Wellness Interventions After Transplant Study

Summary

The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target. This trial is no longer recruiting new patients. Those currently enrolled will be followed for a year to evaluate trial outcomes.

The purpose of this trial is to determine if training in Mindfulness-Based Stress Reduction can reduce symptom distress and improve quality of life in solid organ transplant recipients. Primary study outcomes are depression, anxiety and insomnia symptoms, measured by well-validated self-report scales. The impact of this program on objectively measured sleep outcomes, use of health care resources and costs will also be evaluated.

Conditions

• Organ Transplant

Interventions

BEHAVIORAL

Mindfulness-Based Stress Reduction (MSBR)

Mindfulness-Based Stress Reduction (MBSR) is the intervention of primary interest. It is a psycho-educational program of 8-weekly classes, 2.5 hours long taught by a trained instructor. Over the course of the program participants receive training in several formal meditation techniques: a body-scan meditation, sitting meditation, walking meditation and mindful Hatha yoga that involves simple stretches and movements. Participants are requested to practice meditation at home and to integrate informal mindfulness practices into their daily lives. The content of MBSR is described in the book Full Catastrophe Living by Jon Kabat-Zinn.

BEHAVIORAL

Health Education (HE)

The active control condition was a peer-led chronic disease self-management program comprised of 8 weekly, 2.5 hour meetings. Led by trained peer-leaders, groups of participants discussed health challenges and problem-solved using a technique called action-planning. The curriculum described by Lorig and colleagues in the book Living a Health Life was the core of this program, and transplant-specific issues were covered in two meetings to match MBSR for time and attention.

BEHAVIORAL

Delayed Intervention

A temporary wait-list control group; after 6 months, those in the Delayed Intervention were randomized a second time, to one of the active treatment arms (MBSR or HE).

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  lead NIH

Principal Investigators

• Dr. Cynthia Gross · University of Minnesota

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-08-31

Primary Completion

2008-05-31

Completion

2008-05-31

Countries

• United States

Study Locations