NCT00842738

Brief Summary

In this study two questions will be answered:

  • can mindfulness meditation help cell-changed on the cervix to disappear?
  • can mindfulness meditation lower the psychological distress when women have abnormal cervical cancer screening results?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

February 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 14, 2010

Status Verified

February 1, 2009

Enrollment Period

1.3 years

First QC Date

February 10, 2009

Last Update Submit

January 13, 2010

Conditions

Cervical Dysplasia

Keywords

ScreeningCervical cancerCervical dysplasiaAdverse psychosocial effectsAlternative treatment

Outcome Measures

Primary Outcomes (1)

  • The degree of cervical dysplasia

    6 months after screening

Secondary Outcomes (1)

  • Psychosocial consequences measured with the COS-CC questionnaire

    1 week, 3 and 9 months after screening

Study Arms (3)

Mindfulness meditation

ACTIVE COMPARATOR

Women with mild dysplasia offered mindfulness meditation

Behavioral: Mindfulness meditation

No meditation

OTHER

Women with mild dysplasia offered health care services as usual

Other: No meditation

Controls

OTHER

Women with normal cervical cells

Other: Controls

Interventions

Mindfulness meditationBEHAVIORAL

Mindfulness meditation

Mindfulness meditation
No meditationOTHER

Health care services as usual

No meditation
ControlsOTHER

No intervention

Controls

Eligibility Criteria

Age23 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 23-29 years
  • Participated in cervical cancer screening
  • Having mild dysplasia and normal screening results

You may not qualify if:

  • Women who have previously had dysplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department and Research Unit of General Practice, Institute of Public Health

Copenhagen, 1014, Denmark

Location

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 12, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2011

Last Updated

January 14, 2010

Record last verified: 2009-02

Locations

DK(1)