The Effects of Behavioral Activation and Physical Exercise on Depression

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Per Carlbring, PhD, Umeå University
ClinicalTrials.gov Identifier:
NCT01619930
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 12, 2012
June 12, 2012
August 2012
December 2014   (final data collection date for primary outcome measure)
  • Change from baseline in Patient Health Questionnaire (PHQ-9) [ Time Frame: Weekly during treatment period of 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Monthly, 0-24 months ] [ Designated as safety issue: No ]
    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).
Same as current
No Changes Posted
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Monthly, 0-24 months ] [ Designated as safety issue: No ]
    7-item screening form for Generalized Anxiety Disorder.
  • Change from baseline in the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The International Physical Activity Questionnaire is a measure of physical activity.
  • Change from baseline in the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The International Physical Activity Questionnaire is a measure of physical activity.
  • Change from baseline in the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The International Physical Activity Questionnaire is a measure of physical activity.
  • Change from baseline in Quality Of Life Inventory (QOLI) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Monthly, 0-24 months ] [ Designated as safety issue: No ]
    The Mini International Neuropsychiatric Interview is a short, structured interview designed for clinicians to diagnose axel I DSM-IV and ICD-10 disorders.
Same as current
Not Provided
Not Provided
 
The Effects of Behavioral Activation and Physical Exercise on Depression
The Effects on Depression of Internet-administered Behavioural Activation and Physical Exercise With Relapse Prevention, Motivational Interviewing and Treatment Rationale

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.

Previous research provide strong indications that behavioral activation and physical activation are effective treatments of depression. In this context, motivational interviewing has been indicated as a potential catalyst to induce activation, as well as an explicit treatment rationale. This study will also feature a relapse prevention program. Utilizing an advanced, randomization-based study design, this study will include all these interventions while maintaining a high scientific integrity.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Behavioral: 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.
  • Behavioral: 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: 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: 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.
  • Experimental: 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)

    Intervention: Behavioral: Physical activity without motivational interviewing
  • Experimental: 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)

    Intervention: Behavioral: Physical activity without motivational interviewing
  • Experimental: 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)

    Intervention: Behavioral: Physical exercise with motivational interviewing
  • Experimental: 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)

    Intervention: Behavioral: Physical exercise with motivational interviewing
  • Experimental: 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)

    Intervention: Behavioral: Behavioral activation with rationale
  • Experimental: 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)

    Intervention: Behavioral: Behavioral activation with rationale
  • Experimental: 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)

    Intervention: Behavioral: Behavioral activation without rationale
  • Experimental: 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)

    Intervention: Behavioral: Behavioral activation without rationale
  • No Intervention: 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.
    Interventions:
    • Behavioral: Physical activity without motivational interviewing
    • Behavioral: Physical exercise with motivational interviewing
    • Behavioral: Behavioral activation with rationale
    • Behavioral: Behavioral activation without rationale
Carlbring P, Lindner P, Martell C, Hassmén P, Forsberg L, Ström 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
500
May 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Per Carlbring, Professor +46 90-786 78 33 per.carlbring@psy.umu.se
Sweden
 
NCT01619930
FAS-FYS
No
Per Carlbring, PhD, Umeå University
Umeå University
Not Provided
Principal Investigator: Per Carlbring, Professor Department of Psychology, Umeå University
Umeå University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP