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

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ClinicalTrials.gov Identifier: NCT02850341
Recruitment Status : Recruiting
First Posted : August 1, 2016
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Ströhle, 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.

Condition or disease Intervention/treatment Phase
Depression Device: Pedometer Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Patients receive a pedometer and instructions how to raise their physical activity
Device: Pedometer
Patients receive a pedometer with instructions how to raise their number of daily steps

No Intervention: Control group
Patients receive treatment-as-usual



Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. Change in physical activity - subjective [ Time Frame: 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)

  2. Change in physical activity - objective [ Time Frame: 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)

  3. Change in psychopathological symptoms [ Time Frame: 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)

  4. Change in health-related quality of life [ Time Frame: 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)

  5. Change in depressive symptoms [ 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 measured using the Beck Depression Inventory (BDI II)

  6. Change in anxiety symptoms [ Time Frame: 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)

  7. Change in self-efficacy for physical activity [ Time Frame: 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)

  8. Change in intention for physical activity [ Time Frame: 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)

  9. Change in self concordance of the motivation for physical activity [ Time Frame: 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

  10. Change in outcome expectancies for physical activity [ Time Frame: 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)

  11. Change in planning and barrier planning for physical activity [ Time Frame: 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)

  12. Duration of inpatient treatment (Number of days) [ Time Frame: Duration of inpatient treatment is assessed at the end of inpatient treatment ]
  13. Change in general self-efficacy [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Dementia
  • Psychotic Depression
  • Pregnancy
  • Acute suicidality
  • Substance dependancies with actual consumption (except nicotine)
  • Current pedometer-use
  • More than 10.000 steps per day

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850341


Contacts
Contact: Andreas Ströhle, Prof.Dr. 030450517217 andreas.stroehle@charite.de
Contact: Moritz B Petzold, Dipl.Psych. 030450517217 moritz.petzold@charite.de

Locations
Austria
Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy Not yet recruiting
Salzburg, Austria, 5020
Contact: Alexander Schorb, Dr.         
Principal Investigator: Alexander Schorb, Dr.         
Germany
Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy Recruiting
Munich, Bayern, Germany, 80366
Contact: Berend Malchow, Dr.         
Contact: Astrid Röh         
Principal Investigator: Berend Malchow, Dr.         
University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy Not yet recruiting
Frankfurt am Main, Hessen, Germany, 60528
Contact: Viola Oertel-Knöchel, Dr.         
Principal Investigator: Viola Oertel-Knöchel, Dr.         
University of Göttingen - Clinic for Psychiatry and Psychotherapy Not yet recruiting
Göttingen, Niedersachsen, Germany, 37075
Contact: Dirk Wedekind, Dr.         
Principal Investigator: Dirk Wedekind, Dr.         
University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic Not yet recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Contact: Frank Schneider, Prof.Dr.Dr.         
Contact: Karsten Henkel, Dr.         
Principal Investigator: Frank Schneider, Prof.Dr.Dr.         
Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy Recruiting
Flensburg, Schleswig-Holstein, Germany, 24939
Contact: Frank Helmig, Dr.         
Principal Investigator: Frank Helmig, Dr.         
Charité Universitätsmedizin Berlin - Departement of Psychiatry Recruiting
Berlin, Germany, 10117
Contact: Andreas Ströhle, Prof.Dr.    030450517217    andreas.stroehle@charite.de   
Ev. Hostpital Alsterdorf - Clinic for Psychiatry and Psychotherapy Recruiting
Hamburg, Germany, 22337
Contact: Freya Sandmann         
Principal Investigator: Catrin Mautner, Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Ströhle, Prof.Dr. Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie

Additional Information:
Responsible Party: Prof. Dr. Andreas Ströhle, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02850341     History of Changes
Other Study ID Numbers: SAD
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany:
Physical Activity
Mental Health
Health Behavior
Walking
Physical Exercise
Mental disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders