Sector-5 Sikar Road, India

The Sleep Course: an Online Sleep Intervention for Adults with Self-reported Sleep Difficulties

To improve access to effective psychological treatment, Internet-delivered Cognitive Behaviour Therapy (ICBT) has been developed. ICBT delivers therapeutic content via structured online lessons usually over several months, teaching the same skills that are taught in face-to-face cognitive behaviour therapy. In routine practice, ICBT is often accompanied by brief therapist support offered via secure messaging and/or phone calls. A growing body of research supports the effectiveness of ICBT for a variety of conditions, including depression, anxiety, alcohol misuse, and insomnia. For insomnia, ICBTi has been shown to result in improvements on various sleep measures, comorbid anxiety and depression, and quality of life, with outcomes comparable to face-to-face treatment. Importantly, there are a growing number of studies showing the effectiveness of ICBT for depression and anxiety extends to routine care. However, there are fewer studies exploring ICBTi in routine care, particularly when minimal exclusion criteria are imposed. This research is important because sleep difficulties and insomnia are common, distressing and often disabling and frequently comorbid with mood or anxiety disorders as well as various physical conditions. Moreover, access to specialized psychological services, such as CBTi, is often limited, despite CBTi being a well-established first-line treatment, which many clients find more acceptable than medication. Two key aspects of CBTi are stimulus control and sleep restriction though other strategies such as cognitive restructuring and relaxation are also commonly included. ICBTi offers a promising approach for expanding access to evidence-based treatment for insomnia. This is especially critical given the high personal and societal costs of leaving insomnia untreated. From past research, the investigators have found that approximately 73% of clients enrolled in the routine clinic that offers ICBT for anxiety and depression also reported significant sleep problems. Of these, only 30% accessed an additional sleep resource to address their sleep concerns. While improvements in sleep were observed among all clients enrolled in ICBT, average post-test treatment scores indicated many clients still had significant difficulties with insomnia. In another study conducted within the investigators' Unit, the investigators explored whether offering an insomnia-focussed lesson at the beginning of ICBT would improve insomnia symptoms. In this study, the investigators found that clients experienced large reductions in insomnia symptoms at a faster rate than when clients did not receive the insomnia lesson at the beginning of ICBT. However, even with these improvements, many clients continued to report clinically significant levels of insomnia post-treatment, indicating that further support for insomnia symptoms may be beneficial. Overall, given that the investigators ICBT program does not appear to be fully meeting the sleep needs of clients who have depression and anxiety, as well as the needs of clients who have sleep problems or insomnia and do not want ICBT for depression and anxiety, the investigators believe it would be valuable to explore the benefits of offering ICBTi in the routine care clinic. This is especially important for routine care settings where inclusivity is key and services should be broadly accessible. One such program that shows promise among clients with diverse sleep difficulties is the Sleep Course. The current study therefore aims to explore the extent to which this ICBTi program will be used by clients seeking services within the routine online clinic. Additionally, the study will explore the demographic and clinical characteristics of clients who seek ICBTi, as well as the acceptability and effectiveness of the ICBTi program. The data collected will shape long-term practices within the Online Therapy Unit and has potential to significantly enhance service delivery. The research will also provide valuable insights for other online clinics regarding the potential of offering ICBTi in routine online care. By exploring the program's use, client characteristics, acceptability, and effectiveness, this study will contribute to a broader understanding of how ICBTi can be successfully integrated into routine online services, ultimately improving access to evidence-based treatment for insomnia.

Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults

Creatine is a naturally occurring nitrogen containing compound endogenously produced in the body through reactions involving the amino acids arginine, glycine and methionine. Alternatively, creatine can be consumed in the diet (primarily from red meat and seafood) or through commercially manufactured creatine. It has been proposed that the strategic ingestion of creatine supplementation may be an important factor to consider during a resistance training program to increase muscle growth and performance. There is evidence that creatine supplementation only on training days has greater muscle benefits compared to placebo in healthy older adults. However, the effects of creatine on training days (compared to creatine on non-training days or placebo) in healthy young adults is unknown. Further, pre- and post-exercise creatine supplementation appears to produce similar muscle benefits (compared to placebo) in healthy older adults. It remains to be determined whether the timing of creatine ingestion (immediately before vs. immediately following training sessions) influences the physiological adaptations from resistance training compared to placebo in young healthy adults. It is also unknown whether differences exist in supplementing with creatine immediately before, during or immediately following resistance training sessions in young healthy adults.

