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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.
The contacts will be made by face-to-face interviews and telephone calls
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity promotion + TAU | Active Comparator | Physical activity promotion based on:
TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation. |
|
| Control | Placebo Comparator | Weekly calls with general health content. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity promotion + TAU | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms (blinded assessment) | 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. | At the end of the intervention (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity - self-report | IPAQ | At the end of the intervention (6 months) |
| Physical activity levels - objective measure | pedometer (only for intervention group) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PhD | Contact | |||
| Felipe Schuch, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Marcelo B Fleck, PhD | Researcher | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25439084 | Background | Schuch FB, Vasconcelos-Moreno MP, Borowsky C, Zimmermann AB, Rocha NS, Fleck MP. Exercise and severe major depression: effect on symptom severity and quality of life at discharge in an inpatient cohort. J Psychiatr Res. 2015 Feb;61:25-32. doi: 10.1016/j.jpsychires.2014.11.005. Epub 2014 Nov 21. | |
| 26707338 | Background |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D009043 | Motor Activity |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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|
| Control | Behavioral | Weekly call on general health aspects + treatment as usual |
|
| At the end of the intervention (6 months) |
| Quality of life | WHOQOL-BREF | At the end of the intervention (6 months) |
| Depressive symptoms (self-reported) | Beck depressive inventory | At the end of the intervention (6 months) |
| Melancholia | assessed using the CORE instrument | At the end of the intervention (6 months) |
| Weight | Weight in kilograms | At the end of the intervention (6 months) |
| Stubbs B, Vancampfort D, Rosenbaum S, Ward PB, Richards J, Ussher M, Schuch FB. Challenges Establishing the Efficacy of Exercise as an Antidepressant Treatment: A Systematic Review and Meta-Analysis of Control Group Responses in Exercise Randomised Controlled Trials. Sports Med. 2016 May;46(5):699-713. doi: 10.1007/s40279-015-0441-5. |
| 26978184 | Background | Schuch FB, Vancampfort D, Richards J, Rosenbaum S, Ward PB, Stubbs B. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. J Psychiatr Res. 2016 Jun;77:42-51. doi: 10.1016/j.jpsychires.2016.02.023. Epub 2016 Mar 4. |
| D001526 |
| Behavioral Symptoms |