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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57765
Enrollment
220
Registered
2009-08-28
Start date
2010-01-13
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression mood disorder

Interventions

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 s

Sponsors

Symforagroep (Amersfoort)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: age 18 -65 years DSM-IV diagnosis: unipolar of bipolar depression baseline score Hamilton Rating Scale of Depresion (HRSD) >

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Metabolic syndrome will be evaluated by a physical test and blood samples including 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)