Skip to main content
OpenTrials
Completed

NCT Number: NCT00367809

Wellness Interventions After Transplant Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Organ Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Minnesota Academic Health Center

Minneapolis, Minnesota, 55404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction (MSBR)

Behavioral

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.

Health Education (HE)

Behavioral

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.

Delayed Intervention

Behavioral

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).

Primary outcomes

  1. Reduction in depression

    Time frame: Baseline; at 8 weeks, at 6- and 12- months

  2. anxiety

    Time frame: Baseline; at 8 weeks, at 6- and 12- months

  3. insomnia

    Time frame: Baseline; at 8 weeks, at 6- and 12- months

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Official study title

Impact of Mind-Body Interventions Post Organ Transplant

Acronym: WIAT

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Aug 23, 2006
Registry last updated
Sep 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.