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

PROJECT DESCRIPTION:
Depression is a common disorder in 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, cardio-pulmonary fitness, muscle-strength, pain, anxiety, quality of life, brain-derived neurotrophic factor (BDNF), and the relation with personality traits will be monitored, and the cost effectiveness will be defined.
PERIOD:
January 2010 – September 2012
FUNDING:
B@W (TNO-VUMC), Stichting “De Open Ankh”, Symfora GGZ Hospitals
INVESTIGATORS:
Ms. M. Hopman-Rock, PhD, Msc,MA,Professor, TNO and Body@Work1,2
Ms. I.J.M. Hendriksen, PhD, TNO and Body@Work1,2
Mr. F.R. Kruisdijk, MD, psychiatrist, Symfora group3
Mr. E.Tak, MSc, TNO and Body@Work1,2
Mr. R. Emons, MSc, Symfora Group3
Mr. A.J.T. Beekman, PhD, Professor, Division Psychiatry, VUMC4
1 TNO Quality of Life, Department of Health Promotion, Leiden, The Netherlands,
Department of Public and Occupational Health, VU University Medical Center part of The EMGO Institute for Health and Care Research (EMGO+) .
2 Body@Work, Research Center on Physical Activity, Work and Health, TNO-VU University Medical Centre, Amsterdam, The Netherlands
2 Body@Work, Research Center on Physical Activity, Work and Health, TNO-VU University Medical Centre, Amsterdam, The Netherlands
3 Symfora GGZ Hospitals, Amersfoort, The Netherlands
4 VU Medical Centre, Amsterdam, The Netherlands
OBJECTIVES:
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 problems, cardio-pulmonary fitness, muscle-strength, pain, anxiety, quality of life, brain-derived neurotrophic factor (BDNF), and the relation with personality traits will be monitored, and the cost effectiveness (secondary aim).
METHODS:
Randomized controlled trial (RCT). Adult patients diagnosed with a depression/bipolar disorder, who are treated or will be treated at one of the three participating (outpatient) clinics of the Symfora group, will be invited to participate. Included patients will be randomized in two groups: a control group which receives the usual care (f.e. antidepressive medication, psychotherapy (cognitive therapy or interpersonal therapy), or mentalisation based therapy) and lifestyle advice (including the advice to be physically active, in accordance with the ‘Multidisciplinaire richtlijn Depressie’, 2005). The intervention group receives six months (40 sessions, at least once a week) of supervised group exercise therapy (running therapy or Nordic walking) in addition to usual care. They are advised to join the running group and will only be referred to the Nordic walking therapy in case of clear medical contra-indications against running therapy (such as muscular-skeleton problems), or if patients have a strong personal dislike for running, which prevents participation and/or compliance.
The primary outcome measure is reduction in depressive symptoms as measured with the Hamilton Rating Scale for Depression (HRSD). Data will be collected at baseline, halfway and at the end of the intervention (after 3 and 6 months) and at follow-up (after 12 months), using interviews (depression).a digital questionnaire (various secondary parameters), physical tests and by blood samples (visit to a laboratory, only at baseline and after 6 months). For participants in the intervention group, compliance and intensity of running/walking will be monitored by the instructor and heart rate registration equipment.
RESULTS:
First results are expected medio 2012
PUBLICATIONS:
In progress
F.R. Kruisdijk, MD, psychiatrist
More information:
Ms. I.J.M. Hendriksen, PhD, F.R.Kruisdijk, MD
e-mail: frkru@symfora.nl
e-mail: frkru@symfora.nl
tel: 0031620545863 / ingrid.hendriksen@tno.nl
