The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial

Abstract

Background Major depressive disorder (MDD) is a widespread and burdensome psychiatric issue. Physical activity counselling may increase lifestyle physical activity and cardiorespiratory fitness in this specific and particularly vulnerable population, which often suffers from both mental and physical health problems. Therefore, this study will examine the impact of a lifestyle physical activity counselling intervention on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers among in-patients diagnosed with MDD compared to controls. Secondary purposes are to examine the acceptability and perceived usefulness of the intervention among these patients, to find out whether the effectiveness of the intervention is moderated by genetic factors, and to compare baseline values with an age- and gender-matched group of healthy controls. Methods The study is designed as a multi-centric two-arm randomized clinical trial including an intervention group and a placebo control group, allocation concealment, single-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 programme, which was specifically designed for an in-patient rehabilitation setting. The placebo control condition consists of general instructions about health-enhancing physical activity. Data assessments will take place 2–3 weeks after admission to in-patient treatment (baseline), and 6 weeks (post) and 12 months (follow-up) after discharge from in-patient treatment. The primary outcome is objectively assessed physical activity at follow-up. Discussion Because regular physical activity has proven 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. Improving physical activity may have important implications for tackling metabolic and cardiovascular disease and increasing mood and cognitive functioning in this at-risk population, hence limiting the future burden of multiple chronic conditions. Increased physical activity may also reduce the likelihood of future depressive episodes. By moving towards the primary prevention of chronic physical conditions, much can be done to enhance the quality and quantity of life of people with MDD. Trial registration ISRCTN, ISRCTN10469580 . Registered on 3 September 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3468-3) contains supplementary material, which is available to authorized users.

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“…This is a cross-sectional analysis conducted within the PACINPAT randomized controlled trial (Physical Activity Counseling in In-Patients with Major Depression) taking place in four centers in three Swiss cantons (Basel, Solothurn, and Bern) (Gerber et al, 2019). Recruitment started in January 2019, paused from March to April 2020 because of a COVID-19-induced lockdown and was taken up again in May 2020 at half the rate (January 2019-February 2020, N = 143, M = 10 participants per month vs. March 2020-December 2020, N = 52, M = 5 participants per month).…”

“…All procedures received ethical approval from the "Ethikkommission Nordwest-und Zentralschweiz" and the "Ethikkommission Bern" (approval number: 2018-00976). Additionally the PACINPAT trial is registered in the ISRCTN registry (ISRCTN10469580) and the study protocol is published for more details (Gerber et al, 2019). All procedures are in line with the guidelines for Good Clinical Practice (ICH GCP) and with the ethical standards defined in the Declaration of Helsinki.…”

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