NCT04039074

Brief Summary

The aim of this study is to measure the effects of three stress reduction methods on patients with stress and stress associated complaints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

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

First Submitted

Initial submission to the registry

July 28, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

July 28, 2019

Last Update Submit

September 28, 2022

Conditions

Stress, Psychological

Keywords

YogaMeditationProgressive muscle relaxationStressEducation

Outcome Measures

Primary Outcomes (1)

  • Stress questionnaire (Cohen Perceived Stress Scale, CPSS)

    Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.

    Date of inclusion (baseline), after 12 weeks, after 24 weeks

Secondary Outcomes (32)

  • Medical Outcomes Study Short Form Quality of Life (MOS SF-36)

    Date of inclusion (baseline), after 12 weeks, after 24 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    Date of inclusion (baseline), after 12 weeks, after 24 weeks

  • Zerssen symptom list (B-LR and B-LR')

    Date of inclusion (baseline), after 12 weeks, after 24 weeks

  • International Physical Activity Questionnaire (IPAQ)

    Date of inclusion (baseline), after 12 weeks, after 24 weeks

  • Maslach Burnout Inventory (MBI)

    Date of inclusion (baseline), after 12 weeks, after 24 weeks

  • +27 more secondary outcomes

Other Outcomes (1)

  • Qualitative interviews in focus groups interviews

    12 weeks after inclusion

Study Arms (3)

Integrative Yoga

EXPERIMENTAL

A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.

Behavioral: Integrative Yoga

Iyengar yoga

ACTIVE COMPARATOR

A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).

Behavioral: Iyengar Yoga

Mindfulness

ACTIVE COMPARATOR

A 12-week mindfulness intervention designed for the healthy handling of stress.

Behavioral: Mindfulness

Interventions

Integrative YogaBEHAVIORAL

A 12-week "Integrative Yoga" intervention which has meditative and psycho-educational components corresponding to traditional yoga practice.

Integrative Yoga
Iyengar YogaBEHAVIORAL

A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).

Iyengar yoga
MindfulnessBEHAVIORAL

A 12-week mindfulness intervention designed for the healthy handling of stress.

Mindfulness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month and at least 3 of the following 8 stress symptoms: sleep disorder, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disorder, exhaustion, nervousness/irritability, stress-associated digestive problems

You may not qualify if:

  • serious acute or chronic diseases
  • pregnancy or lactation
  • known serious mental illness
  • immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
  • participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andreas Michalsen, Prof. Dr.

    Charite - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 28, 2019

First Posted

July 31, 2019

Study Start

July 29, 2019

Primary Completion

January 21, 2021

Study Completion

June 30, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

Locations

DE(1)