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

NCT02850341 | Completed

• 1 other identifier: SAD
• Study Type: interventional
• Target: 292
• Locations: 2 countries
• Sites: 9

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.

Conditions

Depression

Keywords

Physical Activity; Mental Health; Health Behavior; Walking; Physical Exercise; Mental disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Change in physical activity - subjective

  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

  From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)

• Change in psychopathological symptoms

  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

  From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)

• Change in depressive symptoms

  From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Device: Pedometer

Control group

NO INTERVENTION

Patients receive treatment-as-usual

Interventions

Pedometer DEVICE

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major Depression, moderate to severe as main diagnosis
• Inpatient status
• Prospected inpatient treatment of at least 4 weeks
• Able to understand german

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Robert-Enke-Stiftung: collaborator

Study Sites (9)

Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy

Salzburg, 5020, Austria

Location

Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy

Munich, Bavaria, 80366, Germany

Location

Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy

Hennigsdorf, Brandenburg, 16761, Germany

Location

Health Center Odenwaldkreis GmbH - Center for Mental Health

Erbach im Odenwald, Hesse, 64711, Germany

Location

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

Frankfurt am Main, Hesse, 60528, Germany

Location

University of Göttingen - Clinic for Psychiatry and Psychotherapy

Göttingen, Lower Saxony, 37075, Germany

Location

University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic

Aachen, North Rhine-Westphalia, 52074, Germany

Location

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

Flensburg, Schleswig-Holstein, 24939, Germany

Location

Charité Universitätsmedizin Berlin - Departement of Psychiatry

Berlin, 10117, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depression; Motor Activity; Psychological Well-Being; Health Behavior; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Andreas Ströhle, Prof.Dr.

  Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: August 1, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); AU (1)