Is the Hospital Anxiety and Depression Scale (HADS) a valid measure in a general population 65-80 years old? A psychometric evaluation study.
Ingrid Djukanovic, Jörg Carlsson, Kristofer Årestedt
https://pubmed.ncbi.nlm.nih.gov/28978356/Actively Recruiting
Led by University of Toronto · Updated on 2024-12-04
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating a 12-week behavioral intervention designed to reduce sedentary behavior among prostate cancer survivors PCS. The study compares this intervention, which includes FitBit use and six behavioral support sessions guided by the Multi-Process Action Control M-PAC framework, to a control group that receives only a FitBit and access to public health physical activity resources. The study aims to measure changes in sedentary behavior immediately after the intervention and six months later, while also assessing impacts on physical activity, motivation, sleep quality, social support, physical function, quality of life, fatigue, disability, and mental health. Participants in the intervention group receive a FitBit Inspire 2 and six remote behavior change sessions delivered bi-weekly by a movement specialist, including four one-on-one sessions and two group webinars. They will monitor daily steps and work to increase their baseline step count progressively across phases. The control group receives the same FitBit device and an orientation session but only access to publicly available active living resources without additional behavioral support. The intervention sessions focus on planning, goal setting, social support, and habit formation based on the M-PAC theoretical framework. During the study, participants will wear activPAL inclinometers to objectively measure changes in sedentary behavior and physical activity at baseline, after the 12-week intervention, and at a 6-month follow-up. Self-reported sedentary behavior and physical activity will also be assessed using validated questionnaires. Researchers will monitor motivational factors, sleep, social support, physical function, and patient-reported outcomes such as quality of life, fatigue, disability, and mental health. The total participation involves these assessments across the intervention and follow-up periods, with data collected remotely.
CONDITIONS
A Intervention for Reducing Sedentary Behaviour Among Prostate Cancer Survivors
L
Linda Trinh, PhD
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University of Toronto
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person) for eligibility assessment
Duration - 2 weeks
Participants maintain their regular movement routine to establish baseline daily average step count.
1 baseline visit with movement specialist and FitBit orientation
Duration - 12 weeks
Participants receive a 12-week behavioural intervention involving self-regulatory strategies to reduce sedentary behaviour and increase daily step counts, supported by 6 remotely-delivered sessions including one-on-one and group webinars.
Bi-weekly remotely-delivered sessions totaling 6 sessions (4 one-on-one and 2 group webinars)
Duration - 6 months post-intervention
Participants are assessed at 6 months after the intervention to evaluate the maintenance of behaviour changes.
1 follow-up assessment visit
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23899190/University of Toronto
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor