ifestyle physical activity counselling for in-patients with major depressive disorder

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Major depressive disorder (MDD)

• Registration Number: ISRCTN10469580
• Lead Sponsor: Swiss National Science Foundation

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31221205 protocol (added 24/06/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36741581/ (added 07/02/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37143013/ process evaluation (added 09/05/2023) 2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37240475/ Baseline data (added 17/07/2023) 2023 Interim results article in https://doi.org/10.36950/2023.2ciss012 Baseline data (added 17/07/2023) 2022 Interim results article in https://doi.org/10.1016/j.psychsport.2022.102294 Baseline data (added 17/07/2023) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34778756/ Baseline data (added 17/07/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37409158/ Cardiorespiratory fitness and cardiovascular risk among in-patients with depression compared to healthy controls (added 17/07/2023) 2022 Other publications in https://doi.org/10.1016/j.mhpa.2022.100464 Participant experiences (added 17/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-03
• Study Completion: 2022-01-31
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

1. Aged 18-65 years
2. Major depressive disorders according to ICD-10 diagnostic criteria (F31 type II, F32 or F33)
3. 17-item Hamilton Rating Scale for Depression (HAMD17) score =17 (moderate depression)
4. Beck's Depression Inventory II (BDI-II) score =17 (borderline clinical depression)
5. Currently not meeting the American College of Sports Medicine's physical activity recommendations (International Physical Activity Questionnaire (IPAQ) <150 minutes/week of moderate-to-vigorous physical activity)
6. Read and signed written informed consent
7. Ability to read and speak German

Exclusion Criteria

1. History of bipolar disorder type I (F31 type I)
2. History of schizophrenia or schizoaffective disorder
3. Current active alcohol or drug abuse or dependence
4. Pathological electrocardiogram (ECG)
5. Any significant medical condition that contraindicates safe participation in physical activity
6. Pregnancy or breastfeeding
7. Active suicidal intent
8. Evidence of significant cardiovascular, neuromuscular or endocrine disorders limiting regular physical activity as per American College of Sports Medicine absolute contraindications to exercise

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Objective physical activity, assessed using an Actigraph accelerometer for a seven day period with a sampling epoch of 10 seconds. Time spent in moderate physical activity and vigorous physical activity will be determined based on the accelerometer counts and the ActiLife® computer software. Only days with at least 13 hours of wear time will be considered as a valid measure of daily activity. Participants will need at least five valid days, = 4 weekdays and = 1 a weekend day, for the data to be included in the data analyses. This will be assessed at the baseline (1-2 weeks after hospitalisation), 6 weeks after hospitalisation and at the follow-up (12 months after hospitalisation)<br> 2. Physical activities during which the accelerometer cannot be worn (i.e. swimming), assessed using a non-wear time sheet<br>