Authors
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Dr. Milena Gandy -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2022
INTERVENTION: The interventions, the Wellbeing Neuro Course, is an internet‐delivered psychological intervention developed at the eCentreClinic. It consists of: (a) 6 online lessons provided over 10 weeks. The Lessons will include information about identifying symptoms of poor wellbeing including mental health and cognitive difficulties, and teach practical skills for their self‐ management including; managing thoughts, low mood and anxiety, problem solving, memory and attention, and activity and fatigue levels. The intervention includes guidance and examples on how to adopt core psychological skills into one’s day‐to‐day life, including three comprehensive case stories of adults with neurological disorders (b) Optional worksheets for each lesson to aid the practice of core skills. Participants are strongly encouraged but not required to complete these worksheets throughout the course. (c) Optional additional written resources, which include information about other important skills, such as problem solving common cognitive difficulties, assertiveness and communication skills and techniques for managing sleep difficulties. Participants are encouraged but not required to read through these relevant written resources. (e) The option of brief contact with a psychologist via secure email or telephone throughout the course. Participants will be encouraged to complete a lesson every 10 days and complete some basic home based activities in the following 10 days. All lessons can be downloaded and printed. Participants are encouraged to complete the course with a support person if available (e.g., partner, carer). Participants will be contacted by a psychologist throughout the course to monitor their progress through the Course; Psychologists from the Multiple Sclerosis Clini CONDITION: Mental Health ‐ Depression Mental Health ‐ Anxiety Multiple Sclerosis;Depression;Anxiety; ; Multiple Sclerosis ; Depression ; Anxiety Neurological ‐ Multiple sclerosis PRIMARY OUTCOME: Generalized Anxiety Disorder 7‐Item (GAD‐7), which is a measure of anxiety.[Baseline (pre‐intervention), and 6 weeks (mid‐intervention), 11 weeks (post‐intervention/ primary endpoint), as well as at 3‐ and 12‐months post‐intervention commencement.] World Health Organisation Disability Assessment Schedule 2.0 (WHODAS‐2), which is a measure of disability associated with living with a chronic health condition.[Baseline (pre‐intervention), and 6 weeks (mid‐intervention), 11 weeks (post‐intervention/ primary endpoint), as well as at 3‐ and 12‐months post‐intervention commencement.] Patient Health Questionnaire 9‐Item (PHQ‐9), which is a measure of depression.[Baseline (pre‐intervention), and 6 weeks (mid‐intervention), 11 weeks (post‐intervention/ primary endpoint), as well as at 3‐ and 12‐months post‐intervention commencement.] INCLUSION CRITERIA: (a) Confirmed diagnosis of Multiple Sclerosis (b) Experiencing difficulties with their emotional and/or cognitive health (c) 18+ years of age (d) Living in Australia SECONDARY OUTCOME: Neuro‐QoL (Quality of Life in Neurological Disorders): Cognitive Function, which is a measure of perceived difficulties in cognitive abilities (e.g., attention, memory and decision making, or in the application of such abilities to everyday tasks)[Baseline (pre‐intervention), and 6 weeks (mid‐intervention), 11 weeks (post‐intervention), as well as at 3‐ and 12‐months post‐intervention commencement.] Compensatory Cognitive Strategies Questionnaire (CCSQ), which is a measure of the use of compensatory cognitive strategies before and after the intervention. [Baseline (pre‐intervention), and 6 weeks (mid‐intervention), 11 weeks (post‐intervention), as well as at 3‐ and 12‐months post‐intervention commencement.] During Therapy Questionnaire (DTQ), which is a purpose‐built measure to record additional therapy and changes to medication participants may have experienced during the therapy. [11 weeks post‐intervention commencement.] Neuro‐QoL (Quality of Life in Neurological Disorders): Emotional and Behavioural Dyscontrol, which is a measure of irritability, disinhibition, emotional lability, impatience and impulsivenenss.[Baseline (pre‐intervention), 11 weeks (post‐intervention), as well as at 3‐ and 12‐months post‐intervention commencement.] Skills Use questionnaire, which is a brief, purpose‐built measure to understand if participants are still using skills, and what skills, at follow‐up [3‐ and 12‐months post‐intervention commencement.] Fatigue Severity Scale (FSS), which is a measure of the severity of fatigue and its impact on a person’s activities and lifestyle in patients with a variety or chronic health disorders[Baseline (pre‐intervention), 11 weeks (post‐intervention), as well as at 3‐ and 12‐months post‐intervention commencement.] Treatment Satisfaction Questionnaires (TSQ), which is a purpose‐built measure of the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment. [11 weeks post‐intervention commencement.]
Epistemonikos ID: da5804a12ecdd55b0a47bd5982a961f17f373a5d
First added on: Aug 25, 2024