Treating Depression With Physical Exercise

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Umeå University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01573130
First received: March 31, 2012
Last updated: April 4, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Umeå University:

Primary Outcome Measures:
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 1 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 2 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 3 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 4 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 5 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 6 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 7 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.

  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Week 8 of treatment duration ] [ Designated as safety issue: No ]
    9-item depression rating scale.


Secondary Outcome Measures:
  • Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    21 item rating scale for depression symptoms.

  • Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    21 item rating scale for depression symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Beck Anxiety Inventory (BAI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    21 item rating scale for anxiety symptoms.

  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The International Physical Activity Questionnaire is a measure of physical activity.


Estimated Enrollment: 128
Study Start Date: March 2012
Estimated Study Completion Date: July 2013
Estimated 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.
Behavioral: Physical exercise program
An individualized physical exercise program, administered per internet. Some therapist-support will also be included.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573130

Contacts
Contact: Per Carlbring, Professor +46 90-786 78 33 per.carlbring@psy.umu.se

Locations
Sweden
Department of Psychology, Umeå University Recruiting
Umeå, Västerbotten, Sweden, 90181
Contact: Per Carlbring, Professor    +46 90-786 78 33    per.carlbring@psy.umu.se   
Principal Investigator: Per Carlbring, Professor         
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
  More Information

No publications provided

Responsible Party: Per Carlbring, PhD, Professor, Umeå University
ClinicalTrials.gov Identifier: NCT01573130     History of Changes
Other Study ID Numbers: Progredi
Study First Received: March 31, 2012
Last Updated: April 4, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Depression
Physical exercise
Internet

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

ClinicalTrials.gov processed this record on July 22, 2014