DepressionSADNCT02850341
Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression
A study testing Pedometer in people with Depression, run by Charite University, Berlin, Germany at 9 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Pedometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jul 2016to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depression, moderate to severe as main diagnosis
- Inpatient status
- Prospected inpatient treatment of at least 4 weeks
- Able to understand german
Who cannot join
- 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
Show all 12Show fewer
- Psychotic Depression
- Pregnancy
- Acute suicidality
- Substance dependancies with actual consumption (except nicotine)
- Current pedometer-use
- More than 10.000 steps per day
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic
Aachen, North Rhine-Westphalia, 52074
Charité Universitätsmedizin Berlin - Departement of Psychiatry
Berlin, 10117
Health Center Odenwaldkreis GmbH - Center for Mental Health
Erbach im Odenwald, Hesse, 64711
Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy
Flensburg, Schleswig-Holstein, 24939
University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy
Frankfurt am Main, Hesse, 60528
University of Göttingen - Clinic for Psychiatry and Psychotherapy
Göttingen, Lower Saxony, 37075
Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy
Hennigsdorf, Brandenburg, 16761
Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy
Munich, Bavaria, 80366
Austria1 site
Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy
Salzburg, 5020
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Pedometer
- Keywords
- Physical Activity, Mental Health, Health Behavior, Walking, Physical Exercise, Mental disorder
- Medical subject headings
- Depression, Motor Activity, Psychological Well-Being, Health Behavior, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedometerDevice
Patients receive a pedometer with instructions how to raise their number of daily steps
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients receive a pedometer and instructions how to raise their physical activity Receives: Device: Pedometer |
| Control group | No intervention | Patients receive treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average number of steps per day
Number of steps per day is objectively measured using accelerometry (ActiGraph GT1M)
Measured: 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
Measured: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Secondary outcomes (13)
Change in physical activity - subjective
Physical activity is subjectively measured with the International Physical Activity Questionnaire (IPAQ)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Robert-Enke-Stiftung
- Responsible party
- Principal investigator, Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
- Investigators
- Andreas Ströhle, Prof.Dr., Principal investigator, Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850341
- Sponsor's protocol ID
- SAD
- Acronym
- SAD
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2016
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02850341
- Acronym / sponsor ID
- SAD / SAD
- Conditions
- Depression
- Keywords
- Physical Activity, Mental Health, Health Behavior, Walking, Physical Exercise, Mental disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Robert-Enke-Stiftung
- Study start
- Jul 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: PedometerPatients receive a pedometer and instructions how to raise their physical activity |
| Control group | No intervention | –Patients receive treatment-as-usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major Depression, moderate to severe as main diagnosis
- Inpatient status
- Prospected inpatient treatment of at least 4 weeks
- Able to understand german
Key exclusion criteria (12 listed)
- Physical disease or disability that makes it impossible to reach the goal 5000 steps per day
- Borderline personality disorder
- Bipolar Disorder
- Schizophrenia
- Anorexia Nervosa
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PedometerPatients receive a pedometer with instructions how to raise their number of daily steps | Device | Intervention group |
Primary outcome
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)
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
13 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Duration of inpatient treatment (Number of days)
Time frame: Duration of inpatient treatment is assessed at the end of inpatient treatment
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Ströhle, Prof.Dr. principal investigator
Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer in people with Depression, run by Charite University, Berlin, Germany at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021; AzTrials last refreshed its copy on 2 Nov 2026.