RecruitingACTRN12614000282684

Moving 4 Mood: a trial of a physical activity intervention as an adjunct to regular care for young people with depression

A randomised controlled trial of a brief physical activity intervention in addition to standard clinical care for young people with depression


Sponsor

Orygen Youth Health Research Centre, The University of Melbourne

Enrollment

120 participants

Start Date

Oct 1, 2013

Study Type

Interventional

Conditions

Summary

This project aims to train allied health professionals working with young people with depression to integrate a brief physical activity intervention into the clinical care they would usually offer young people who access their service. The project also aims to evaluate the effectiveness of the physical activity intervention in reducing depression and increasing engagement in physical activity in young people. Physical activity has an emerging evidence base for the treatment of depression in young people. This project has the potential to provide early intervention to encourage the establishment and maintenance of positive health behaviours. All allied health professionals at headspace Collingwood (an enhanced primary care youth mental health service) 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 headspace Collingwood will be screened for eligibility to participate in a randomised controlled trial. Those who consent to take part will be randomised to receive either the physical activity intervention (active intervention) or psycho-education on physical activity (control condition) in addition to treatment as usual. Participation will involve the completion of questionnaires designed to measure symptoms, physical activity levels, social and vocational functioning, coping skills, and changes associated with therapy. These measures will be collected at baseline and at the end of treatment. Participants will also be invited to take part in an optional qualitative component of the project to obtain feedback on their experiences of treatment, using a semi-structured interview format. Given the high prevalence of depression and the associated negative consequences, there is an urgent need for a ‘real-world’ effectiveness trial to examine the additional benefits of integrating physical activity, a low-stigma intervention with few side effects, into routine clinical care


Eligibility

Sex: Both males and femalesMin Age: 12 YearssMax Age: 25 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a brief physical activity program to the usual mental health care for young people with depression helps reduce depression symptoms and increase daily exercise. Participants will be randomly assigned to either the physical activity program or general education about physical activity. The study is being run at headspace Collingwood, a youth mental health service. You may be eligible if: - You are between 12 and 25 years old - You have been referred to a youth mental health service with likely depression - You meet the criteria for a Mental Health Treatment Plan, OR you have reported significant depression symptoms in recent weeks You may NOT be eligible if: - You are currently experiencing psychotic symptoms - You already do the recommended amount of physical activity per week - You have symptoms of an eating disorder - You have an organic mental disorder or cognitive impairment - You have a physical illness that makes exercise unsafe Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants who are randomised to the physical activity intervention will receive a manualised integrated physical activity intervention, based on a behavioural activation framework, in addition to r

Participants who are randomised to the physical activity intervention will receive a manualised integrated physical activity intervention, based on a behavioural activation framework, in addition to routine clinical care (psychological therapy of the clinician’s choice). The treatment manual/pack includes: 1) provision of resources (e.g., water bottle) and verbal and written information about the relationship between depressive symptoms and physical activity; 2) elicitation of the young person's ideas and beliefs about this information; 3) creating a list of costs and benefits for engaging in physical activity for mental health; 4) mapping current levels of physical activity; 5) provision of Australian Department of Health physical activity guidelines for their age group to assist with creating physical activity goals for the next 6-10 weeks; 6) brainstorming a range of physical activities (current and activities to try), separated into three levels based on energy expenditure (light, moderate, vigorous); 7) completing incremental goals for physical activity and recording sheet to monitor the relationship between mood and activity levels; 8) completing a weekly planner and discuss memory aides that could be used (e.g., physical activity mobile technology applications/'apps'). The intervention will be delivered in up to 10 weekly (or fortnightly) sessions, of 50 minutes duration, on an individual basis, by an allied health professional. The total duration of the intervention will be up to 10 weeks for weekly sessions (or up to 20 weeks for fortnightly sessions). Participants will receive weekly or fortnightly sessions depending on participant choice and availability and/or clinical judgement. The fidelity of the physical activity intervention will be assessed by a brief allied health professional checklist following each session to measure the type of intervention and time spent delivering it in each session. Time spent on the intervention will contribute to the evaluation of its feasibility. The checklist will also assess the types and components of psychological therapies delivered as part of treatment as usual and an estimate of time spent on these. Fidelity will also be assessed by audio-taping of a random selection of treatment sessions (approximately 25% of each allied health professional’s total session numbers). Twenty-five percent of the recordings will be coded by an independent rater for adherence to the treatment manual and to discriminate between the intervention and control conditions. Fidelity of the intervention will also be assessed using a checklist of components of the active condition collected from participants at the endpoint assessment.


Locations(1)

VIC, Australia

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ACTRN12614000282684