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

Depression Clinical Trial

— SAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850341
• Other study ID #: SAD
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2020

Study information

• Verified date: August 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Pedometer
Patients receive a pedometer with instructions how to raise their number of daily steps

Locations

Country	Name	City	State
Austria	Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy	Salzburg
Germany	University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic	Aachen	Nordrhein-Westfalen
Germany	Charité Universitätsmedizin Berlin - Departement of Psychiatry	Berlin
Germany	Health Center Odenwaldkreis GmbH - Center for Mental Health	Erbach	Hessen
Germany	Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy	Flensburg	Schleswig-Holstein
Germany	University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy	Frankfurt am Main	Hessen
Germany	University of Göttingen - Clinic for Psychiatry and Psychotherapy	Göttingen	Niedersachsen
Germany	Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy	Hennigsdorf	Brandenburg
Germany	Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy	Munich	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Robert-Enke-Stiftung

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Duration of inpatient treatment (Number of days)		Duration of inpatient treatment is assessed at the end of inpatient treatment
Secondary	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)

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