Skip to main content
Clinical Trials/NCT03403881
NCT03403881
Unknown
Not Applicable

Avaliação de Uma intervenção de promoção Atividade física em Pacientes Com depressão Maior em Atendimento Ambulatorial (MOVEDEP): um Ensaio clínico Randomizado

Hospital de Clinicas de Porto Alegre1 site in 1 country130 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
130
Locations
1
Primary Endpoint
Depressive symptoms (blinded assessment)
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
May 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Depressive symptoms (blinded assessment)

Time Frame: 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 Outcomes

  • Depressive symptoms (self-reported)(At the end of the intervention (6 months))
  • Quality of life(At the end of the intervention (6 months))
  • Physical activity - self-report(At the end of the intervention (6 months))
  • Physical activity levels - objective measure(At the end of the intervention (6 months))
  • Melancholia(At the end of the intervention (6 months))
  • Weight(At the end of the intervention (6 months))

Study Sites (1)

Loading locations...

Similar Trials