Treating Depression With Physical Exercise

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Physical exercise program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial treatment group<br>Group receives treatment. | Behavioral: Physical exercise program<br>* An individualized physical exercise program, administered per internet. Some therapist-support will also be included.<br>|
| No Intervention: Waiting list control group<br>The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Beck Depression Inventory (BDI) | 21 item rating scale for depression symptoms. | 24 hours | 
| Change from baseline in Beck Depression Inventory (BDI) | 21 item rating scale for depression symptoms. | 6 months | 
| Change from baseline in Beck Anxiety Inventory (BAI) | 21 item rating scale for anxiety symptoms. | 24 hours | 
| Change from baseline in Beck Anxiety Inventory (BAI) | 21 item rating scale for anxiety symptoms. | 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. | 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. | 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). | 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). | 6 months | 
| Change from baseline in the International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire is a measure of physical activity. | 24 hours | 
| Change from baseline in the International Physical Activity Questionnaire (IPAQ) | The International Physical Activity Questionnaire is a measure of physical activity. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Physical exercise, Internet