Randomised Controlled Trial into the Effectiveness of Running Therapy in adult patients on Depression (EFFORT-D)

Depression is a common disorder in the Dutch society which has negative effects
on wellbeing and daily personal and professional functioning. The effectiveness
of the current standard treatment by means of antidepressants may be limited
because of poor compliance and poor effectiveness in many patients and has
additional disadvantages like side effects for the patients and high costs. And
although the efficacy of psychotherapy is supported by several studies, much
less is known about the effectiveness and efficiency of this treatment.
Alternative effective low-cost therapies like exercise therapy are therefore
necessary. Exercise is relatively safe, has less negative side effects and
beneficial effects on physical health. Although recent reviews and
meta-analyses suggest that exercise most likely leads to improvements in
depressive symptoms, most of these studies show poor methodological quality.
The current study therefore aims to assess the effectiveness of exercise
therapy in depressed patients in the clinical psychiatric practice, using a
methodological high-quality study design. We postulate that allocation of
depressed patients to exercise therapy will lead to reductions in depressive
symptoms on the short term as well as on the longer term. In addition, the
effects on metabolic problems and quality of life will be monitored and the
cost effectiveness will be defined.

The objective is to assess the effectiveness of exercise therapy (running
therapy or Nordic walking) on depression in adults, in addition to usual care
(primary aim) and on metabolic syndrome measures, quality of life and cost
effectiveness (secondary aim)

Randomized controlled trial (RCT).

Patients in the intervention and control group will receive usual care by their
psychiatrists or psychologists. Additionally patients in the intervention group
will be enrolled in a six months (40 sessions, twice a week) supervised, group
physical activity program (running therapy or Nordic walking).

After informed consent included patients will be measured four times in 12
months: at baseline, halfway and at the end of the intervention (after 3 and 6
months) and at follow-up (after 12 months). Data will be collected at each
measurement in one visit through interviews (depression), digital questionnaire
(depression, pain, quality of life, health care use and productivity, life
style), physical tests (length/weight, blood pressure, submaximal cycle test,
heart rate) and by blood samples (extra visit to a laboratory). For
participants in the intervention group, compliance and intensity of
running/walking will be monitored by the instructor and heart rate registration
equipment.