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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT02850341

Collaborator

Robert-Enke-Stiftung (Other)

292

Enrollment

Locations

Arms

Actual Duration (Months)

32.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Device: Pedometer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

292 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Step Away From Depression - Evaluation of a Pedometer Intervention With Inpatients With Major Depression - A Randomized Controlled Trial

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Patients receive a pedometer and instructions how to raise their physical activity	Device: Pedometer Patients receive a pedometer with instructions how to raise their number of daily steps
No Intervention: Control group Patients receive treatment-as-usual

Arm

Intervention/Treatment

Experimental: Intervention group

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

Device: Pedometer

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

No Intervention: Control group

Patients receive treatment-as-usual

Outcome Measures

Primary Outcome Measures

Change in average number of steps per day [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 [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

Secondary Outcome Measures

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)]
Physical activity is subjectively measured with the International Physical Activity Questionnaire (IPAQ)
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)]
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
Change in psychopathological symptoms [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
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)]
Health-related quality of life is measured using the Short-Form Health Questionnaire (SF-12)
Change in depressive symptoms [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Depressive symptoms are measured using the Beck Depression Inventory (BDI II)
Change in anxiety symptoms [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI)
Change in self-efficacy for physical activity [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Self-efficacy for physical activity is measured using six likert scaled items by Scholz, U., Sniehotta, F. & Schwarzer, R. (2005)
Change in intention for physical activity [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Intention for physical activity is measured using two likert scaled items by Sniehotta, F. F., Schwarzer, R., Scholz, U., & Schüz, B. (2005)
Change in self concordance of the motivation for physical activity [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Self concordance of the Motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items
Change in outcome expectancies for physical activity [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Outcome expectancies for physical activity are measured using 6 likert scaled items by Lippke S., Ziegelmann, J. P. & Schwarzer, R. (2005)
Change in planning and barrier planning for physical activity [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
Planning and barrier planning for physical activity is measured using 8 likert scaled items by Sniehotta, F. F. et al. (2005) / Renner, B. (2007)
Duration of inpatient treatment (Number of days) [Duration of inpatient treatment is assessed at the end of inpatient treatment]
Change in general self-efficacy [From baseline (1.-3. day of inpatient treatment) to end of inpatient treatment (3 days before end of inpatient treatment)]
General self-efficacy is measured using the General-Self-Efficacy Scale (GSE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy	Salzburg		Austria	5020
2	Ludwig Maximilian University Munich - Clinic for Psychiatry and Psychotherapy	Munich	Bayern	Germany	80366
3	Oberhavel Clinics GmbH - Clinic for Psychiatry, Psychosomatics and Psychotherapy	Hennigsdorf	Brandenburg	Germany	16761
4	Health Center Odenwaldkreis GmbH - Center for Mental Health	Erbach	Hessen	Germany	64711
5	University of Frankfurt/Main - Clinic for Psychiatry, Psychosomatic and Psychotherapy	Frankfurt am Main	Hessen	Germany	60528
6	University of Göttingen - Clinic for Psychiatry and Psychotherapy	Göttingen	Niedersachsen	Germany	37075
7	University RWTH Aachen, Clinic for Psychiatriy, Psychotherapy and Psychosomatic	Aachen	Nordrhein-Westfalen	Germany	52074
8	Ev.Luth. Diakonissenanstalt Flensburg - Clinic for Psychiatry, Psychosomatic and Psychotherapy	Flensburg	Schleswig-Holstein	Germany	24939
9	Charité Universitätsmedizin Berlin - Departement of Psychiatry	Berlin		Germany	10117