Small Steps for Big Changes - Healthy Cities Implementation Science

In partnership with YMCAs in Canada spanning 8 provinces (overseeing 44 distinct community facilities/sites), the investigators will adapt and deliver our evidence-based diabetes prevention program, Small Steps for Big Changes. The purpose of this project is to evaluate the implementation and effectiveness of SSBC across diverse urban communities. Specifically, the investigators aim to: 1. Evaluate the implementation and sustainability of the program by examining the number of staff trained/patients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program. 2. Examine clinical-effectiveness of the program on: T2D status (self-report and HbA1c; primary outcomes), cardiorespiratory fitness, anthropometric (weight, waist circumference, resting heart rate), health behaviours (exercise, diet). 3. Examine cost-effectiveness of the program on: healthcare resource utilization, and health-related quality of life (secondary outcomes). Research Design: A hybrid type 2 implementation-effectiveness study design (Curran et al., 2012) with multi/mixed methods will be used to evaluate the implementation and effectiveness of SSBC. SSBC program: SSBC will be administered and facilitated by the community facility trainers at YMCA locations. SSBC consists of 6 sessions delivered over 4 consecutive weeks, with each session comprising brief (20-30 mins) counselling that support participants self-regulatory skills to promote independence and long-term adherence to healthy dietary behaviours and regular exercise, followed by 20-30 mins of supervised aerobic exercise.

Effects of Resistance-band Training and Creatine and Whey Protein

Sarcopenia, characterized by the age-related reduction in strength, muscle mass, and physical function, decreases the ability to perform activities of daily living. Physical inactivity and inadequate nutrition are contributing factors to the development of sarcopenia. Resistance training is a safe, viable and effective intervention which increases measures of muscle and bone mass, muscle performance (i.e., strength, endurance) and functional ability in older adults. However, older adults indicate that high costs and difficulty finding training programming and/or facilities are barriers to participating in resistance training. Home-based resistance-band training is safe, effective and serves as a viable alternative to traditional resistance training (i.e., involving free-weights and machine-based equipment). From a healthy aging perspective, resistance-band training elicits similar improvements in strength (primary indicator of sarcopenia) and functional ability compared to traditional resistance training in older adults. In addition to resistance training (involving resistance-bands), creatine and whey protein supplementations have also been shown to have favorable effects on measures of muscle, bone and functional ability in older adults. However, no study has examined the effects of resistance-band training and creatine and whey protein supplementation in older adults.

Effects of Resistance-band Training and Creatine Supplementation Strategies in Healthy Older Adults

Resistance-band training is safe, conveient, easy-to-use, eliminates potential barriers to exercise participation (i.e., lack of transportation to and from commercial training facilities) and results in high exercise compliance and adherence. Further, resistance-band training results in similar improvements in muscle performance and functional ability compared to traditional resistance-type training using free-weights and machines. Creatine is a naturally occurring nitrogen-containing compound produced in the body in the liver and brain and can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products. Evidence-based research shows that creatine supplementation, when ingested during a resistance exercise training program, improves measures of lean mass and muscle growth, muscle performance and functional ability. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.

Creatine Supplementation in Young Healthy Adults

Creatine is a naturally occurring compound produced in the liver and brain. Creatine can also be found in food products such as red meat and seafood or through commercially available manufactured creatine products (i.e. creatine supplementation). Evidence-based research shows that creatine supplementation improves measures of body composition and muscle performance. However, the optimal creatine supplementation protocol to achieve these benefits is unknown.

Pilot Study of the 'Thriving With PMDs' Program

Assessing Social Learning and Course Delivery Timing in Internet-delivered Cognitive Behaviour Therapy for Public Safety Personnel

