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

Charite University, Berlin, Germany292 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

292

Conditions

Depression

Interventions

PedometerDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (9)

Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy

Salzburg, Austria

Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy

Munich, Bavaria, Germany

Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy

Hennigsdorf, Brandenburg, Germany

Outcomes

Primary Outcomes

Change in average number of steps per day

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)

Change in depressive symptoms - clinician rated

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 Outcomes

Change in physical activity - subjective

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)

Change in physical activity - objective

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)

Change in psychopathological symptoms

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)

Change in health-related quality of life

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)

Data from ClinicalTrials.gov

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Health Center Odenwaldkreis GmbH - Center for Mental Health

Erbach im Odenwald, Hesse, Germany

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

Frankfurt am Main, Hesse, Germany

University of Göttingen - Clinic for Psychiatry and Psychotherapy

Göttingen, Lower Saxony, Germany

University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic

Aachen, North Rhine-Westphalia, Germany

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

Flensburg, Schleswig-Holstein, Germany

Charité Universitätsmedizin Berlin - Departement of Psychiatry

Berlin, Germany

Change in depressive symptoms

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)

Change in anxiety symptoms

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)

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)

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

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)

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

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

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)

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)

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

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)