None listed
Conditions
Brief summary
This randomised, within subject, longitudinal trial will determine the efficacy of Functional Remediation as an early intervention in young people with mood disorder/psychosis who have increased Cardio Metabolic Syndrome risk factors and cognitive difficulties, as determined by their referring clinician. Specifically this trial aims to demonstrate that Functional Remediation will: aim 1: improve quality of life in young outpatients with a mood disorder/psychoses aim 2: improve mental health by delaying progression of illness and promote longer periods between lapse/relapse aim 3: modify sleep-wake behaviour, mood and general health (targeting cardio-metabolic outcomes) to improve social educational and functional skills, educational/employment/retention/return aim 4: to examine the role of change in cardio-metabolic characteristics with the cohort and following the intervention
Interventions
The YES intervention program consists of 3 eight week terms over a year. Between each term is a 3 week washout period, when the intervention programs are not run.
This randomised, crossover, longitudinal study has two arms. Each arm of the trial requires 4 hours per week or 32 hours of treatment over a 8 week period. The treatment period consists of 16 weeks with a 3 week washout period between treatment arms.
arm A: randomised as an "A"
This arm of the trial focuses on social interaction an
The YES intervention program consists of 3 eight week terms over a year. Between each term is a 3 week washout period, when the intervention programs are not run. This randomised, crossover, longitudinal study has two arms. Each arm of the trial requires 4 hours per week or 32 hours of treatment over a 8 week period. The treatment period consists of 16 weeks with a 3 week washout period between treatment arms. arm A: randomised as an "A" This arm of the trial focuses on social interaction and well being. There are two weekly interventions: anxious art(2.5 hrs) and Buddhist Mindfulness (1.5hrs) Participants can attend one or both of the workshops within their stream. Interventions are based on social exposure principals which encourage and support participants to practise self soothing and coping strategies and promote illness insight, reduction in disorder symptoms. Adherence to the program is encouraged through weekly text and e-mail reminders about intervention times and venues. Attendance, per intervention session is collected and included in the main data base. Study measures are collected at baseline prior to randomisation, week 1 of the term and are repeated at week 8 of the term. After the washout period, measures are again repeated at week one and week eight of the second intervention period. Follow up is at 12 months
Sponsors
Professor Ian Hickie
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
14 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
Help seeking young people aged between 14 and 25 with mood disorder/psychosis who have increased Cardio Metabolic Syndrome risk factors, social and cognitive difficulties as determined by their treating doctor/clinician. Must speak fluent english
Exclusion criteria
suffer from intellectual disability, major neurological disorder, or a major medical illness which impacts on cognition; history of sustained head injury; poor english skills; florid psychotic symptoms/florid mania; likely to require acute clinical care; current substance dependance.
Outcome results
None listed