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

February 5, 2018 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
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
PLACEBO_COMPARATOR: 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.
Behavioral: Control
Weekly call on general health aspects + treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the intervention (6 months)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Director: Marcelo B Fleck, PhD, Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

May 1, 2019

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

January 11, 2018

First Posted (ACTUAL)

January 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0532

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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