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

Primary Purpose

Stress, Psychological, Burnout, Professional, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Yoga
Mindfulness based cog psychotherapy
Cognitive psychotherapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress, Psychological focused on measuring Stress, Burnout, Anxiety, Depression

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control arm

Cognitive psychotherapy arm

Mindfulness based cog psychotherapy arm

Yoga treatment group

Arm Description

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.

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.

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.

Persons in this arm will practice yoga >= 5 time each week (2 times in a supervised group and the other times on their own).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Reduced cortisol secretion
We will measure cortisol level in a 24-hour sample of urine.

Full Information

First Posted
July 22, 2010
Last Updated
July 22, 2010
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01168661
Brief Title
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Official Title
Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Burnout, Professional, Anxiety, Depression
Keywords
Stress, Burnout, Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cognitive psychotherapy arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mindfulness based cog psychotherapy arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Yoga treatment group
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based cog psychotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive psychotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduced stress measured by qualitative questionnaires
Description
Level of stress will be measured by qualitiative questionnaries, including the Swedish Health-Related Quality of Life Survey (SWEQUAL).
Time Frame
5 months after start of treatment
Secondary Outcome Measure Information:
Title
Reduced cortisol secretion
Description
We will measure cortisol level in a 24-hour sample of urine.
Time Frame
5 months after start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid M Grensman, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bikash Dev Acharya, MSc Psyc
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14183
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29510704
Citation
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.
Results Reference
derived

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

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