Exercise for Depression in Young People
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Exercise as an adjunct to routine treatment may be useful for helping young people recover
      from distressing mental health problems, but they seldom get sufficient support to help them
      to exercise. The reasons for this may be that services cannot agree on the benefits of
      exercise, and the lack of reliable evidence showing the benefits of exercise in young people
      who use mental health services. Compliance with prescribed exercise is generally low, but the
      investigators think that relatively few young people will drop out of our specially designed
      programme. The investigators have found that young 'healthy' people may respond better if
      exercise is matched to their ability. The investigators are not sure if this would work with
      young people with mental health difficulties, so the investigators want to test it. The
      investigators have also found that our enabling exercise plan, with social support and
      motivational coaching, helps people with depression to take part, and not to drop out. The
      aims of our study are to see if exercise matched to their ability, with support in taking
      part, helps young people recover from distressing mental health difficulties. The
      investigators also want to ask young people how they feel about exercise as a part of their
      recovery. The investigators want to see if motivational coaching can help ongoing
      participation in exercise, and the investigators want to follow up the young people after six
      months to see if they are still doing exercise. The investigators believe that this study is
      important because it will help young people feel better about themselves, and improve their
      quality of life. This is an important national public health goal and should enable young
      people to grow into healthy adults, and maintain their health throughout adulthood. If our
      study is successful, the investigators believe that it has the potential to change the way in
      which mental health services deliver care to young people. If the investigators can help
      young people feel better about themselves, and improve their general health and well being
      through exercise, the investigators may reduce their reliance on mental health services.

      Research hypotheses A tailored exercise intervention will lead to significantly improved
      mental health outcomes and reduced exercise attrition rates in young people with depression.
    

Detailed description: 
      Aims

        1. Compare mental health outcomes in depressed young people receiving a tailored exercise
           intervention with mental health outcomes for depressed young people in a waiting list
           control group.

        2. Explore young people's experiences of exercise in the treatment of their depression.

        3. Investigate the attrition rate for the tailored exercise intervention group.

        4. Investigate longevity of changes in exercise habit with a six month follow up.

        5. Conduct an economic evaluation of the tailored exercise intervention.

      Research Questions

        1. Does an exercise intervention programme tailored to young people's exercise levels
           significantly improve mental health outcomes and exercise attritions rates in young
           people with depression?

        2. Are the changes in exercise habit and outcomes brought about by participation in the
           tailored exercise programme still evident at six months post intervention?

        3. How cost-effective is a tailored exercise intervention in young people with depression?

        4. How acceptable is a tailored exercise intervention to young people with depression?

      Design: Pragmatic Randomised Controlled Trial. An experimental arm of a tailored exercise
      intervention and a waiting list control group.

      Sample: 14-17yr olds attending Tier 2 and Tier 3 Child and Adolescent Mental Health
      outpatient services in Nottingham City and Nottinghamshire County, presenting with
      depression. For 80% power to detect a difference in mean change between the two groups of 8
      points on the Children's Depression Inventory (the primary outcome measure), and assuming
      equal standard deviations of 16 points, significance level of p<0.05 we need 126
      participants. Assuming equal attrition of 20% we will recruit 158 participants. Random
      allocation to the experimental or control arm.

      Inclusion/exclusion criteria: Presenting symptoms defined by their assigned clinician in the
      CAMHS team, as opposed to specific diagnosis. Eligible participants: those presenting with
      depression. Exclusions: Unable to participate because of injury or physical health problem
      that precludes participation, and regular exercisers as indicated by their responses to the
      SCQ.

      Intervention: Intervention consists of 12x 60 minute aerobic exercise sessions, in groups of
      10, tailored to participants' exercise levels and preferences as assessed using the Stages of
      Change for Exercise Questionnaire (SCQ). Psychosocial and motivational support throughout
      each session to facilitate ongoing participation and enduring change consisting of behaviour
      modification: goal setting, self-monitoring, social support, enhancing self-efficacy and
      shaping. A variety of lifestyle activities will be used as these are associated with improved
      compliance rates.

