Wellness Interventions After Transplant Study (WIAT)

Impact of Mind-Body Interventions Post Organ Transplant

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.

Study Overview

• Status: Completed
• Conditions: Organ Transplant
• Intervention / Treatment: Behavioral: Mindfulness-Based Stress Reduction (MSBR); Behavioral: Health Education (HE); Behavioral: Delayed Intervention

Detailed Description

Pharmacologic options for managing symptoms increase the risks of side effects and drug interactions, and may reduce adherence by complicating an already challenging medication regimen. In contrast, mind-body based complementary therapies may be ideal to treat distressing symptoms and negative emotions after transplantation. Our long-range objective is to develop evidence-based recommendations for non-pharmacologic strategies that provide symptom relief to transplant recipients, and are safe, practical and cost-effective.

Potential participants are recruited by mail, screening by clinic staff and provider referrals. Interested persons are screened by telephone and mailed informational study brochures. Informed consent is conducted by face-to-face interview, where a diagram of the study design is used to explain the 2-stage randomization and study requirements.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • University of Minnesota Academic Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• kidney, kidney/pancreas, pancreas, lung, liver, heart or heart-lung recipients, with a functioning graft
• 18 years old or older
• English-speaking
• literate
• mentally intact
• reachable by telephone
• on immune suppressive medication
• receiving regular medical follow-up care
• interested in health promotion and mind-body interventions
• able to attend weekly classes in a Minnesota Metro area
• willing to complete the informed consent process

Exclusion Criteria:

• serious preexisting mental health issues such as suicide attempts or a psychosis
• medically unstable (a hospital admission for non-elective purposes in the last 3 months or major surgery planned in the next 3 months)
• on dialysis
• regularly practicing mindfulness meditation

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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.
Active Comparator: 2	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.
No Intervention: 3	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in depression	Baseline; at 8 weeks, at 6- and 12- months
anxiety	Baseline; at 8 weeks, at 6- and 12- months
insomnia	Baseline; at 8 weeks, at 6- and 12- months

Collaborators and Investigators

• Sponsor: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Dr. Cynthia Gross, University of Minnesota

Publications and helpful links

General Publications

• Gross CR, Kreitzer MJ, Russas V, Treesak C, Frazier PA, Hertz MI. Mindfulness meditation to reduce symptoms after organ transplant: a pilot study. Altern Ther Health Med. 2004 May-Jun;10(3):58-66.
• Kreitzer MJ, Gross CR, Ye X, Russas V, Treesak C. Longitudinal impact of mindfulness meditation on illness burden in solid-organ transplant recipients. Prog Transplant. 2005 Jun;15(2):166-72. doi: 10.1177/152692480501500210.
• Gross CR, Kreitzer MJ, Thomas W, Reilly-Spong M, Cramer-Bornemann M, Nyman JA, Frazier P, Ibrahim HN. Mindfulness-based stress reduction for solid organ transplant recipients: a randomized controlled trial. Altern Ther Health Med. 2010 Sep-Oct;16(5):30-8.
• Gross CR, Kreitzer MJ, Reilly-Spong M, Winbush NY, Schomaker EK, Thomas W. Mindfulness meditation training to reduce symptom distress in transplant patients: rationale, design, and experience with a recycled waitlist. Clin Trials. 2009 Feb;6(1):76-89. doi: 10.1177/1740774508100982.

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 21, 2006
• First Submitted That Met QC Criteria: August 21, 2006
• First Posted (Estimate): August 23, 2006

Study Record Updates

• Last Update Posted (Estimate): September 16, 2008
• Last Update Submitted That Met QC Criteria: September 12, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Mindfulness; Meditation; Transplantation; Organ Transplant; Minnesota; Immune suppressive therapy
• Other Study ID Numbers: GCRC Protocol 942