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.

Study Overview

• Status: Completed
• Conditions: Depression; Burnout, Professional; Stress, Psychological; Anxiety
• Intervention / Treatment: Behavioral: Cognitive psychotherapy; Behavioral: Mindfulness based cog psychotherapy; Behavioral: Yoga

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, 14183
      • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced cortisol secretion	We will measure cortisol level in a 24-hour sample of urine.	5 months after start of treatment

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Astrid M Grensman, MD, Karolinska Institutet; Principal Investigator: Bikash Dev Acharya, MSc Psyc, Karolinska Institutet

Publications and helpful links

General Publications

• Grensman A, Acharya BD, Wandell P, Nilsson GH, Falkenberg T, Sundin O, Werner S. Effect of traditional yoga, mindfulness-based cognitive therapy, and cognitive behavioral therapy, on health related quality of life: a randomized controlled trial on patients on sick leave because of burnout. BMC Complement Altern Med. 2018 Mar 6;18(1):80. doi: 10.1186/s12906-018-2141-9.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 23, 2010
• Last Update Submitted That Met QC Criteria: July 22, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Stress; Burnout
• Additional Relevant MeSH Terms: Behavioral Symptoms; Occupational Stress; Occupational Diseases; Depression; Burnout, Professional; Burnout, Psychological; Stress, Psychological
• Other Study ID Numbers: Pickup 2003