NCT00867802

Brief Summary

The purpose of this study is to assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 24, 2009

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

December 8, 2008

Last Update Submit

February 25, 2022

Conditions

Keywords

MICASMBSR

Outcome Measures

Primary Outcomes (1)

  • To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.

    6 weeks

Secondary Outcomes (1)

  • Trauma Symptom Inventory to all participants at each visit. Administer the Beck Depression Inventory (BDI) to all participants. Functional Assessment of Chronic Illness Therapy spiritual Well-Being (FACIT-SP)

    24 weeks

Study Arms (1)

Mindfulness- Based Stress Reduction: Active Comparator

EXPERIMENTAL

Mindfulness-Based Stress Reduction program

Behavioral: Mindfulness-Based Stress Reduction program

Interventions

Mindfulness- Based Stress Reduction comprising of 8 classes and a one-day retreat, taught over a period of 6 weeks. Intervention also includes practice at home for 20-30 minutes.

Mindfulness- Based Stress Reduction: Active Comparator

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A history of child abuse, as attested by the potential participant
  • Currently in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker).
  • Plans to remain in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker) for the duration of the study.
  • Recommendation made by the potential participant's licensed psychotherapist (psychiatrist, psychologist, social worker) the Mindfulness-Based Stress Reduction program would be an appropriate adjunct therapy for his or her client.
  • Score of 0.50 or higher on the General Severity Index of the Brief Symptom Inventory, indicating psychological distress above the normal population.
  • Aged 21 or above.
  • Ability to read and write English.
  • Able to attend 10 courses and assessment visits over a 6-week period.
  • Willing to practice skills for 20-30 minutes per day 6 days a week, during the course.

You may not qualify if:

  • Major psychiatric illness (bipolar disorder, schizophrenia, dissociative identity disorder, or others).
  • Active alcoholism or drug dependency.
  • Any psychological or physical illness the investigator feels would prohibit full participation in the course.
  • Currently enrolled in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kernan Hospital

Baltimore, Maryland, 21207, United States

Location

Study Officials

  • Elizabeth Pradhan, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research Center for Integrative Medicine, University of Maryland

Study Record Dates

First Submitted

December 8, 2008

First Posted

March 24, 2009

Study Start

May 1, 2007

Primary Completion

September 1, 2008

Study Completion

March 1, 2009

Last Updated

March 14, 2022

Record last verified: 2022-02

Locations