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Treating Depression With Physical Exercise

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573130
First Posted: April 6, 2012
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
  Purpose
The purpose of the study is to investigate the effects of an internet-administered, therapist-assisted physical exercise program for the treatment of depression.

Condition Intervention
Depression Behavioral: Physical exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Internet-administered, Therapist-supported Physical Exercise Program for the Treatment of Depression

Resource links provided by NLM:


Further study details as provided by Per Carlbring, PhD, Umeå University:

Primary Outcome Measures:
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 1 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 2 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 3 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 4 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 5 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 6 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 7 of treatment duration ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 of treatment duration ]
    9-item depression rating scale.


Secondary Outcome Measures:
  • Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 24 hours ]
    21 item rating scale for depression symptoms.

  • Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 6 months ]
    21 item rating scale for depression symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ]
    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.

  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 6 months ]
    The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.

  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 24 hours ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).

  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ]
    The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).

  • Change from baseline in the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 24 hours ]
    The International Physical Activity Questionnaire is a measure of physical activity.

  • Change from baseline in the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 6 months ]
    The International Physical Activity Questionnaire is a measure of physical activity.


Estimated Enrollment: 128
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Initial treatment group
Group receives treatment.
Behavioral: Physical exercise program
An individualized physical exercise program, administered per internet. Some therapist-support will also be included.
No Intervention: Waiting list control group
The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings.

Detailed Description:
Previous research has found promising results regarding physical exercise as treatment of depression. This study will test a 9 week, internet-administered, therapist-assisted physical exercise program.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Satisfy DSM-IV criteria for depression
  • Living in Sweden and being able to read Swedish
  • Access to computer with internet connection

Exclusion Criteria:

  • Currently receiving other psychological treatment
  • Non-stable use of psychoactive medication
  • Deemed to suffer from a too severe depression, or being suicidal
  • Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573130


Locations
Sweden
Department of Psychology, Umeå University
Umeå, Västerbotten, Sweden, 90181
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
  More Information

Publications:
Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01573130     History of Changes
Other Study ID Numbers: Progredi
First Submitted: March 31, 2012
First Posted: April 6, 2012
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by Per Carlbring, PhD, Umeå University:
Depression
Physical exercise
Internet

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders