NCT01716832

Brief Summary

The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 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

March 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

6 months

First QC Date

October 24, 2012

Last Update Submit

February 20, 2018

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Cohens Perceived Stress Scale 14 Items

    4 weeks

Secondary Outcomes (3)

  • Quality of Life (SF 36)

    Baseline, 4 weeks, 12 weeks

  • Subjective Stress Level (Visual Analogue Scale)

    Baseline, 4 weeks, 12 weeks

  • Assessment of effect on a Likert - Scale

    4 weeks, 12 weeks

Study Arms (2)

Mindfulness walking

EXPERIMENTAL
Behavioral: Mindfulness Walking

No intervention (waiting list)

NO INTERVENTION

Interventions

Mindfulness WalkingBEHAVIORAL

Mindful walking in a small group twice a week for 60 minutes within 4 weeks.

Mindfulness walking

Eligibility Criteria

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

You may qualify if:

  • Healthy men and women between 18 and 65 years
  • Increased level of stress (visual analog scale \>40 mm (0-100))

You may not qualify if:

  • Regular walking training in the last 6 weeks
  • Medical therapy with psychopharmacological drugs
  • Regular mindfulness based meditations/exercises in the last 6 weeks
  • CAM therapies against stress in the last 6 weeks
  • medium or severe chronic diseases
  • Stress due to chronic diseases
  • Not being able to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Berlin

Berlin, 10117, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. MD

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 30, 2012

Study Start

March 1, 2011

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

DE(1)