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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: Pedometer

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy
• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Berlin - Departement of Psychiatry
  • Bayern
    • Munich, Bayern, Germany, 80366
      • Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy
  • Brandenburg
    • Hennigsdorf, Brandenburg, Germany, 16761
      • Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy
  • Hessen
    • Erbach, Hessen, Germany, 64711
      • Health Center Odenwaldkreis GmbH - Center for Mental Health
    • Frankfurt am Main, Hessen, Germany, 60528
      • University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy
  • Niedersachsen
    • Göttingen, Niedersachsen, Germany, 37075
      • University of Göttingen - Clinic for Psychiatry and Psychotherapy
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic
  • Schleswig-Holstein
    • Flensburg, Schleswig-Holstein, Germany, 24939
      • Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Robert-Enke-Stiftung
• Investigators: Principal Investigator: Andreas Ströhle, Prof.Dr., Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (ESTIMATE): August 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Physical Activity; Mental Health; Walking; Health Behavior; Physical Exercise; Mental disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: SAD (Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO