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

• Conditions: depression; mood disorder; 10027946

• Registration Number: NL-OMON32780
• Lead Sponsor: Symforagroep (Amersfoort)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

age 18 -65 years
DSM-IV diagnosis: unipolar of bipolar depression
baseline score Hamilton Rating Scale of Depresion (HRSD) >= 14
treated for depressive episode

Exclusion Criteria

- patients with comorbid psychiatric disorders
- patients in longstay facilities or with complex pathology
- significant cardiovascular disease or other medical conditions which contra-indicates exercise therapy
- contraindications for walking and/or running
- addiction to alcohol and other drugs as a primary diagnosis
- high suicide risk
- regular physical exercise (2-3 times a week on a high-intensity)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is reduction in depressive symptoms as measured<br /><br>with the Hamilton Rating Scale for Depression (HRSD). It is expected that<br /><br>patients in the usual care group will respond with a mean reduction of 6 points<br /><br>compared to 8 points for the intervention group on the HRSD. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Metabolic syndrome will be evaluated by a physical test and blood samples<br /><br>including BMI, waist circumference, systolic and diastolic blood pressure,<br /><br>fasting glucose, triglycerides, cholesterol/HDL-ratio, creatinine and Cockroft<br /><br>clearance; Quality of life by the WHO-DAS questionnaire and cost effectiveness<br /><br>by the TIC-P questionnaire, the EUROQOL and a VAS for subjective health.</p><br>