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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Physical activity promotion + TAU

Intervention Type BEHAVIORAL

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 calls with general health content.

TAU:

Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

Weekly call on general health aspects + treatment as usual

Interventions

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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

Intervention Type BEHAVIORAL

Control

Weekly call on general health aspects + treatment as usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No