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Completed

NCT Number: NCT02850341

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Health Behavior Mental Disorders Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Paracelsus University Salzburg - Clinic for Psychiatry and Psychotherapy, Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pedometer

Device

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

Primary outcomes

  1. Change in average number of steps per day

    Time frame: 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)

  2. Change in depressive symptoms - clinician rated

    Time frame: 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 outcomes

  1. Change in physical activity - subjective

    Time frame: 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)

  2. Change in physical activity - objective

    Time frame: 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)

  3. Change in psychopathological symptoms

    Time frame: 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)

  4. Change in health-related quality of life

    Time frame: 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)

  5. Change in depressive symptoms

    Time frame: 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)

  6. Change in anxiety symptoms

    Time frame: 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)

  7. Change in self-efficacy for physical activity

    Time frame: 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)

  8. Change in intention for physical activity

    Time frame: 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)

  9. Change in self concordance of the motivation for physical activity

    Time frame: 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

  10. Change in outcome expectancies for physical activity

    Time frame: 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)

  11. Change in planning and barrier planning for physical activity

    Time frame: 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)

  12. Duration of inpatient treatment (Number of days)

    Time frame: Duration of inpatient treatment is assessed at the end of inpatient treatment

  13. Change in general self-efficacy

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Robert-Enke-Stiftung

Registry information

Official study title

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

Acronym: SAD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2016
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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