Clinical trial NCT02850341: Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression
Official title: Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Physical Activity
Mental Health
Health Behavior
Walking
Physical Exercise
Mental disorder
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Robert-Enke-Stiftung
First posted: 2016-08-01
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in average number of steps per day
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in depressive symptoms - clinician rated
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Secondary outcomes:
measure: Change in physical activity - subjective
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in physical activity - objective
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in psychopathological symptoms
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in health-related quality of life
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in depressive symptoms
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in anxiety symptoms
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in self-efficacy for physical activity
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in intention for physical activity
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in self concordance of the motivation for physical activity
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in outcome expectancies for physical activity
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Change in planning and barrier planning for physical activity
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
measure: Duration of inpatient treatment (Number of days)
timeFrame: Duration of inpatient treatment is assessed at the end of inpatient treatment
measure: Change in general self-efficacy
timeFrame: From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy
city: Munich
country: Germany
facility: Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy
state: Bayern
city: Hennigsdorf
country: Germany
facility: Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy
state: Brandenburg
city: Erbach
country: Germany
facility: Health Center Odenwaldkreis GmbH - Center for Mental Health
state: Hessen
city: Frankfurt am Main
country: Germany
facility: University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy
state: Hessen
city: Göttingen
country: Germany
facility: University of Göttingen - Clinic for Psychiatry and Psychotherapy
state: Niedersachsen
city: Aachen
country: Germany
facility: University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic
state: Nordrhein-Westfalen
city: Flensburg
country: Germany
facility: Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Departement of Psychiatry
Study officials:
affiliation: Charité Universitätsmedizin Berlin - Klinik für Psychiatrie und Psychotherapie
name: Andreas Ströhle, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: