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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pedometer
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Physical Activity, Mental Health, Health Behavior, Walking, Physical Exercise, Mental disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy
  • Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy
  • Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy
  • Health Center Odenwaldkreis GmbH - Center for Mental Health
  • University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy
  • University of Göttingen - Clinic for Psychiatry and Psychotherapy
  • University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic
  • Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy
  • Charité Universitätsmedizin Berlin - Departement of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Patients receive a pedometer and instructions how to raise their physical activity

Patients receive treatment-as-usual

Outcomes

Primary Outcome Measures

Change in average number of steps per day
Number of steps per day is objectively measured using accelerometry (ActiGraph GT1M)
Change in depressive symptoms - clinician rated
Depressive symptoms are rated by a blind study employee using MADRS

Secondary Outcome Measures

Change in physical activity - subjective
Physical activity is subjectively measured with the International Physical Activity Questionnaire (IPAQ)
Change in physical activity - objective
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
Change in psychopathological symptoms
Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
Change in health-related quality of life
Health-related quality of life is measured using the Short-Form Health Questionnaire (SF-12)
Change in depressive symptoms
Depressive symptoms are measured using the Beck Depression Inventory (BDI II)
Change in anxiety symptoms
Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI)
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)
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)
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
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)
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)
Duration of inpatient treatment (Number of days)
Change in general self-efficacy
General self-efficacy is measured using the General-Self-Efficacy Scale (GSE)

Full Information

First Posted
July 22, 2016
Last Updated
August 27, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Robert-Enke-Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT02850341
Brief Title
Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression
Acronym
SAD
Official Title
Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Robert-Enke-Stiftung

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Physical Activity, Mental Health, Health Behavior, Walking, Physical Exercise, Mental disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patients receive a pedometer and instructions how to raise their physical activity
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receive treatment-as-usual
Intervention Type
Device
Intervention Name(s)
Pedometer
Intervention Description
Patients receive a pedometer with instructions how to raise their number of daily steps
Primary Outcome Measure Information:
Title
Change in average number of steps per day
Description
Number of steps per day is objectively measured using accelerometry (ActiGraph GT1M)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in depressive symptoms - clinician rated
Description
Depressive symptoms are rated by a blind study employee using MADRS
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Secondary Outcome Measure Information:
Title
Change in physical activity - subjective
Description
Physical activity is subjectively measured with the International Physical Activity Questionnaire (IPAQ)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in physical activity - objective
Description
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in psychopathological symptoms
Description
Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in health-related quality of life
Description
Health-related quality of life is measured using the Short-Form Health Questionnaire (SF-12)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in depressive symptoms
Description
Depressive symptoms are measured using the Beck Depression Inventory (BDI II)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in anxiety symptoms
Description
Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in self-efficacy for physical activity
Description
Self-efficacy for physical activity is measured using six likert scaled items by Scholz, U., Sniehotta, F. & Schwarzer, R. (2005)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in intention for physical activity
Description
Intention for physical activity is measured using two likert scaled items by Sniehotta, F. F., Schwarzer, R., Scholz, U., & Schüz, B. (2005)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in self concordance of the motivation for physical activity
Description
Self concordance of the Motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in outcome expectancies for physical activity
Description
Outcome expectancies for physical activity are measured using 6 likert scaled items by Lippke S., Ziegelmann, J. P. & Schwarzer, R. (2005)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Change in planning and barrier planning for physical activity
Description
Planning and barrier planning for physical activity is measured using 8 likert scaled items by Sniehotta, F. F. et al. (2005) / Renner, B. (2007)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Title
Duration of inpatient treatment (Number of days)
Time Frame
Duration of inpatient treatment is assessed at the end of inpatient treatment
Title
Change in general self-efficacy
Description
General self-efficacy is measured using the General-Self-Efficacy Scale (GSE)
Time Frame
From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 Dementia Psychotic Depression Pregnancy Acute suicidality Substance dependancies with actual consumption (except nicotine) Current pedometer-use More than 10.000 steps per day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof.Dr.
Organizational Affiliation
Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy
City
Munich
State/Province
Bayern
ZIP/Postal Code
80366
Country
Germany
Facility Name
Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy
City
Hennigsdorf
State/Province
Brandenburg
ZIP/Postal Code
16761
Country
Germany
Facility Name
Health Center Odenwaldkreis GmbH - Center for Mental Health
City
Erbach
State/Province
Hessen
ZIP/Postal Code
64711
Country
Germany
Facility Name
University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
Facility Name
University of Göttingen - Clinic for Psychiatry and Psychotherapy
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24939
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin - Departement of Psychiatry
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.angstambulanz-charite.de
Description
Related Info

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

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