Step away from depression—results from a multicenter randomized clinical trial with a pedometer intervention during and after inpatient treatment of depression

Evidence for the effectiveness of physical activity (PA) in the treatment of depression prevails for outpatients with mild and moderate symptom levels. For inpatient treatment of severe depression, evidence-based effectiveness exists only for structured and supervised group PA interventions. The Step Away from Depression (SAD) study investigated the effectiveness of an individual pedometer intervention (PI) combined with an activity diary added to inpatient treatment as usual (TAU). In this multicenter randomized controlled trial, 192 patients were randomized to TAU or TAU plus PI. The two primary outcomes at discharge were depression—blindly rated with the Montgomery–Åsberg Depression Rating Scale (MADRS)—and average number of daily steps measured by accelerometers. Secondary outcomes were self-rated depression and PA, anxiety, remission and response rates. Multivariate analysis of variance (MANOVA) revealed no significant difference between both groups for depression and daily steps. Mean MADRS scores at baseline were 29.5 (SD = 8.3) for PI + TAU and 28.8 (SD = 8.1) for TAU and 16.4 (SD = 10.3) and 17.2 (SD = 9.9) at discharge, respectively. Daily steps rose from 6285 (SD = 2321) for PI + TAU and 6182 (SD = 2290) for TAU to 7248 (SD = 2939) and 7325 (SD = 3357). No differences emerged between groups in secondary outcomes. For severely depressed inpatients, a PI without supervision or further psychological interventions is not effective. Monitoring, social reinforcement and motivational strategies should be incorporated in PA interventions for this population to reach effectiveness. Supplementary Information The online version contains supplementary material available at 10.1007/s00406-023-01646-2.

General self-efficacy is measured using the General-Self-Efficacy Scale (GSE)

Brief Summary
The purpose of this study is to determine if the use of pedometers can help depressive inpatients in psychiatric clinics to increase their level of physical activity.Therefore patients are given a pedometer and instructions how to raise their level of daily steps.Intervention group is compared with a control group that is receiving treatment-as-usual.
The intervention is hypothesized to increase number of daily steps and have positive effects on mood, depression and anxiety.

S4: Differences between trial centers
Differences between trial centers were calculated for: treatment length, age, number of school years, number of physical illnesses, BMI; baseline and discharge respectively: MADRS, daily steps, BDI, IPAQ Total MET, BAI.

ANOVA revealed overall significant differences (omnibus test) in
Significant post hoc differences (with Bonferroni correction) emerged in treatment length (p = .044)with the highest in Frankfurt (60.58 days, SD = 33.02)and the lowest in Erbach (28.86 days, SD = 6.04).

Daily steps at baseline between Flensburg and Erbach as well as
Frankfurt and between Erbach and Flensburg.IPAQ MET at baseline with lowest 1840.73 (SD = 1993.37) in Berlin and highest 6485.57(SD = 7729.85) in Erbach.

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Change in physical activity -subjective [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Physical activity is subjectively measured with the International Physical Activity Questionnaire (IPAQ)  Change in physical activity -objective [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Physical activity is objectively measured using accelerometry (ActiGraph GT1M) Change in psychopathological symptoms [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)  Change in health-related quality of life [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ]  Change in depressive symptoms [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Depressive symptoms are measured using the Beck Depression Inventory (BDI II)  Change in anxiety symptoms [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI)  Change in self-efficacy for physical activity [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Self-efficacy for physical activity is measured using six likert scaled items by Scholz, U., Sniehotta, F. & Schwarzer, R. (2005)  Change in intention for physical activity [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Intention for physical activity is measured using two likert scaled items by Sniehotta, F. F., Schwarzer, R., Scholz, U., & Schüz, B. (2005)  Change in self concordance of the motivation for physical activity [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Self concordance of the Motivation for physical activity is measured using the "Sport-und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items  Change in outcome expectancies for physical activity [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Outcome expectancies for physical activity are measured using 6 likert scaled items by Lippke S., Ziegelmann, J. P. & Schwarzer, R. (2005)  Change in planning and barrier planning for physical activity [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ] Planning and barrier planning for physical activity is measured using 8 likert scaled items by Sniehotta, F. F. et al. (2005) / Renner, B. (2007)  Duration of inpatient treatment (Number of days) [ Time Frame: Duration of inpatient treatment is assessed at the end of inpatient treatment ]  Change in general self-efficacy [ Time Frame: From baseline (1.-3.day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) ]

publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. Recruitment Information Recruitment Status ICMJE Completed Actual Enrollment ICMJE (submitted: August 27, 2021) 292 Original Estimated Enrollment ICMJE (submitted: July 27, 2016) 400 Actual Study Completion Date ICMJE
Physical disease or disability that makes it impossible to reach the goal 5000 steps per ICMJE Device: Pedometer Patients receive a pedometer with instructions how to raise their number of daily steps Study Arms ICMJE  Experimental: Intervention group Patients receive a pedometer and instructions how to raise their physical activity Intervention: Device: Pedometer  No Intervention: Control group Patients receive treatment-as-usual Publications * Not Provided * Includes  Prospected inpatient treatment of at least 4 weeks  Able to understand german Exclusion Criteria:  S3b:

Response and remission rates for MADRS at discharge
MVPA, Minutes of moderate and vigorous physical activity per day.IPAQ, International Physical Activity Questionnaire; MET, Metabolic Equivalent of Task; BDI-II, Beck Depression Inventory II; BAI, Beck AnxietyInventory; Symptom Checklist 27; Short Form 12 S6.