Overview

This trial is active, not recruiting.

Condition child abuse survivors
Treatment mindfulness-based stress reduction program
Sponsor University of Maryland
Start date May 2007
End date March 2009
Trial size 20 participants
Trial identifier NCT00867802, H-28934 (HP-00041191)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Mindfulness-Based Stress Reduction program
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.

Primary Outcomes

Measure
To administer the Brief Symptom Inventory (BSI) questionnaire at each visit in order to assess psychological distress.
time frame: 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)
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

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.

Additional Information

Official title Mindfulness Intervention For Child Abuse Survivors
Principal investigator Elizabeth Pradhan, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by University of Maryland.