Background---- Public Safety Personnel (PSP) are at an increased risk of developing mental disorders. PSP also face many barriers to accessing mental health services (e.g., stigma, location, time). The PSP Wellbeing Course is a transdiagnostic internet-delivered cognitive behaviour therapy (ICBT) course that has been specifically tailored to PSP. The effectiveness of the therapist-guided course and a self-guided course have both been supported. Consistent with the larger literature on self-guided ICBT, engagement with and outcomes of the self-guided PSP Wellbeing Course could be strengthened. Persuasive design describes using technology to influence human behaviour. The current study is designed to assess the impact of different timing options (i.e., tunneled vs. personalized) and increased social learning (i.e., standard versus enhanced social learning) on user experience, adherence, and outcomes in ICBT. Methods--- Participants will be recruited via posts on the PSPNET social media platforms (i.e., Twitter and Facebook) and emails distributed by PSP organizations. Members of the PSPNET team will also reach out to contacts within PSP organizations to ask them to tell their colleagues about the proposed research. All interested participants will be directed to the study website (www.pspnet.ca) to complete an online screening questionnaire. As part of this questionnaire, they will be presented with a consent form explaining the screening. After consent is given, clients will be assessed for eligibility using an online screening questionnaire. The online screening questionnaire captures demographic information (e.g., sex, ethnicity, location), information about depression and other mental health issues, and background information (e.g., medical history, mental health history, symptoms). After completing the questionnaires, participant responses will be reviewed by PSP staff for eligibility. Clients who are eligible will be randomized into one of four conditions. Participants who do not meet criteria, but are over the age of 18, will not be randomized and will instead be enrolled into the "treatment-as-usual" version of the course, which consists of a tunneled delivery and standard resources. Ineligible participants' data will not be included in analyses. Individuals under the age of 18 will not be eligible for any services.The two factors in the trial are: Factor 1: Tunneled course delivery or personalized course delivery Factor 2: Standard or enhanced social learning resources. As this is a factorial trial with two factors, each client will be randomized to one of four conditions: Condition 1: Tunneled Delivery and Standard Resources Condition 2: Tunneled Delivery and Enhanced Social Learning Resources Condition 3: Personalized Delivery and Standard Resources Condition 4: Personalized Delivery and Enhanced Social Learning Resources Randomization will occur within 2 business-days of completion of the screening questionnaires. All participants will receive the Self-Guided PSP Wellbeing Course, a transdiagnostic internet intervention. The program is an adaptation of a previous Australian course, the Wellbeing Course. The course involved 5 lessons that are typically completed over an 8 week period, though participants will have access to the course materials for up to 26 weeks. The content is focused on cognitive behavior therapy and relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills). All participants are presented with worksheets at the end of each lesson that contain exercises that facilitate skill acquisition. Participants will be sent automatic emails reminding them to stay engaged with the lessons and to complete questionnaires. Participants will complete questionnaires at screening, 4 weeks, 8 weeks (post-treatment), and 20 weeks (post-treatment).

Cessation of Somatostatin Analogues After PRRT in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours

Neuroendocrine tumours commonly originate from the gut and metastasise widely including to the liver, lymph nodes and bones. Originally called "carcinoid tumours", these cancers are most commonly treated with somatostatin analogues (SSA) first line. These analogues treat carcinoid syndrome and slow tumour growth. Despite SSA therapy, progression develops over time. Upon progression, peptide receptor radionuclide therapy (PRRT) is the next standard therapeutic option. After PRRT is initiated, it is unclear if continuing SSA injections is beneficial. There are reasons to believe it might be necessary to continue SSAs, but other reasons to believe they should cease. Given that SSA injections are expensive and associated with side effects, this study aims to clarify the utility of continuing SSA injections after progression on SSA therapy and commencement of PRRT. STOPNET aims to explore outcomes in grade 1 and 2 mid, hind gut or pancreatic neuroendocrine tumours, that have progressed on SSA therapy, are eligible to receive PRRT and in whom the SSA is either continued or ceased after PRRT is commenced. The two primary objectives include 1. To estimate the 20-month progression free survival rate after PRRT commencement in patients who cease and who continue SSA. 2. Feasibility as measured by: 1. Recruitment rate and 2. Patient acceptance of ceasing and staying off SSA over the 20 month follow up period. The study design of STOPNET is prospective, randomised, non-comparative, open label, multicentre phase II study. Patients meeting the inclusion and exclusion criteria will be randomised, prior to commencing PRRT, to either continue or cease SSA treatment. Randomisation will occur centrally in REDCap by the AGITG STOPNET study team. Randomisation will be 2:1 (the majority being randomised to cease SSA) and will be stratified by WHO tumour grade (1 V 2), sites of metastases (visceral only verse visceral and bone) and institution.

Neoadjuvant Chemotherapy, Excision And Observation vs Chemoradiotherapy For Rectal Cancer

This study is being done to find out if this approach is better or worse than the usual approach for early rectal cancer. The usual approach is defined as care most people get for early rectal cancer. The usual approach for patients who are not in a study is surgery to remove the rectum or treatment with chemotherapy and radiation therapy, followed by surgery. There are several chemotherapy drugs approved by Health Canada that are commonly used with radiation therapy. For patients who get the usual approach for this cancer, about 90 out of 100 are free of cancer after 5 years. If a patient decides to take part in this study, they will either get a combination of chemotherapy drugs called FOLFOX or CAPOX for up to 12 weeks or will get chemotherapy with radiation therapy for up to 6 weeks. After finishing treatment, and even if treatment is stopped early, the study doctor will watch for side effects and determine which type of surgery would be best. After surgery, patients will be asked to come in every 4 months for 2 years, then every 6 months for an additional year. Then will be checked every year for 2 years. This means seeing the study doctor for up to 5 years after surgery. Patients may be seen more often if your study doctor thinks it is necessary.