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

Study Overview
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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.

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

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Physical activity promotion + TAU
* Behavioral: Control


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physical activity promotion + TAU<br>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<br>* 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<br>|
| Placebo Comparator: Control<br>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<br>* Weekly call on general health aspects + treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical activity, Behavioral change, Depression, Major Depressive Disorder, Health promotion