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

NCT03403881 | Unknown

• 1 other identifier: 15-0532
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Physical activity - self-report

  At the end of the intervention (6 months)

• Physical activity levels - objective measure

  At the end of the intervention (6 months)

• Quality of life

  At the end of the intervention (6 months)

• Depressive symptoms (self-reported)

  At the end of the intervention (6 months)

• Melancholia

  At the end of the intervention (6 months)

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

Physical activity promotion + TAU 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

Physical activity promotion + TAU

Control BEHAVIORAL

Weekly call on general health aspects + treatment as usual

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 25439084 BACKGROUND

• 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.

  PMID: 26707338 BACKGROUND

• 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.

  PMID: 26978184 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Motor Activity; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavior; Behavioral Symptoms

Study Officials

• Marcelo B Fleck, PhD

  Researcher

  STUDY DIRECTOR

Central Study Contacts

PhD

CONTACT

Felipe Schuch, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: January 19, 2018
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

BR (1)