Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 292
- Locations
- 9
- Primary Endpoint
- Change in depressive symptoms - clinician rated
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Prof. Dr. Andreas Ströhle
Prof. Dr. med.
Charite University, Berlin, Germany
Eligibility Criteria
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
- •Psychotic Depression
- •Pregnancy
- •Acute suicidality
- •Substance dependancies with actual consumption (except nicotine)
- •Current pedometer-use
Outcomes
Primary Outcomes
Change in depressive symptoms - clinician rated
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 rated by a blind study employee using MADRS
Change in average number of steps per day
Time Frame: 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 Outcomes
- 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))
- Change in psychopathological symptoms(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- 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))
- Duration of inpatient treatment (Number of days)(Duration of inpatient treatment is assessed at the end of inpatient treatment)
- 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))
- 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))
- Change in anxiety symptoms(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- 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))
- 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))
- 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))
- 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))
- Change in depressive symptoms(From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment))
- 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))