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
  Purpose

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.


Condition Intervention
Stress, Psychological
Burnout, Professional
Anxiety
Depression
Behavioral: Yoga
Behavioral: Mindfulness based cog psychotherapy
Behavioral: Cognitive psychotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 90
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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).
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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168661

Locations
Sweden
Karolinska Institutet
Stockholm, Huddinge, Sweden, 14183
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Astrid M Grensman, MD Karolinska Institutet
Principal Investigator: Bikash Dev Acharya, MSc Psyc Karolinska Institutet
  More Information

No publications provided

Responsible Party: Astrid Grensman, MD, Karolinska Institutet, Center for Family and Community Medicine
ClinicalTrials.gov Identifier: NCT01168661     History of Changes
Other Study ID Numbers: Pickup 2003
Study First Received: July 22, 2010
Last Updated: July 22, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Stress
Burnout
Anxiety
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress, Psychological
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014