search
Back to results

Treating Depression With Physical Exercise

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical exercise program
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Physical exercise, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychology, Umeå University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Initial treatment group

Waiting list control group

Arm Description

Group receives treatment.

The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings.

Outcomes

Primary Outcome Measures

Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.

Secondary Outcome Measures

Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Change from baseline in Beck Depression Inventory (BDI)
21 item rating scale for depression symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
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.
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.
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).
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).
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.

Full Information

First Posted
March 31, 2012
Last Updated
October 29, 2016
Sponsor
Umeå University
search

1. Study Identification

Unique Protocol Identification Number
NCT01573130
Brief Title
Treating Depression With Physical Exercise
Official Title
An Internet-administered, Therapist-supported Physical Exercise Program for the Treatment of Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Physical exercise, Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Initial treatment group
Arm Type
Experimental
Arm Description
Group receives treatment.
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
The waiting list control group receives treatment after 9 weeks, before which they do weekly ratings.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise program
Intervention Description
An individualized physical exercise program, administered per internet. Some therapist-support will also be included.
Primary Outcome Measure Information:
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
24 hours
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
6 months
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 1 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 2 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 3 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 4 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 5 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 6 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 7 of treatment duration
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
9-item depression rating scale.
Time Frame
Week 8 of treatment duration
Secondary Outcome Measure Information:
Title
Change from baseline in Beck Depression Inventory (BDI)
Description
21 item rating scale for depression symptoms.
Time Frame
24 hours
Title
Change from baseline in Beck Depression Inventory (BDI)
Description
21 item rating scale for depression symptoms.
Time Frame
6 months
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
24 hours
Title
Change from baseline in Beck Anxiety Inventory (BAI)
Description
21 item rating scale for anxiety symptoms.
Time Frame
6 months
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
24 hours
Title
Change from baseline in Quality Of Life Inventory (QOLI)
Description
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.
Time Frame
6 months
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
24 hours
Title
Change from baseline in Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
6 months
Title
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire is a measure of physical activity.
Time Frame
24 hours
Title
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
Description
The International Physical Activity Questionnaire is a measure of physical activity.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Carlbring, Professor
Organizational Affiliation
Department of Psychology, Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Umeå University
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
90181
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24109561
Citation
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.
Results Reference
result

Learn more about this trial

Treating Depression With Physical Exercise

We'll reach out to this number within 24 hrs