TY - JOUR
T1 - 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
T2 - study protocol for a randomized controlled trial
AU - Gerber, Markus
AU - Beck, Johannes
AU - Brand, Serge
AU - Cody, Robyn
AU - Donath, Lars
AU - Eckert, Anne
AU - Faude, Oliver
AU - Fischer, Xenia
AU - Hatzinger, Martin
AU - Holsboer-Trachsler, Edith
AU - Imboden, Christian
AU - Lang, Undine
AU - Mans, Sarah
AU - Mikoteit, Thorsten
AU - Oswald, Anja
AU - Pühse, Uwe
AU - Rey, Sofia
AU - Schreiner, Ann-Katrin
AU - Schweinfurth, Nina
AU - Spitzer, Ursula
AU - Zahner, Lukas
PY - 2019/6/20
Y1 - 2019/6/20
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - Cardiorespiratory Fitness
KW - Cardiovascular Diseases/etiology
KW - Counseling
KW - Depressive Disorder, Major/physiopathology
KW - Exercise
KW - Humans
KW - Life Style
KW - Middle Aged
KW - Outcome Assessment, Health Care
KW - Randomized Controlled Trials as Topic
KW - Risk
KW - Single-Blind Method
KW - Young Adult
UR - https://www.mendeley.com/catalogue/27b3d0e0-0eeb-3002-a721-b02e3c7d5fc2/
U2 - 10.1186/s13063-019-3468-3
DO - 10.1186/s13063-019-3468-3
M3 - Journal articles
C2 - 31221205
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
IS - 1
M1 - 367
ER -