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

NCT ID: NCT02850341

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group

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

Group Type EXPERIMENTAL

Pedometer

Intervention Type DEVICE

Patients receive a pedometer with instructions how to raise their number of daily steps

Control group

Patients receive treatment-as-usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pedometer

Patients receive a pedometer with instructions how to raise their number of daily steps

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Robert-Enke-Stiftung

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Dr. Andreas Ströhle

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andreas Ströhle, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy

Salzburg, , Austria

Site Status

Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy

Munich, Bavaria, Germany

Site Status

Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy

Hennigsdorf, Brandenburg, Germany

Site Status

Health Center Odenwaldkreis GmbH - Center for Mental Health

Erbach im Odenwald, Hesse, Germany

Site Status

University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy

Frankfurt am Main, Hesse, Germany

Site Status

University of Göttingen - Clinic for Psychiatry and Psychotherapy

Göttingen, Lower Saxony, Germany

Site Status

University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic

Aachen, North Rhine-Westphalia, Germany

Site Status

Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy

Flensburg, Schleswig-Holstein, Germany

Site Status

Charité Universitätsmedizin Berlin - Departement of Psychiatry

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Zero-time Exercise for Depression
NCT03811327 COMPLETED NA