups were combined for further analyses. In terms of engagement, homework reflection questionnaires were associated with fewer website log-ins and days accessing iCBT; twice-weekly support was associated with more patient emails sent to therapists. Despite engagement differences, homework reflection questionnaires and twice-weekly support did not significantly impact primary outcomes; all groups showed large improvements in depression and anxiety that were maintained at 24-week follow-up. Therapists perceived a number of benefits and challenges associated with responding to homework reflection questionnaires and offering twice-weekly support; most notably the strategies did not benefit all patients. Twice-weekly support was associated with increased therapist time and organizational challenges. It is concluded that neither completion of homework questionnaires nor offering twice-weekly support significantly improve iCBT in routine care.

Project description:OBJECTIVES:Social anxiety disorder (SAD) is one of the most common psychiatric disorders in youth, with a prevalence of about 3%-4% and increased risk of adverse long-term outcomes, such as depression. Cognitive-behavioural therapy (CBT) is considered the first-line treatment for youth with SAD, but many adolescents remain untreated due to limited accessibility to CBT. The aim of this study was to develop and evaluate the feasibility and preliminary efficacy of a therapist-guided internet-delivered CBT treatment, supplemented with clinic-based group exposure sessions (BIP SOFT). DESIGN:A proof-of-concept, open clinical trial with 6-month follow-up. PARTICIPANTS:The trial was conducted at a child and adolescent psychiatric research clinic, and participants (n=30) were 13-17 years old (83% girls) with a principal diagnosis of SAD. INTERVENTION:12 weeks of intervention, consisting of nine remote therapist-guided internet-delivered CBT sessions and three group exposure sessions at the clinic for the adolescents and five internet-delivered sessions for the parents. RESULTS:Adolescents were generally satisfied with the treatment, and the completion rate of internet modules, as well as attendance at group sessions, was high. Post-treatment assessment showed a significant decrease in clinician-rated, adolescent-rated and parent-rated social anxiety (d=1.17, 0.85 and 0.79, respectively), as well as in general self-rated and parent-rated anxiety and depression (d=0.76?and 0.51), compared with pretreatment levels. Furthermore, 47% of participants no longer met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for SAD at post-treatment. At a 6-month follow-up, symptom reductions were maintained, or further improved, and 57% of participants no longer met criteria for SAD. CONCLUSION:Therapist-guided and parent-guided internet-delivered CBT, supplemented with a limited number of group exposure sessions, is a feasible and promising intervention for adolescents with SAD. TRIAL REGISTRATION NUMBER:NCT02576171; Results.

Project description:Anaemia is a common complication of chronic kidney disease and prevalence increases with declining renal function. Renal anaemia has significant implications for the well-being and quality of life of patients and impacts on morbidity and mortality. Anaemia can be well managed by therapy with erythropoiesis-stimulating agents (ESAs). Previous clinical trials have shown that the only human cell-line-derived ESA, epoetin delta, is well tolerated and effective in maintaining haemoglobin levels in anaemic patients with chronic kidney disease. The half-life of epoetin delta suggests that administration of this agent is feasible once weekly and once every two weeks. We report on the design and rationale of a trial to compare once weekly vs. twice weekly, and once weekly vs. once every two weeks dosing of epoetin delta.This is a randomized, open-label, multicentre trial. Patients aged 18 years or above with chronic kidney disease (Stages 3-5) are eligible to enter this trial. Two groups of patients form the trial population, those naïve to ESA therapy and those previously stable on ESA therapy. There are two primary objectives of this trial: 1) to demonstrate non-inferiority between twice weekly and once weekly dosing of epoetin delta in previously naïve patients (assessed by haemoglobin at Week 24); 2) to demonstrate non-inferiority between once weekly and once every two weeks dosing in previously stable patients (assessed by average haemoglobin over Weeks 16-24). Among the secondary analyses will be assessments of haematocrit, number(%) of patients meeting predefined targets for haemoglobin and haematocrit levels, and comparisons of average dose. All patients will receive study medication for 24 weeks and dose will be adjusted according to a predefined algorithm to achieve and maintain haemoglobin >or= 11 g/dL. All patients completing this trial are eligible to enter a 2-year follow-up study to enable monitoring of emergent adverse events, anti-erythropoietin antibody responses, maintenance of efficacy and changes in diabetic retinopathy status.To our knowledge, this trial is the first to randomize ESA-naïve patients to different dosing regimens of the same ESA. Data generated will help in guiding the most appropriate dosing frequency for epoetin delta, particularly in those patients new to epoetin delta therapy.ClinicalTrials.gov: NCT00450333.

Project description:BackgroundA once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is used to treat obesity in adults, but assessment of the drug in adolescents has been lacking.MethodsIn this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (12 to <18 years of age) with obesity (a body-mass index [BMI] in the 95th percentile or higher) or with overweight (a BMI in the 85th percentile or higher) and at least one weight-related coexisting condition. Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary end point was the percentage change in BMI from baseline to week 68; the secondary confirmatory end point was weight loss of at least 5% at week 68.ResultsA total of 201 participants underwent randomization, and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was -16.1% with semaglutide and 0.6% with placebo (estimated difference, -16.7 percentage points; 95% confidence interval [CI], -20.3 to -13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, lipids [except high-density lipoprotein cholesterol], and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.ConclusionsAmong adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone. (Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189.).

Project description:IntroductionOnce-weekly subcutaneous semaglutide, a glucagon-like peptide-1 analog, is approved in the USA as an adjunct to diet and exercise for adults with inadequately controlled type 2 diabetes (T2D) to improve glycemic control and reduce the risk of major adverse cardiovascular events in people with T2D and established cardiovascular disease. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) phase III clinical trial program demonstrated the efficacy and safety of once-weekly subcutaneous semaglutide; however, determining its effectiveness in a real-world setting could support decision-making by clinicians, payers and policy makers in routine clinical practice.Research design and methodsSEmaglutide PRAgmatic (SEPRA) is an ongoing open-label, randomized, pragmatic clinical trial designed to compare the effects of once-weekly subcutaneous semaglutide versus standard of care in US health-insured adults with T2D and physician-determined inadequate glycemic control. The primary end point is the proportion of participants achieving glycated hemoglobin (HbA1c) <7.0% at year 1; other key outcomes include glycemic control, weight loss, healthcare utilization, and patient-reported outcomes. Individual-level data will be collected from routine clinical practice and health insurance claims. The last patient last visit is expected by June 2023.ResultsBetween July 2018 and March 2021, 1278 participants were enrolled from 138 study sites across the USA. At baseline, 54% were male with mean±SD age 57.4±11.1 years and body mass index 35.7±8.0 kg/m2. Mean diabetes duration was 7.4±6.0 years and mean HbA1c was 8.5±1.6%. At baseline, concomitant antidiabetes medications included metformin, sulfonylureas, sodium-glucose co-transporter-2 inhibitors, and dipeptidyl peptidase-4 inhibitors. The majority of participants had hypertension and dyslipidemia. The trial design was self-assessed using the PRagmatic Explanatory Continuum Indicator Summary-2 tool by the study steering group and was scored 4-5 in all domains suggesting a highly pragmatic study.ConclusionsSEPRA, a highly pragmatic ongoing study, will provide data on the effects of once-weekly subcutaneous semaglutide in a real-world setting when used during routine management of T2D.Trial registration numberNCT03596450.Trial registration number

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Transdiagnostic Internet-delivered cognitive behaviour therapy with therapist support offered once-weekly or once-weekly supplemented with therapist support within one-business-day: Pragmatic randomized controlled trial.

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