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Lifestyle physical activity counselling in in-patients with major depressive disorders (PACINPAT): Randomized controlled trial on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers

Research Project
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01.06.2018
 - 31.01.2022

Major depressive disorder (MDD) is an extremely wide-spread and burdensome condition. MDD is associated with the second greatest number of life years lost due to premature death or disability (DALY) and will most likely be the leading cause in 2030. Physical activity counselling may increase lifestyle physical activity and cardiorespiratory fitness in a particularly vulnerable population which often suffers from a mix of mental and physical health problems.Goal and specific objectives: This study will examine the effectiveness of lifestyle physical activity counselling intervention among in-patients diagnosed with MDD compared to (placebo) controls. Secondary purposes are to examine the acceptability and perceived usefulness of the intervention among the patients, to compare baseline values with an age- and gender-matched group of healthy controls, and to find out whether the effectiveness of the intervention is moderated by genetic factors.Methods: The study is designed as a multi-centric two-arm randomized clinical trial including an intervention and placebo control group, allocation concealment, double-blinding, and intention-to-treat analysis. Participants (N=334) will be continuously recruited from four clinics specialized in the treatment of MDD. The intervention builds on a standardized, theory-based, low cost lifestyle physical activity counselling program, which was specifically designed for an in-patient rehabilitation setting. The placebo control condition consists of general instructions about health-enhancing physical activity. Data assessment will take place 2-3 weeks after admission to in-patient treatment (baseline), six weeks (post) and 12 months (follow-up) after discharge from in-patient treatment. Primary outcome is objectively assessed physical activity at follow-up. Secondary outcomes are self-reported physical activity, cardiorespireatory fitness, autonomic function, cognitive and social determinants of exercise, depression severity, self-perceived physical and psychological health, insomnia symtpoms, cognitive function, cardiovascular health risk markers (blood pressure, heart rate variability, BMI, percentage body fat, total/LDL/HDL cholesterol, triglycerides, HbA1c), and biomarkers of MDD (cortisol awakening response, brain-derived neurotrophic factor, tumor necrosis factor-alpha, and insulin-like growth factor). Moreover, the serotonin transporter (5-HTT) polymorphic promoter region (5-HTTLPR) will be assessed as a potential moderator of intervention effects.Expected results: Because regular physical activity has proved to be an important predictor of long-term response and remission in patients with major depression, we believe that our planned study may lay important groundwork by showing how individually-tailored lifestyle physical activity counselling can be integrated into given clinical structures. Our primary hypothesis is that compared to treatment as usual, individually-tailored physical activity counselling in patients with MDD will lead to clinically relevant increases in physical activity and CRF, and that these outcomes will persist beyond clinical discharge. The planned study is innovative for several reasons. For instance, we will test for the first time the potential of individually-tailored physical activity counselling in psychiatric in-patients, (b) focus on patients with low physical activity levels, and (c) assess physical activity objectively via accelerometry. Significance and feasibility: Improving physical activity and cardiorespiratory fitness may have important implications for tackling metabolic and cardiovascular disease and increasing cognitive functioning in this at-risk population, hence, reducing the future burden of multiple chronic conditions. Increased physical activity and cardiorespiratory fitness may also reduce the likelihood of future depressive episodes. By moving toward the primary prevention of chronic physical conditions, much can be done to enhance the quality and quantity of life of people with MDD. These findings will strengthen the evidence for "exercise as medicine" as a holistic care option in routine clinical practice for people with MDD, by helping patients to adopt and maintain physically active lifestyles after the end of their hospital stay. The study can show feasible ways to achieve long-term behaviour change by integrating lifestyle physical activity counselling into given clinical structures. Moreover, the study will show whether such an approach is acceptable for in-patients treated for MDD, and how much financial resources are needed to implement lifestyle physical activity counselling.

Funding

Lifestyle physical activity counselling in in-patients with major depressive disorders (PACINPAT): Randomized controlled trial on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers

SNF Schweizerischer Nationalfonds, 06.2018-01.2022 (44)
PI : Gerber, Markus.

Members (4)

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Markus Gerber

Principal Investigator
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Serge Brand

Co-Investigator
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Oliver Faude

Co-Investigator
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Undine Lang

Co-Investigator