Mindfulness Intervention For Child Abuse Survivors (MICAS) - Full Text View

Sponsored by:	University of Maryland
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00867802

Purpose

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.

Condition	Intervention
Child Abuse Survivors	Behavioral: Mindfulness-Based Stress Reduction program

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Mindfulness Intervention For Child Abuse Survivors

Further study details as provided by University of Maryland:

Primary Outcome Measures:

To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	May 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mindfulness- Based Stress Reduction: Active Comparator: Experimental Mindfulness-Based Stress Reduction program	Behavioral: Mindfulness-Based Stress Reduction program 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.

Detailed Description:

The specific aims of the project are:

To determine whether Mindfulness- Based Stress Reduction program is associated with a reduction in symptoms of depression, anxiety, and psychological distress.
To assess indications of efficacy, assess feasibility of enrollment and compliance among this patient population
Provide pilot data that can be used to apply for larger grants to more fully develop this approach

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867802

Locations

United States, Maryland
Kernan Hospital
Baltimore, Maryland, United States, 21207

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Elizabeth Pradhan, PhD

University of Maryland, School of Medicine

More Information

No publications provided

Responsible Party:	University of Maryland School of Medicine ( Elizabeth Pradhan )
Study ID Numbers:	H-28934 (HP-00041191)
Study First Received:	December 8, 2008
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00867802 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

MICAS
MBSR

ClinicalTrials.gov processed this record on May 07, 2009