Effectiveness of Running Therapy on Depression.

Rationale:
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.

Objective:
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).

Study design:
Randomized controlled trial (RCT).

Study population:
Adult patients diagnosed with a depression/bipolar disorder who are treated or will be treated at one of the three participating (outpatient) clinics.

Intervention:
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).

Main study parameters/endpoints:
The primary outcome measure is reduction in depressive symptoms as measured with the Hamilton Rating Scale for Depression (HRSD). It is expected that patients in the usual care group will respond with a mean reduction of 6 points compared to 8 points for the intervention group on the HRSD.

Secondary study parameters/endpoints:
Metabolic syndrome will be evaluated by a physical test and blood samples including Body Mass Index (BMI), waist circumference, systolic and diastolic blood pressure, fasting glucose, triglycerides, cholesterol/HDL-ratio, creatinine and Cockroft clearance; Quality of life by the WHO-DAS questionnaire and cost effectiveness by the TIC-P questionnaire, the EUROQOL and a VAS for subjective health.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.

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 (antidepressants) may be limited because of poor compliance and poor effectiveness in many patients. 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 has 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.

1. Baseline (T0);

2. Halfway the six month intervention period (T3);

3. At the end of the six months intervention period (T6);

4. At follow up, 12 months after baseline (T12).

Besides usual care, patients in the intervention group will be enrolled in a six months supervised, group physical activity program (running therapy or Nordic walking). In total 40 sessions (twice a week) are to be followed within this six months period.


Patients in the control group will receive usual care by their psychiatrists or psychologists. This may include treatment modalities such as cognitive behavioural therapy, interpersonal therapy or mentalisation based therapy and/or the use of antidepressants. In accordance with the ‘Multidisciplinaire richtlijn Depressie’ (2005) patients are advised to be physically active.