Treating Depression With Physical Exercise

October 29, 2016 updated by: Per Carlbring, PhD, Umeå University

An Internet-administered, Therapist-supported Physical Exercise Program for the Treatment of Depression

The purpose of the study is to investigate the effects of an internet-administered, therapist-assisted physical exercise program for the treatment of depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 90181
        • Department of Psychology, Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 24 hours
9-item depression rating scale.
24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: 6 months
9-item depression rating scale.
6 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 1 of treatment duration
9-item depression rating scale.
Week 1 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 2 of treatment duration
9-item depression rating scale.
Week 2 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 3 of treatment duration
9-item depression rating scale.
Week 3 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 4 of treatment duration
9-item depression rating scale.
Week 4 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 5 of treatment duration
9-item depression rating scale.
Week 5 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 6 of treatment duration
9-item depression rating scale.
Week 6 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 7 of treatment duration
9-item depression rating scale.
Week 7 of treatment duration
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time Frame: Week 8 of treatment duration
9-item depression rating scale.
Week 8 of treatment duration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Beck Anxiety Inventory (BAI)
Time Frame: 24 hours
21 item rating scale for anxiety symptoms.
24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
Time Frame: 6 months
21 item rating scale for anxiety symptoms.
6 months
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.
24 hours
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.
6 months
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).
24 hours
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).
6 months
Change from baseline in Beck Depression Inventory (BDI)
Time Frame: 24 hours
21 item rating scale for depression symptoms.
24 hours
Change from baseline in Beck Depression Inventory (BDI)
Time Frame: 6 months
21 item rating scale for depression symptoms.
6 months
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.
24 hours
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

March 31, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 29, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progredi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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