An interventional study of Physical activity without motivational interviewing and Physical exercise with motivational interviewing in Depression, sponsored by Umeå University. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-01.
Sponsored by Umeå University · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 319 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Behavioral: Physical activity without motivational interviewing
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)
Behavioral: Physical activity without motivational interviewing
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)
Behavioral: Physical exercise with motivational interviewing
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)
Behavioral: Physical exercise with motivational interviewing
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)
Behavioral: Behavioral activation with rationale
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)
Behavioral: Behavioral activation with rationale
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)
Behavioral: Behavioral activation without rationale
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)
Behavioral: Behavioral activation without rationale
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.
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.
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.
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.
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.
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).
Time frame: Weekly during treatment period of 12 weeks
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).
Time frame: 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).
Time frame: 12 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).
Time frame: 24 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).
Time frame: Monthly, 0-24 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Time frame: 24 hours
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Time frame: 12 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Time frame: 24 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Time frame: Monthly, 0-24 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.
Time frame: 24 hours
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.
Time frame: 12 months
Change from baseline in the International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire is a measure of physical activity.
Time frame: 24 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.
Time frame: 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.
Time frame: 12 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.
Time frame: 24 months
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.
Time frame: Monthly, 0-24 months
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Umeå University