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

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT01168661

Collaborator

Region Stockholm (Other)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological Burnout, Professional Anxiety Depression	Behavioral: Yoga Behavioral: Mindfulness based cog psychotherapy Behavioral: Cognitive psychotherapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Reduced stress measured by qualitative questionnaires [5 months after start of treatment]
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 [5 months after start of treatment]
We will measure cortisol level in a 24-hour sample of urine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.