Clinical trial NCT03403881: Movement for Depression - An RCT Assessing the Effects of Physical Activity Promotion for People With MDD
Official title: Avaliação de Uma intervenção de promoção Atividade física em Pacientes Com depressão Maior em Atendimento Ambulatorial (MOVEDEP): um Ensaio clínico Randomizado
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Exercise
Physical activity
Behavioral change
Depression
Major Depressive Disorder
Health promotion
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms (blinded assessment)
timeFrame: At the end of the intervention (6 months)
Secondary outcomes:
measure: Physical activity - self-report
timeFrame: At the end of the intervention (6 months)
measure: Physical activity levels - objective measure
timeFrame: At the end of the intervention (6 months)
measure: Quality of life
timeFrame: At the end of the intervention (6 months)
measure: Depressive symptoms (self-reported)
timeFrame: At the end of the intervention (6 months)
measure: Melancholia
timeFrame: At the end of the intervention (6 months)
measure: Weight
timeFrame: At the end of the intervention (6 months)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Researcher
name: Marcelo B Fleck, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.