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

Mindfulness Intervention For Child Abuse Survivors

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.

Study Overview

• Status: Completed
• Conditions: Child Abuse Survivors
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction program

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Elizabeth Pradhan, PhD, University of Maryland School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: December 8, 2008
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 24, 2009

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: MBSR; MICAS
• Other Study ID Numbers: HP-00041191