Clinical trial NCT00867802: Mindfulness Intervention For Child Abuse Survivors (MICAS)
Official title: Mindfulness Intervention For Child Abuse Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse Survivors
Keywords: MICAS
MBSR
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2009-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.
timeFrame: 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kernan Hospital
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Elizabeth Pradhan, PhD
role: PRINCIPAL_INVESTIGATOR
References: