The Effects of Behavioral Activation and Physical Exercise on Depression
NCT ID: NCT01619930
Last Updated: 2016-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
319 participants
INTERVENTIONAL
2012-08-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1a
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)
Physical activity without motivational interviewing
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.
1b
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)
Physical activity without motivational interviewing
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.
2a
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)
Physical exercise with motivational interviewing
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.
2b
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)
Physical exercise with motivational interviewing
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.
3a
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 activation with rationale
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.
3b
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 activation with rationale
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.
4a
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 activation without rationale
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.
4b
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 activation without rationale
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.
Phase 1 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.
No interventions assigned to this group
Interventions
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Physical activity without motivational interviewing
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.
Physical exercise with motivational interviewing
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.
Behavioral activation with rationale
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.
Behavioral activation without rationale
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Per Carlbring, PhD
Professor
Principal Investigators
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Per Carlbring, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Psychology, Umeå University
Locations
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Department of Psychology, Umeå University
Umeå, Västerbotten County, Sweden
Countries
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References
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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.
Hlynsson JI, Kristjansson T, Andersson G, Carlbring P; ACTUA research group. Evaluating the necessity of booster sessions in relapse prevention for depression: a longitudinal study. Front Psychol. 2025 Jun 24;16:1568141. doi: 10.3389/fpsyg.2025.1568141. eCollection 2025.
Other Identifiers
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ACTUA
Identifier Type: -
Identifier Source: org_study_id