Movement for Depression - An RCT Assessing the Effects of Physical Activity Promotion for People With MDD

Major Depressive Disorder Clinical Trial

— MOVEDEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03403881
• Other study ID #: 15-0532
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2017
• Last updated: February 5, 2018
• Start date: March 2016
• Est. completion date: May 2019

Study information

• Verified date: February 2018
• Source: Hospital de Clinicas de Porto Alegre
• Contact: , PhD
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The contacts will be made by face-to-face interviews and telephone calls

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Physical 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
• Control
Weekly call on general health aspects + treatment as usual

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Physical activity - self-report	IPAQ	At the end of the intervention (6 months)
Secondary	Physical activity levels - objective measure	pedometer (only for intervention group)	At the end of the intervention (6 months)
Secondary	Quality of life	WHOQOL-BREF	At the end of the intervention (6 months)
Secondary	Depressive symptoms (self-reported)	Beck depressive inventory	At the end of the intervention (6 months)
Secondary	Melancholia	assessed using the CORE instrument	At the end of the intervention (6 months)
Secondary	Weight	Weight in kilograms	At the end of the intervention (6 months)