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Mindfulness Intervention For Child Abuse Survivors (MICAS) (MICAS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00867802
First Posted: March 24, 2009
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian Berman, University of Maryland
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness Intervention For Child Abuse Survivors

Further study details as provided by Brian Berman, 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 ]

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 ]

Estimated Enrollment: 20
Study Start Date: May 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness- Based Stress Reduction: Active Comparator
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:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  More Information

Responsible Party: Brian Berman, Director of Research Center for Integrative Medicine, University of Maryland, University of Maryland
ClinicalTrials.gov Identifier: NCT00867802     History of Changes
Other Study ID Numbers: HP-00041191
First Submitted: December 8, 2008
First Posted: March 24, 2009
Last Update Posted: April 17, 2017
Last Verified: April 2017

Keywords provided by Brian Berman, University of Maryland:
MICAS
MBSR