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Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout

This study has been completed.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01168661
First received: July 22, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

July 22, 2010
July 22, 2010
August 2007
April 2010   (final data collection date for primary outcome measure)
Reduced stress measured by qualitative questionnaires [ Time Frame: 5 months after start of treatment ] [ Designated as safety issue: No ]
Level of stress will be measured by qualitiative questionnaries, including the Swedish Health-Related Quality of Life Survey (SWEQUAL).
Same as current
No Changes Posted
Reduced cortisol secretion [ Time Frame: 5 months after start of treatment ] [ Designated as safety issue: No ]
We will measure cortisol level in a 24-hour sample of urine.
Same as current
Not Provided
Not Provided
 
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout

The purpose of this study is to investigate if treatment with yoga or mindfulness has a more profound and longstanding effect on stress and burnout than treatment with cognitive psychotherapy alone.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stress, Psychological
  • Burnout, Professional
  • Anxiety
  • Depression
  • Behavioral: Yoga
    Participants in this intervention arm will practice yoga (physical postures, breathing exercises, and meditation) >= 5 times a week (twice in a supervised group and the rest on their own). Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. They will follow this schedule for 20 weeks.
  • Behavioral: Mindfulness based cog psychotherapy
    Participants in this arm will attend a weekly group meeting to practice mindfulness based cognitive psychotherapy. They will also practice >= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.
  • Behavioral: Cognitive psychotherapy
    Participants in this arm will attend a weekly group meeting to practice cognitive psychotherapy. They will also practice >= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.
  • No Intervention: Control arm
    Participants in this arm will be recruited from the group who applied to participate in the study and fulfilled the inclusion criteria but for various reasons (such as time constraints) could not participate.
  • Active Comparator: Cognitive psychotherapy arm
    In this arm, participants will attend a group meeting to practice cognitive psychotherapy once a week. They will also practice on their own >= 4 times a week.
    Intervention: Behavioral: Cognitive psychotherapy
  • Active Comparator: Mindfulness based cog psychotherapy arm
    In this arm, participants will attend a group meeting to practice mindfulness based cognitive psychotherapy once a week. They will also practice on their own >= 4 times a week.
    Intervention: Behavioral: Mindfulness based cog psychotherapy
  • Active Comparator: Yoga treatment group
    Persons in this arm will practice yoga >= 5 time each week (2 times in a supervised group and the other times on their own).
    Intervention: Behavioral: Yoga
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • On sick leave at least 50% at the beginning of the study.
  • Sick leave for a maximum of 1 year if on full-time sick leave at the beginning of the study or for a maximum of 3 years if on part-time sick leave at the beginning of the study.
  • Speak Swedish well enough to participate in the study interventions.
  • Body mass index (BMI) of between 18 and 30.
  • Meet the diagnostic criteria for burnout syndrome from the Swedish National Board of Health and Welfare.

Exclusion Criteria:

  • Medication, including all medication or topical skin preparations with cortisone in any form. Exceptions: Antidepressants, contraceptives, hormone replacement therapy for hypothyroidism if hormone levels were within the normal range, and hormone replacement therapy to treat menopausal symptoms. To receive an exception for medication, a participant had to take the same medication at the same dose at both blood tests.
Both
16 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01168661
Pickup 2003
No
Astrid Grensman, MD, Karolinska Institutet, Center for Family and Community Medicine
Karolinska Institutet
Stockholm County Council, Sweden
Principal Investigator: Astrid M Grensman, MD Karolinska Institutet
Principal Investigator: Bikash Dev Acharya, MSc Psyc Karolinska Institutet
Karolinska Institutet
July 2010

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