Clinical trial NCT00367809: Wellness Interventions After Transplant Study
Official title: Impact of Mind-Body Interventions Post Organ Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Organ Transplant
Keywords: Meditation
Mindfulness
Organ Transplant
Transplantation
Minnesota
Immune suppressive therapy
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2006-08-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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 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

Primary outcomes:
measure: Reduction in depression
timeFrame: Baseline; at 8 weeks, at 6- and 12- months
measure: anxiety
timeFrame: Baseline; at 8 weeks, at 6- and 12- months
measure: insomnia
timeFrame: Baseline; at 8 weeks, at 6- and 12- months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Academic Health Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dr. Cynthia Gross
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.