Personality traits as predictors of exercise treatment adherence in major depressive disorder: lessons from a randomised clinical trial.

OBJECTIVE: The objective of this study was to explore the determinants of adherence in the EFFORT-D (EFFect Of Running Therapy) study in a specialised mental health care hospital setting. METHODS: Patients with major depressive disorder (MDD) were given treatment as usual and half were randomised to an exercise intervention. Adherence was measured at 3 months (T3) and 6 months (T6) and was defined as participation in the overall study protocol (total n = 42, adhered n = 28) or intervention (total n = 24, adhered n = 9). Potential determinants were age, BMI, tobacco and alcohol use, severity of depression, anxiety, fitness (VO2max kg-1 and Wmax kg-1) and personality traits at baseline. ANOVA, Chi-square tests and block-wise logistic regression were performed, and reliability of the scales was determined. RESULTS: Numbers were found too low for analyses on smoking, drinking and anxiety. Higher agreeableness was significantly associated with better adherence to the overall study protocol (OR 1.2; p = 0.03; 95% CI: 1.01-1.4) and severity of depression was negatively associated with adherence in the intervention group (OR 0.70; p = 0.046;95% CI: 0.49-0.99). CONCLUSIONS: To adhere to a study protocol involving exercise or to a clinical exercise programme, MDD patients need substantial personal support. Measurement of personality traits and the severity of depression as potential predictors of adherence could be considered for this purpose. Keypoints Adherence to exercise and study protocols in a randomised controlled trial was low Patients with severe major depressive disorder need substantial personal support Measurement of personality traits could be considered.

EFFORT-D: results of a randomised controlled trial testing the EFFect of running therapy on depression.

Results of a randomised controlled trial testing the EFFect Of Running Therapy on Depression. BACKGROUND: This randomised controlled trial explored the anti-depressive and health effects of add-on exercise (running therapy or Nordic walking) in patients with Major Depressive Disorder (MDD). METHODS: Patients were recruited at three specialised mental health care institutions. In the intervention group exercise was planned two times a week during 6 months, the control group received care as usual. Observer-blinded measurements included Hamilton-17 depression scores and several health and fitness parameters. Submaximal bicycle-tests were performed at inclusion, 3, 6 and 12 months. The effects of exercise were assessed by effect size, intention-to-treat and analysis per protocol using General Linear Models (GLM) with time x group interactions. RESULTS: In total, 183 patients were assessed for eligibility and 135 were excluded (40% of the potential participants declined to participate mainly due to a lack of time and motivation). Together with a drop-out of 55% at 6 months, this reduced the power of the study severely. As a result, statistical analysis was performed only on the first 3 months of the study. Data were ultimately analysed from 46 patients, of which 24 were in the intervention group. Significantly more women were in the intervention group, and depression and fitness were higher in the control group. Participants showed 2-3 points less depression on average after 3 months. However, the GLM showed no effect on depression (Cohen's d < 0.2, F = .13, p = .73) in both the intention-to-treat and per protocol analyses. However, large effect sizes (Cohen's d > 0.8) were found for aerobic capacity (VO2max∙.kg- 1, F = 7.1, p = .02*), maximal external output (Wmax∙.kg- 1, F = 6.1, p = .03*), and Body Mass Index (F = 5, p = .04*), in favour of the intervention group. CONCLUSIONS: In this selective and relative small clinical population with MDD, an anti-depressive effect of the exercise intervention could not be measured and is also unlikely due to the very low effect size. An integrated lifestyle intervention will probably be more effective than a single add-on exercise intervention. However, significantly increased fitness levels may contribute to the alleviation of current cardio-metabolic risk factors or prevention of these in the future. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1894 on July 2nd 2009.

Physical activity and quality of life in long-term hospitalized patients with severe mental illness: a cross-sectional study.

