Treating Depression With Physical Exercise - Full Text View

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:

MedlinePlus related topics: Anxiety Depression Exercise and Physical Fitness

U.S. FDA Resources

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

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 May 19, 2013