Wellness Interventions After Transplant Study (WIAT)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00367809
First received: August 21, 2006
Last updated: September 12, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Organ Transplant
Behavioral: Mindfulness-Based Stress Reduction (MSBR)
Behavioral: Health Education (HE)
Behavioral: Delayed Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Mind-Body Interventions Post Organ Transplant

Resource links provided by NLM:


Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Reduction in depression [ Time Frame: Baseline; at 8 weeks, at 6- and 12- months ] [ Designated as safety issue: No ]
  • anxiety [ Time Frame: Baseline; at 8 weeks, at 6- and 12- months ] [ Designated as safety issue: No ]
  • insomnia [ Time Frame: Baseline; at 8 weeks, at 6- and 12- months ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: August 2003
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367809

Locations
United States, Minnesota
University of Minnesota Academic Health Center
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. Cynthia Gross University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia R. Gross, Professor, University of Minnesota, College of Pharmacy and School of Nursing
ClinicalTrials.gov Identifier: NCT00367809     History of Changes
Other Study ID Numbers: GCRC Protocol 942
Study First Received: August 21, 2006
Last Updated: September 12, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
Meditation
Mindfulness
Organ Transplant
Transplantation
Minnesota
Immune suppressive therapy

ClinicalTrials.gov processed this record on September 18, 2014