NCT01168661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

2.7 years

First QC Date

July 22, 2010

Last Update Submit

July 22, 2010

Conditions

Keywords

StressBurnoutAnxietyDepression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reduced cortisol secretion

    5 months after start of treatment

Study Arms (4)

Control arm

NO INTERVENTION

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.

Cognitive psychotherapy arm

ACTIVE COMPARATOR

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

Mindfulness based cog psychotherapy arm

ACTIVE COMPARATOR

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

Yoga treatment group

ACTIVE COMPARATOR

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

Interventions

YogaBEHAVIORAL

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.

Yoga treatment group

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.

Mindfulness based cog psychotherapy arm

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.

Cognitive psychotherapy arm

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Huddinge, 14183, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stress, PsychologicalBurnout, ProfessionalAnxiety DisordersDepressionBurnout, Psychological

Interventions

YogaCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorOccupational StressOccupational DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Astrid M Grensman, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR
  • Bikash Dev Acharya, MSc Psyc

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

August 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations