Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression
- Conditions
- Depression
- Interventions
- Device: Pedometer
- Registration Number
- NCT02850341
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 292
- Major Depression, moderate to severe as main diagnosis
- Inpatient status
- Prospected inpatient treatment of at least 4 weeks
- Able to understand german
- Physical disease or disability that makes it impossible to reach the goal 5000 steps per day
- Borderline personality disorder
- Bipolar Disorder
- Schizophrenia
- Anorexia Nervosa
- Dementia
- Psychotic Depression
- Pregnancy
- Acute suicidality
- Substance dependancies with actual consumption (except nicotine)
- Current pedometer-use
- More than 10.000 steps per day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Pedometer Patients receive a pedometer and instructions how to raise their physical activity
- Primary Outcome Measures
Name Time Method Change in depressive symptoms - clinician rated From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) Depressive symptoms are rated by a blind study employee using MADRS
Change in average number of steps per day From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) Number of steps per day is objectively measured using accelerometry (ActiGraph GT1M)
- Secondary Outcome Measures
Name Time Method Change in health-related quality of life From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) Health-related quality of life is measured using the Short-Form Health Questionnaire (SF-12)
Change in psychopathological symptoms 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 self-efficacy for physical activity 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)
Duration of inpatient treatment (Number of days) Duration of inpatient treatment is assessed at the end of inpatient treatment Change in general self-efficacy From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) General self-efficacy is measured using the General-Self-Efficacy Scale (GSE)
Change in physical activity - objective 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 self concordance of the motivation for physical activity 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 anxiety symptoms 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 outcome expectancies for physical activity 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 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)
Change in physical activity - subjective 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 depressive symptoms 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 intention for physical activity 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)
Trial Locations
- Locations (9)
Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy
🇩🇪Hennigsdorf, Brandenburg, Germany
Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy
🇦🇹Salzburg, Austria
Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy
🇩🇪Munich, Bayern, Germany
Health Center Odenwaldkreis GmbH - Center for Mental Health
🇩🇪Erbach, Hessen, Germany
University of Göttingen - Clinic for Psychiatry and Psychotherapy
🇩🇪Göttingen, Niedersachsen, Germany
University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic
🇩🇪Aachen, Nordrhein-Westfalen, Germany
University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy
🇩🇪Frankfurt am Main, Hessen, Germany
Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy
🇩🇪Flensburg, Schleswig-Holstein, Germany
Charité Universitätsmedizin Berlin - Departement of Psychiatry
🇩🇪Berlin, Germany