      Control group: Waiting list receiving usual care. The same facilitator will be used for all
      experimental interventions. Outcome primary measures: Depression, captured using the Child
      Depression Inventory (CDI) - 5 scales measuring negative mood, interpersonal difficulties,
      negative self-esteem, ineffectiveness and anhedonia, designed for 7-17 year olds, sensitive
      to changes over the proposed timescale, quick to administer and yields an aggregate score
      indicating depressive illness and clinically significant depression. We will measure the
      number of exercise sessions completed, physical fitness using maximum energy expended, health
      and social care costs using the Client Receipt of Service Inventory (CRSI), Quality of life
      using the EQ-5D and total number of incidents of self-harm and violence, treatment received
      and compliance with this, during the 12 week intervention period. Outcome measures will be
      collected at baseline, post-intervention and six months follow-up.

      Data Analysis: Two groups, described in terms of their baseline characteristics. Primary
      outcome will be the CDI post intervention. A regression model will be used to compare the two
      groups in terms of the CDI score post intervention conditional on baseline score. No other
      confounders will be adjusted for unless there's an imbalance at baseline between the two
      groups on pre-specified covariates that are considered to influence outcome. For secondary
      outcomes, similar models will be built all conditional on the relevant baseline score in
      addition to baseline CDI score. Analyses will be intention-to-treat and conducted on a
      dataset where codes for the two intervention groups are unlabeled. All estimates of effect
      sizes and numbers needed to treat will be reported with 95% confidence intervals. The
      statistical analyses will be conducted independently of the research team with assistance
      from the Clinical Trials Support Unit, University of Nottingham Medical School.

      Economic evaluation: We will collect resource use data using the CRSI. Resource use will be
      valued using published and as appropriate patient reported, unit costs. The primary measure
      for the cost effectiveness analysis will be the SPPA. Assessing health related quality of
      life using the EQ-5D will enable a cost utility analysis to be undertaken for the trial
      period. Using the information on costs and benefits an incremental economic analysis
      comparing the intervention to usual treatment will be undertaken to estimate mean
      cost-effectiveness. If one group is clearly dominant (less costly and more effective) a
      recommendation will be made. If benefits are not significantly different then a cost
      minimisation approach will be adopted to recommend the cheapest option. If non-dominance
      occurs (that is if costs are greater and the intervention is more effective or if the
      intervention is cheaper and less effective), an incremental cost-effectiveness ratio will be
      produced and a value judgement about value for money will need to be made. To test the
      robustness of results in the face or any uncertainties, and to improve the generalisability
      of results, sensitivity analysis will be conducted. In addition, uncertainty surrounding the
      cost-effectiveness of the tailored exercise intervention will be presented graphically using
      Cost-Effectiveness Acceptability Curves. Should the data be skewed then non-parametric
      bootstrap analysis using the percentile method confidence interval will be done and
      incremental net benefits estimated.

      The qualitative study: The MRC Complex intervention Framework, shows that service delivery
      often involved therapeutic elements that are difficult to define but essential, and also the
      use of qualitative methodology alongside traditional trial design to elicit barriers and
      drivers to service delivery of interventions. Therefore, we will conduct 3 focus groups of 45
      minutes, each with 6-7 participants selected from the intervention group for their diverse
      opinions, and facilitated by two service users. We will explore acceptability, pros and cons
      of the tailored approach, what worked and what was less successful. This will help explain
      why/how the intervention was effective, if this is the case, or why it failed. We will record
      the focus groups and transcribe them. Transcripts will be coded and analysed for patterns,
      themes and sub-categories, paying particular attention to outliers and rival explanations
      given by participants. We will supplement these data with one minute 'box pops' video
      recordings, of two participants per week, to further explore the young peoples' experience of
      the intervention. To ensure validity, the results will be fed back to the focus group leaders
      and other interested participants, whose interpretations will be integrated into our
      conclusions.

      Implementation Analysis: The analysis of implementation and diffusion of innovations is
      increasingly being undertaken in order to understand knowledge transfer from research to
      clinical practice in the health service. We propose to use the Steering Group to do an
      implementation analysis of the project's findings. Such an approach is in line with MRC
      guidance for developing and evaluating complex interventions. In the steering group we
      propose to elicit from members the issues relating to the uptake of the findings from the
      proposed study and the barriers we may encounter in doing this. We will ask each member of
      the group to complete a proforma eliciting a Social Network Analysis of their interactions
      with other service providers to better understand the concerns of providers not immediately
      associated with the project.
    

Intervention name(s): Intervention: Exercise and motivational interviewing
Intervention type(s): Behavioral
Intervention description(s): 12 sessions of exercise with MI
Other intervention name(s): Exercise arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: depressive disorders; exercise therapy