BACKGROUND: Increasing physical activity in patients with severe mental illness is believed to have positive effects on physical health, psychiatric symptoms and as well quality of life. Till now, little is known about the relationship between physical activity and quality of life in long-term hospitalized patients with severe mental illness and knowledge of the determinants of behavioural change is lacking. The purpose of this study was to elucidate the relationship between objectively measured physical activity and quality of life, and explore modifiable psychological determinants of change in physical activity in long-term hospitalized patients with severe mental illness. METHODS: In 184 inpatients, physical activity was measured using an accelerometer (ActiGraph GTX+). Quality of life was assessed by EuroQol-5D and WHOQol-Bref. Attitude and perceived self-efficacy towards physical activity were collected using the Physical Activity Enjoyment Scale and the Multidimensional Self Efficacy Questionnaire, respectively. Patient and disease characteristics were derived retrospectively from electronic patient records. Associations and potential predictors were analysed using hierarchical regression. RESULTS: Physical activity was positively related with and a predictor of all quality of life outcomes except on the environmental domain, independent of patient and disease characteristics. However, non-linear relationships showed that most improvement in quality of life lies in the change from sedentary to light activity. Attitude and self-efficacy were not related to physical activity. CONCLUSIONS: Physical activity is positively associated with quality of life, especially for patients in the lower spectrum of physical activity. An association between attitude and self-efficacy and physical activity was absent. Therefore, results suggest the need of alternative, more integrated and (peer-)supported interventions to structurally improve physical activity in this inpatient population. Slight changes from sedentary behaviour to physical activity may be enough to improve quality of life.

Accelerometer-measured sedentary behaviour and physical activity of inpatients with severe mental illness.

Sedentary behaviour and lack of physical activity threatens health. Research concerning these behaviours of inpatients with severe mental illness is limited but urgently needed to reveal prevalence and magnitude. In total, 184 inpatients (men n =108, women n =76, mean age 57,4, 20% first generation antipsychotics, 40% second generation antipsychotics, 43% antidepressants, mean years hospitalisation 13 years), with severe mental illness of a Dutch psychiatric hospital wore an accelerometer for five days to objectively measure total activity counts per hour and percentages in sedentary behaviour, light intensity physical activity and moderate to vigorous physical activity. Accelerometer data were compared with data of 54 healthy ward employees. Patients showed significantly less activity counts per hour compared to employees (p=0.02), although the differences were small (d=0.32). Patients were sedentary during 84% of the wear time (50min/h), spend 10% in light intensity physical activity and 6% in moderate to vigorous physical activity. Age was the only significant predictor, predicting less total activity counts/h in higher ages. Decreasing sedentary behaviour and improving physical activity in this population should be a high priority in clinical practice.

Effect of running therapy on depression (EFFORT-D). Design of a randomised controlled trial in adult patients [ISRCTN 1894].

BACKGROUND: The societal and personal burden of depressive illness is considerable. Despite the developments in treatment strategies, the effectiveness of both medication and psychotherapy is not ideal. Physical activity, including exercise, is a relatively cheap and non-harmful lifestyle intervention which lacks the side-effects of medication and does not require the introspective ability necessary for most psychotherapies. Several cohort studies and randomised controlled trials (RCTs) have been performed to establish the effect of physical activity on prevention and remission of depressive illness. However, recent meta-analysis's of all RCTs in this area showed conflicting results. The objective of the present article is to describe the design of a RCT examining the effect of exercise on depressive patients. METHODS/DESIGN: The EFFect Of Running Therapy on Depression in adults (EFFORT-D) is a RCT, studying the effectiveness of exercise therapy (running therapy (RT) or Nordic walking (NW)) on depression in adults, in addition to usual care. The study population consists of patients with depressive disorder, Hamilton Rating Scale for Depression (HRSD) ≥ 14, recruited from specialised mental health care. The experimental group receives the exercise intervention besides treatment as usual, the control group receives treatment as usual. The intervention program is a group-based, 1 h session, two times a week for 6 months and of increasing intensity. The control group only performs low intensive non-aerobic exercises. Measurements are performed at inclusion and at 3,6 and 12 months.Primary outcome measure is reduction in depressive symptoms measured by the HRSD. Cardio-respiratory fitness is measured using a sub maximal cycling test, biometric information is gathered and blood samples are collected for metabolic parameters. Also, co-morbidity with pain, anxiety and personality traits is studied, as well as quality of life and cost-effectiveness. DISCUSSION: Exercise in depression can be used as a standalone or as an add-on intervention. In specialised mental health care, chronic forms of depression, co-morbid anxiety or physical complaints and treatment resistance are common. An add-on strategy therefore seems the best choice. This is the first high quality large trial into the effectiveness of exercise as an add-on treatment for depression in adult patients in specialised mental health care. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1894.