Major Depressive DisorderMOVEDEPNCT03403881
Movement for Depression - An RCT Assessing the Effects of Physical Activity Promotion for People With MDD
A study testing Physical activity promotion + TAU in people with Major Depressive Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Physical activity promotion + TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
PhD contact
Felipe Schuch, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Felipe B Schuch, PhD, +55 51 99927709, felipe.schuch@ufrgs.br
About this study
Official title: 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.
Read the detailed description
The contacts will be made by face-to-face interviews and telephone calls
- Conditions
- Major Depressive Disorder
- Being tested
- Physical activity promotion + TAU, Control
- Keywords
- Exercise, Physical activity, Behavioral change, Depression, Major Depressive Disorder, Health promotion
- Medical subject headings
- Depressive Disorder, Major, Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity promotion + TAUBehavioural
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
ControlBehavioural
Weekly call on general health aspects + treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Physical activity promotion + TAU | Active comparator | 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. Receives: Behavioral: Physical activity promotion + TAU |
| Control | Placebo comparator | Weekly calls with general health content.
TAU:
Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the intervention (6 months)
Secondary outcomes (6)
Physical activity - self-report
IPAQ
Measured: At the end of the intervention (6 months)
Physical activity levels - objective measure
pedometer (only for intervention group)
Measured: At the end of the intervention (6 months)
Quality of life
WHOQOL-BREF
Measured: At the end of the intervention (6 months)
Depressive symptoms (self-reported)
Beck depressive inventory
Measured: At the end of the intervention (6 months)
Melancholia
assessed using the CORE instrument
Measured: At the end of the intervention (6 months)
Weight
Weight in kilograms
Measured: At the end of the intervention (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo B Fleck, PhD, Study director, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403881
- Sponsor's protocol ID
- 15-0532
- Acronym
- MOVEDEP
- Status last verified
- Feb 2018
- First submitted
- 28 Jun 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25439084Stubbs 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.
PubMed 26707338Schuch 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.
PubMed 26978184
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação de Uma intervenção de promoção Atividade física em Pacientes Com depressão Maior em Atendimento Ambulatorial (MOVEDEP): um Ensaio clínico Randomizado
- ClinicalTrials.gov ID
- NCT03403881
- Acronym / sponsor ID
- MOVEDEP / 15-0532
- Conditions
- Major Depressive Disorder
- Keywords
- Exercise, Physical activity, Behavioral change, Depression, Major Depressive Disorder, Health promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity promotion + TAU | Active comparator | Behavioral: Physical activity promotion + TAUPhysical 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 | Placebo comparator | Behavioral: ControlWeekly calls with general health content. TAU: Treatment as usual, which include medications. Medications were prescribed by psychiatrists not involved in the study participation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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) ;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity promotion + TAUPedometer: 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 | Behavioural | Physical activity promotion + TAU |
| ControlWeekly call on general health aspects + treatment as usual | Behavioural | Control |
Primary outcome
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.
6 secondary outcomes
Physical activity - self-report
Time frame: At the end of the intervention (6 months)
Physical activity levels - objective measure
Time frame: At the end of the intervention (6 months)
Quality of life
Time frame: At the end of the intervention (6 months)
Depressive symptoms (self-reported)
Time frame: At the end of the intervention (6 months)
Melancholia
Time frame: At the end of the intervention (6 months)
Weight
Time frame: At the end of the intervention (6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Background: PubMed 25439084Schuch 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.
- Background: PubMed 26707338Stubbs 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.
- Background: PubMed 26978184Schuch 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PhD contact
Felipe Schuch, PhD contact
Marcelo B Fleck, PhD study director
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity promotion + TAU in people with Major Depressive Disorder, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PhD, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (blinded assessment) (time frame: At the end of the intervention (6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403881, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.