Major Depressive Disorder
Conditions
Keywords
Exercise, Physical activity, Behavioral change, Depression, Major Depressive Disorder, Health promotion
Brief summary
Randomized clinical trial that aims to increase physical activity levels in people with depression and to evaluate if the increase on PA levels has impact on clinical and biological measures.
Detailed description
The contacts will be made by face-to-face interviews and telephone calls
Interventions
BEHAVIORALPhysical activity promotion + TAU
Pedometer: Each patient will receive a pedometer with increasing weekly aims on number of steps during the trial. The number of steps to be achieved starts on 4.000 and increases progressively until the end of the trial. Behavioral strategy based on STD theory, and the assessment of barriers and facilitators of each patient. All patients were receiving treatment as usual
BEHAVIORALControl
Weekly call on general health aspects + treatment as usual
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age: 18 - 65 years; * diagnosis of Major Depressive Disorder (DSM-IV), assessed by a trained psychiatrist; * score 7 or more in the HAM-D; * do not present clinical comorbidities that limit or contra-indicate the practice of physical activity; * be starting depression treatment at the Programa de transtorno do humor (PROTHUM) ; * have acess to a computer and have a facebook account; * be able to read and sign the consent term.
Exclusion criteria
* present other psychiatric diagnosis such as bipolar disorder, schizophrenia or use of alcohol or other drugs; * be not liberated to the practice of physical exercises by the assistant psychiatrist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms (blinded assessment) | At the end of the intervention (6 months) | Hamilton scale for depressive symptoms assessed by a blinded psychiatrist. Clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher scores means higher depressive symptoms. The cutoffs are the following: following severity ranges for the HAMD: no depression (0-7); mild depression (8-16); moderate depression (17-23); and severe depression (≥24). The maximum score is 52. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity levels - objective measure | At the end of the intervention (6 months) | pedometer (only for intervention group) |
| Quality of life | At the end of the intervention (6 months) | WHOQOL-BREF |
| Physical activity - self-report | At the end of the intervention (6 months) | IPAQ |
| Melancholia | At the end of the intervention (6 months) | assessed using the CORE instrument |
| Weight | At the end of the intervention (6 months) | Weight in kilograms |
| Depressive symptoms (self-reported) | At the end of the intervention (6 months) | Beck depressive inventory |
Countries
Brazil
Contacts
Primary ContactPhD
Backup ContactFelipe Schuch, PhD
Outcome results
None listed