Exercise Enhances: A randomized controlled trial on aerobic exercise as depression treatment augmentation strategy

While there are many effective treatment options for depression, only appr. 60% of depressed patients respond sufficiently to treatment (DeRubeis et al., 2005; Dimidjian et al., 2006) and relapse rates are high (e.g. Hardeveld et al., 2010). Exercise is effective as monotherapy for depression, with comparable effects to psychological treatment and antidepressant medication in outpatient and community‐based populations, but also in inpatients (Cooney et al, 2013; Rimer et al, 2012; Stanton et al, 2014; Stathopoulou et al, 2006). It is also effective in preventing relapse (Babyak et al, 2000). Unlike most other treatment options, exercise is inexpensive, universally accessible, and without side effects (Wright & Cattan, 2009). Exercise treatment also augments the effectiveness of psychological and pharmacological treatment (e.g. Abdollahi et al, 2017; Blumenthal et al, 1999; 2007; Garry et al, 2010; Trivedi et al, 2011; Veale et al, 1992), making it an attractive adjunct treatment. Hence, exercise is a strong treatment augmentation strategy that is currently being implemented in few but some Dutch mental health care organizations. However, although a prescription for exercise treatment has been formatted (see: National Institute for Health and Clinical Excellence, NICE, 2009; Rethorst & Trivedi, 2013), this is currently not used in depression care. Moreover, the mechanisms of change are not well understood so far, requiring further research to successfully implement exercise as an augmenting treatment for depression.
The present study tries to fill this gap in the literature and investigates the augmenting effect of exercise provided alongside care as usual (CAU) for depression for 12 weeks. Moreover, we aim to examine mechanisms of change.The primary research question is: Is CAU with adjunct evidence-based prescription of exercise more effective than CAU alone in reducing depressive symptoms in patients with major depressive disorder in the specialised mental health service setting?

We expect that CAU with adjunct evidence-based prescription of exercise is more effective than CAU alone in reducing depressive symptoms in patients with major depressive disorder.

Assessments take place at baseline (T0), after session 3, 6, and 9, and at 3, 6, 9, 12, and 15-months follow-up (T1-T8)

The intervention condition receives CAU combined with physical exercise according to prescription: 12 weeks with one supervised and two at-home moderate-intensity sessions. The supervised weekly exercise sessions consist of 45 min of moderate intensity aerobic exercise. Heart rate will be measured using a heart rate monitor (FitBit). The local psychomotor therapist (mostly one per location) supervises the exercise sessions and provides coaching.
Care as usual is guideline concordant psychological and pharmacological treatment of depression in the specialised outpatient mental healthcare services. CAU will be conform the ‘Multidisciplinaire richtlijn Depressie’ (2013), which is integrated in the recently published ‘Zorgstandaard Depressieve Stoornissen’ (Akwa GGZ, 2018), see https://www.ggzstandaarden.nl/zorgstandaarden/depressieve-stoornissen.