Back to resultsThe Effects of Behavioral Activation and Physical Exercise on Depression
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activity without motivational interviewing
Physical exercise with motivational interviewing
Behavioral activation with rationale
Behavioral activation without rationale
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Behavioral activation
Eligibility Criteria
Inclusion Criteria:
- Satisfy DSM-IV (or DSM-V) criteria for depression, with depression being primary diagnosis
- Scoring within the interval 15-35 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
- 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
- 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 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
1a
1b
2a
2b
3a
3b
4a
4b
Phase 1 Waiting list control group
Arm Description
In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)
In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)
In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)
In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)
In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)
In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)
In phase 1, group 4 undergoes behavioral activation without added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)
In phase 1, group 4 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described. n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)
Control group during phase 1, in parallel with treatment groups 1-4. Weekly self-report measurements, the results of which are conveyed in the form of individualized feedback. After 12 weeks, the participants of the control group (n = 100) are randomized to one four phase 1 active treatment groups (1-4) and receive treatment accordingly.
Outcomes
Primary Outcome Measures
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 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 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).
Secondary Outcome Measures
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
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.
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 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 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 MINI
The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01619930
Brief Title
The Effects of Behavioral Activation and Physical Exercise on Depression
Official Title
The Effects on Depression of Internet-administered Behavioural Activation and Physical Exercise With Treatment Rationale and Relapse Prevention: Study Protocol for a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
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 this study is to compare an internet-based behavioral activation program with a physical activation program, as treatments for mild to moderate depression. The added effect of rationale and motivational interviewing will also be studied, as well as the effects of relapse prevention program.
Detailed Description
BACKGROUND:
Despite their potential as low-threshold, low-cost and high-flexibility treatments of depression, behavioural activation and physical exercise have not yet been directly compared. This study will examine the effects of these interventions, administered via the Internet. The added effect of providing a treatment rationale will also be studied, as well as a relapse prevention program featuring cognitive behavioural therapy components.
METHODS/DESIGN:
This randomised controlled trial will include 500 participants meeting the diagnostic criteria for major depression, recruited in multiple cycles and randomised to either a waiting list control group with delayed treatment, or one of the four treatment groups: (1) physical exercise without a clear treatment rationale; (2) physical exercise with treatment rationale; (3) behavioural activation with treatment rationale; or (4) behavioural activation without a clear treatment rationale. Post treatment, half of the participants will be offered a relapse prevention program. Primary outcome measure will be the Patient Health Questionnaire 9-item. Secondary measures include diagnostic criteria for depression, as well as self-reported anxiety, physical activity and quality of life. Measurements - done via telephone and the Internet - will be collected pre-treatment, weekly during treatment period, immediately post treatment and then monthly during a 24-month follow-up period.
DISCUSSION:
The results of this study will constitute an important contribution to the body of knowledge of the respective interventions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Behavioral activation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1a
Arm Type
Experimental
Arm Description
In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)
Arm Title
1b
Arm Type
Experimental
Arm Description
In phase 1, group 1 undergoes physical activation without added motivation interviewing. Post-treatment (phase 2), group 1 is divided by randomization into group 1a and 1b, where 1a receives relapse prevention and 1b does not. Both 1a and 1b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 1 + 12 from waiting list control group)
Arm Title
2a
Arm Type
Experimental
Arm Description
In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)
Arm Title
2b
Arm Type
Experimental
Arm Description
In phase 1, group 2 undergoes physical activation with added motivation interviewing. Post-treatment (phase 2), group 2 is divided by randomization into group 2a and 2b, where 2a receives relapse prevention and 2b does not. Both 2a and 2b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 2 + 12 from waiting list control group)
Arm Title
3a
Arm Type
Experimental
Arm Description
In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)
Arm Title
3b
Arm Type
Experimental
Arm Description
In phase 1, group 3 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 3 is divided by randomization into group 3a and 3b, where 3a receives relapse prevention and 3b does not. Both 3a and 3b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 3 + 12 from waiting list control group)
Arm Title
4a
Arm Type
Experimental
Arm Description
In phase 1, group 4 undergoes behavioral activation without added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)
Arm Title
4b
Arm Type
Experimental
Arm Description
In phase 1, group 4 undergoes behavioral activation with added motivation interviewing. Post-treatment (phase 2), group 4 is divided by randomization into group 4a and 4b, where 4a receives relapse prevention and 4b does not. Both 4a and 4b undergo post-treatment measurements as previously described.
n = 50 + 12 = 62 (50 from group 4 + 12 from waiting list control group)
Arm Title
Phase 1 Waiting list control group
Arm Type
No Intervention
Arm Description
Control group during phase 1, in parallel with treatment groups 1-4. Weekly self-report measurements, the results of which are conveyed in the form of individualized feedback. After 12 weeks, the participants of the control group (n = 100) are randomized to one four phase 1 active treatment groups (1-4) and receive treatment accordingly.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity without motivational interviewing
Intervention Description
Focus is on physical exercise, motivated by research findings that it has a positive effect on depressive symptoms. An individualized exercise program is constructed, to be followed by the respective participant. A user-friendly pulse watch will be mailed to participants. Exercise is monitored through online self-registration with automated feedback.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercise with motivational interviewing
Intervention Description
Focus is on physical exercise, motivated by research findings that it has a positive effect on depressive symptoms. An individualized exercise program is constructed, to be followed by the respective participant. A user-friendly pulse watch will be mailed to participants. Exercise is monitored through online self-registration with automated feedback. An initial motivational interview (MI) per telephone is also conducted, to explore the intrinsic motivation to change in participants.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation with rationale
Intervention Description
A behavioral activation program, based on the TRAP-TRAC model according to which suffering individuals are trapped in a vicious circle of avoidance and ever fewer reinforcers, leading to increasing discomfort. To break free of this vicious circle, patients have to replace avoidance patterns with alternative coping strategies. Unlike previous applications of this program done in the U.S., this study will feature an internet-based administration. Approximately 15 minutes of electronic therapist support will be included per week.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation without rationale
Intervention Description
A behavioral activation program without TRAP-TRAC rationale, but with some encouragement provided ("Activate yourself and feel better!"). Approximately 15 minutes of electronic therapist support will be included per week.
Primary Outcome Measure Information:
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
Weekly during treatment period of 12 weeks
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
12 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 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
Monthly, 0-24 months
Secondary Outcome Measure Information:
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
24 hours
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
12 months
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
24 months
Title
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Description
7-item screening form for Generalized Anxiety Disorder.
Time Frame
Monthly, 0-24 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
12 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 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
12 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 months
Title
Change from baseline in MINI
Description
The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
Time Frame
Monthly, 0-24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Satisfy DSM-IV (or DSM-V) criteria for depression, with depression being primary diagnosis
Scoring within the interval 15-35 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
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
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
23374879
Citation
Carlbring P, Lindner P, Martell C, Hassmen P, Forsberg L, Strom L, Andersson G. The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial. Trials. 2013 Feb 2;14:35. doi: 10.1186/1745-6215-14-35.
Results Reference
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The Effects of Behavioral Activation and Physical Exercise on Depression
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