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

Not Applicable

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Physical activity promotion + TAU; Behavioral: Control

• Registration Number: NCT03403881
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-19
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07
• Primary Completion: 2018-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity promotion + TAU	Physical activity promotion + TAU	Physical activity promotion based on: * Pedometers use; * Weekly contact (telephone or face-to-face); * Contact based on a self-determination theory. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.
Control	Control	Weekly calls with general health content. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Depressive symptoms (self-reported)	At the end of the intervention (6 months)	Beck depressive inventory
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
Physical activity levels - objective measure	At the end of the intervention (6 months)	pedometer (only for intervention group)
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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil