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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168661
• Other study ID #: Pickup 2003
• Status: Completed
• Phase: N/A
• First received: July 22, 2010
• Last updated: July 22, 2010
• Start date: August 2007
• Est. completion date: April 2010

Study information

• Verified date: July 2010
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Depression
• Stress, Psychological

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced stress measured by qualitative questionnaires	Level of stress will be measured by qualitiative questionnaries, including the Swedish Health-Related Quality of Life Survey (SWEQUAL).	5 months after start of treatment	No
Secondary	Reduced cortisol secretion	We will measure cortisol level in a 24-hour sample of urine.	5 months after start of treatment	No