Depression
Conditions
Keywords
Physical Activity, Mental Health, Health Behavior, Walking, Physical Exercise, Mental disorder
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.
Interventions
DEVICEPedometer
Patients receive a pedometer with instructions how to raise their number of daily steps
Sponsors
Robert-Enke-Stiftung
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Major Depression, moderate to severe as main diagnosis * Inpatient status * Prospected inpatient treatment of at least 4 weeks * Able to understand german
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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) |
| 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 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 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) |
| 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 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) |
| 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) |
Countries
Austria, Germany
Outcome results
None listed