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

Primary Purpose

Major Depressive Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Physical activity promotion + TAU

Control

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Exercise, Physical activity, Behavioral change, Depression, Major Depressive Disorder, Health promotion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Physical activity promotion + TAU

Control

Arm Description

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.

Weekly calls with general health content. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Physical activity - self-report

IPAQ

Physical activity levels - objective measure

pedometer (only for intervention group)

Quality of life

WHOQOL-BREF

Depressive symptoms (self-reported)

Beck depressive inventory

Melancholia

assessed using the CORE instrument

Weight

Weight in kilograms

Full Information

NCT ID

NCT03403881

First Posted

June 28, 2017

Last Updated

February 5, 2018

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT03403881

Brief Title

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

Acronym

MOVEDEP

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

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Exercise, Physical activity, Behavioral change, Depression, Major Depressive Disorder, Health promotion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical activity promotion + TAU

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Weekly calls with general health content. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.

Intervention Type

Behavioral

Intervention Name(s)

Physical activity promotion + TAU

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

Weekly call on general health aspects + treatment as usual

Primary Outcome Measure Information:

Title

Depressive symptoms (blinded assessment)

Description

Time Frame

At the end of the intervention (6 months)

Secondary Outcome Measure Information:

Title

Physical activity - self-report

Description

IPAQ

Time Frame

At the end of the intervention (6 months)

Title

Physical activity levels - objective measure

Description

pedometer (only for intervention group)

Time Frame

At the end of the intervention (6 months)

Title

Quality of life

Description

WHOQOL-BREF

Time Frame

At the end of the intervention (6 months)

Title

Depressive symptoms (self-reported)

Description

Beck depressive inventory

Time Frame

At the end of the intervention (6 months)

Title

Melancholia

Description

assessed using the CORE instrument

Time Frame

At the end of the intervention (6 months)

Title

Weight

Description

Weight in kilograms

Time Frame

At the end of the intervention (6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

PhD

First Name & Middle Initial & Last Name or Official Title & Degree

Felipe Schuch, PhD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcelo B Fleck, PhD

Organizational Affiliation

Researcher

Official's Role

Study Director

Facility Information:

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Felipe B Schuch, PhD

Phone

+55 51 99927709

felipe.schuch@ufrgs.br

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25439084

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.

Results Reference

background

PubMed Identifier

26707338

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.

Results Reference

background

PubMed Identifier

26978184

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.

Results Reference

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

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