Treating Depression With Physical Exercise

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573130
• Other study ID #: Progredi
• Status: Completed
• Phase: N/A
• First received: March 31, 2012
• Last updated: October 29, 2016
• Start date: March 2012
• Est. completion date: October 2013

Study information

• Verified date: October 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Psychology, Umeå University	Umeå	Västerbotten

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Ström M, Uckelstam CJ, Andersson G, Hassmén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	24 hours	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	6 months	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 1 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 2 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 3 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 4 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 5 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 6 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 7 of treatment duration	No
Primary	Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)	9-item depression rating scale.	Week 8 of treatment duration	No
Secondary	Change from baseline in Beck Depression Inventory (BDI)	21 item rating scale for depression symptoms.	24 hours	No
Secondary	Change from baseline in Beck Depression Inventory (BDI)	21 item rating scale for depression symptoms.	6 months	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	21 item rating scale for anxiety symptoms.	24 hours	No
Secondary	Change from baseline in Beck Anxiety Inventory (BAI)	21 item rating scale for anxiety symptoms.	6 months	No
Secondary	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.	24 hours	No
Secondary	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.	6 months	No
Secondary	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).	24 hours	No
Secondary	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).	6 months	No
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity.	24 hours	No
Secondary	Change from baseline in the International Physical Activity Questionnaire (IPAQ)	The International Physical Activity Questionnaire is a measure of physical activity.	6 months	No