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November 29, 2006

MINDFULL: A Randomized, Controlled Pilot Study of a Cognitive Rehabilitation Intervention Program in Systemic Lupus Erythematosus Patients

IRB Number: 23081

Institutional Review Board
Hospital for Special Surgery


The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Melanie J. Harrison, MD, MS

Co-Investigators

Joan Toglia, MA, OTR/L
Roberta Horton, ACSW, CSW
Laura Robbins, DSW
Lisa Ravdin, PhD
Jamie Weiss, BA
Katy Flynn-Meketon, BA
Ania Rodney, BA
Deborah Miller, BS
Janine Fernandez

Summary

MINDFULL is an experimental educational program for women with lupus who have experienced cognitive difficulties, that is problems with memory and learning. A total of 40 patients will be enrolled in the study. All subjects who participate in this study are guaranteed to have the opportunity to participate in the program.

The intervention consists of 10 weekly sessions, about two hours each, which will give participants information about cognitive function as well as teach them effective strategies for improving cognitive abilities to better the daily life of people with lupus. They will also participate in a discussion group (informative exchange).

The subject will also be asked to meet with the research assistant in private interviews before and after the 10 session course during which she will complete additional questionnaires about herself and her lupus, as well as complete several tests of her cognitive abilities.

Participants will receive $20 for each of the ten weekly sessions as well as each interview they attend. Refreshments will also be provided at each group meeting.

Inclusion/Exclusion Criteria

Inclusion criteria:

  • Female
  • 25 to 60 years of age
  • SLE defined by the presence of at least 4 of the 11 revised 1982
  • ACR criteria
  • Fluency in English
  • Ability to read normal newsprint
  • Ability to hear a normal speaking voice
  • Estimated premorbid verbal IQ›90
  • Functional difficulties due to cognitive dysfunction

Exclusion criteria:

  • Global cognitive impairment or a suspicion of dementia
  • Physical or mental disabilities which would seriously affect the performance of the cognitive tests or participation in the intervention.  These include, severe dominant hand deformity or dysfunction, aphasia, mental retardation, and those patients who are cognitively or psychiatrically lacking the capacity to give informed consent.
  • Known scheduling conflict or logistical issue that is likely to prevent the subject from attending all sessions of the intervention. 
  • Refusal to participate
  • Prior participation in a cognitive rehabilitation program (group or individual)

Contact Information

Study Coordinator
Jamie Weiss
212.606.1867





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