Wellness Interventions After Transplant Study

Organ Transplant Clinical Trial

— WIAT  

Official title:

Impact of Mind-Body Interventions Post Organ Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367809
• Other study ID #: GCRC Protocol 942
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2006
• Last updated: September 12, 2008
• Start date: August 2003
• Est. completion date: May 2008

Study information

• Verified date: September 2008
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Organ Transplant

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	University of Minnesota Academic Health Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in depression		Baseline; at 8 weeks, at 6- and 12- months	No
Primary	anxiety		Baseline; at 8 weeks, at 6- and 12- months	No
Primary	insomnia		Baseline; at 8 weeks, at 6- and 12- months	No