None listed
Conditions
Brief summary
Depressive disorders are highly prevalent and are the leading cause of disability in young people worldwide. While there is an increasing evidence base regarding effective treatments for youth depression, interventions that are recommended by the Australian clinical practice guidelines, such as cognitive behavioural therapy (CBT), are only modestly effective in this age group. There is an urgent need for additional treatment strategies to treat current problems as well as prevent the onset of secondary or comorbid mental disorders and disability. One such strategy that has an emerging evidence-base is physical activity as an augmentation or adjunct treatment. Physical activity is a low-stigma intervention with few side effects, factors that are important to help-seeking young people. This project aims to evaluate the effectiveness of a brief physical activity intervention that is integrated into usual clinical care in reducing depression and increasing engagement in physical activity in help-seeking young people. All allied health professionals at selected headspace centres (enhanced primary care youth mental health services) will be invited to take part in the project and those who participate will be offered training in the delivery of the intervention and a treatment manual. All help-seeking young people aged 12-25 years who present to the selected headspace centres will be screened for eligibility to participate in a cluster randomised controlled trial (RCT). Clinicians will be randomised to be trained in and to deliver either the physical activity intervention (active condition) or the psychoeducation (control condition) in addition to routine clinical care. Young people who consent to take part will be allocated to receive treatment from a clinician who has been randomised to deliver either the physical activity intervention or psychoeducation on physical activity in addition to treatment as usual. The primary hypothesis is that the physical activity intervention will lead to greater reductions in depressive symptoms compared to treatment as usual. The secondary hypothesis is, a) that the physical activity intervention will lead to: i) reduction in anxiety symptoms; and ii) improvements in functioning, when compared to treatment as usual; b) that changes in depressive symptoms will be mediated by increased physical activity.
Interventions
Participants will receive either a physical activity intervention, based on a behavioural activation framework, in addition to routine clinical care (psychological therapy of the clinician’s choice), or psycho-education on physical activity and routine clinical care. The interventions will be integrated into routine clinical care at headspace centres and delivered by an allied health professional. The intervention will be delivered in an average of 4 treatment sessions (each session is usually 5
Participants will receive either a physical activity intervention, based on a behavioural activation framework, in addition to routine clinical care (psychological therapy of the clinician’s choice), or psycho-education on physical activity and routine clinical care. The interventions will be integrated into routine clinical care at headspace centres and delivered by an allied health professional. The intervention will be delivered in an average of 4 treatment sessions (each session is usually 50 minutes in duration) across approximately 4-6 weeks. The intervention will be capped at a maximum of 10 sessions. Physical activity intervention: Participants will receive a manualised integrated physical activity intervention, embedded within routine clinical care. It will include the provision of resources and verbal and written information about the relationship between depressive symptoms and exercise; access to online resources providing advice on physical activities; and elicitation of the young person’s ideas and beliefs about this information. Clinicians randomised to this intervention will also work with the young person in creating a list of benefits and costs about physical activity and mental health to determine the young person’s readiness to change behaviour and identify motives to exercise and to increase the likelihood of exercising and maintaining changes in activity levels. Completing a weekly planner and discussing how and when the physical activity can be completed (no physical activity will be completed during sessions), and any memory aides that could be used to aid in completion of this (may include mobile technology applications (‘apps’)) will also form part of the intervention. Clinicians will work with the young person to tailor the physical activity plan each week to suit the individual’s preferences and circumstances. An electronic accelerometer device will be used to obtain objective evidence of the young person's activity levels for one week following baseline and then again for one week at the end of the intervention period.
Sponsors
Orygen, The National Centre of Excellence in Youth Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
As this is a pragmatic effectiveness trial, selection into the study will be based on ‘real-world’ characteristics of young people with depression: a) meeting the requirements for a Mental Health Treatment Plan (MHTP) to access psychological treatment under the Medicare Benefits Scheme Better Access program or Access to Allied Psychological Services (ATAPS) with likely diagnoses of major depressive disorder, rather than by a formal diagnostic research interview; and b) a score on the clinician-rated Quick Inventory of Depression Symptoms - Adolescent Version of 11 or greater, indicating depression levels of moderate or above.
Exclusion criteria
Presence of a psychotic disorder meeting diagnostic threshold during the intake assessment upon first presentation to the headspace centre; current physical activity meeting the Australian Government Guidelines (under 18 years: 60 mins/day moderate-vigorous activity; over 18 years: 30 mins moderate physical activity, most or all days); presence of an eating disorder meeting diagnostic threshold assessed during the standard intake procedure at headspace centres, using a standardised psychosocial assessment; organic mental disorder; physical illness that contra-indicates participation in physical activity; intellectual disability/cognitive impairment that precludes providing informed consent. Any young person reporting a prior history of physical illness which might impede their ability to take part in physical activity will be required to receive medical clearance from a GP in order to partake in the trial.
Outcome results
None listed