Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression

Study Overview
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Brief Summary
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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.

Official Title
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Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial

Conditions
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Depression

Intervention / Treatment
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* Device: Pedometer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients receive a pedometer and instructions how to raise their physical activity | Device: Pedometer<br>* Patients receive a pedometer with instructions how to raise their number of daily steps<br>|
| No Intervention: Control group<br>Patients receive treatment-as-usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average number of steps per day | Number of steps per day is objectively measured using accelerometry (ActiGraph GT1M) | From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) | 
| Change in depressive symptoms - clinician rated | Depressive symptoms are rated by a blind study employee using MADRS | From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking, Physical Activity, Mental Health, Health Behavior, Physical Exercise, Mental disorder