Treating Depression With Physical Exercise

A study testing Physical exercise program in people with Depression, run by Umeå University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression
What is being tested?: Physical exercise program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteSweden
Study dates: Mar 2012to Oct 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Department of Psychology, Umeå University
Umeå, Västerbotten County, 90181

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Conditions: Depression
Being tested: Physical exercise program
Keywords: Depression, Physical exercise, Internet
Medical subject headings: Depression, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical exercise programBehavioural
An individualized physical exercise program, administered per internet. Some therapist-support will also be included.

Study groups in NCT01573130
Study group	Role	What they receive
Initial treatment group	Experimental	Group receives treatment. Receives: Behavioral: Physical exercise program
Waiting list control group	No intervention	The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Measured: 24 hours
Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Measured: 6 months
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 6 months
Change from baseline in Quality Of Life Inventory (QOLI)
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.
Measured: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
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.
Measured: 6 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
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).
Measured: 24 hours
Change from baseline in Patient Health Questionnaire (PHQ-9)
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).
Measured: 6 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.
Measured: 24 hours
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Oct 2013

First posted6 Apr 2012 (estimated)
Study startMar 2012
Primary completionJun 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by Umeå UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 128 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01573130
Sponsor's protocol ID: Progredi
Status last verified: Oct 2016
First submitted: 31 Mar 2012
Last updated: 1 Nov 2016
Results posted: No
Data monitoring committee: No

Publications

Strom M, Uckelstam CJ, Andersson G, Hassmen P, Umefjord G, Carlbring P. Internet-delivered therapist-guided physical activity for mild to moderate depression: a randomized controlled trial. PeerJ. 2013 Oct 3;1:e178. doi: 10.7717/peerj.178. eCollection 2013.
PubMed 24109561

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Internet-administered, Therapist-supported Physical Exercise Program for the Treatment of Depression
ClinicalTrials.gov ID: NCT01573130
Acronym / sponsor ID: Progredi
Conditions: Depression
Keywords: Depression, Physical exercise, Internet
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (estimated)
Lead sponsor: Umeå UniversityUniversity, hospital or other
Study start: Mar 2012
Primary completion: Jun 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 6 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Initial treatment group	Experimental	Behavioral: Physical exercise programGroup receives treatment.
Waiting list control group	No intervention	–The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical exercise programAn individualized physical exercise program, administered per internet. Some therapist-support will also be included.	Behavioural	Initial treatment group

Primary outcome

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.

10 secondary outcomes

Change from baseline in Beck Depression Inventory (BDI)
Time frame: 24 hours
Change from baseline in Beck Depression Inventory (BDI)
Time frame: 6 months
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 6 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 6 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: 24 hours
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time frame: 24 hours
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
Results publication: PubMed 24109561Strom M, Uckelstam CJ, Andersson G, Hassmen P, Umefjord G, Carlbring P. Internet-delivered therapist-guided physical activity for mild to moderate depression: a randomized controlled trial. PeerJ. 2013 Oct 3;1:e178. doi: 10.7717/peerj.178. eCollection 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Per Carlbring, Professor principal investigator

Department of Psychology, Umeå University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise program in people with Depression, run by Umeå University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 24 hours). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01573130, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.