Wellness Interventions After Transplant Study

NCT00367809 | Completed Phase 3

• 1 other identifier: GCRC Protocol 942
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Organ Transplant

Keywords

Meditation; Mindfulness; Organ Transplant; Transplantation; Minnesota; Immune suppressive therapy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

1

EXPERIMENTAL

Behavioral: Mindfulness-Based Stress Reduction (MSBR)

2

ACTIVE COMPARATOR

Behavioral: Health Education (HE)

3

NO INTERVENTION

Behavioral: Delayed Intervention

Interventions

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.

1

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.

2

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).

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kidney, kidney/pancreas, pancreas, lung, liver, heart or heart-lung recipients, with a functioning graft
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

University of Minnesota Academic Health Center

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (4)

• 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.

  PMID: 15154154 BACKGROUND

• 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.

  PMID: 16013466 RESULT

• 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.

  PMID: 20882729 DERIVED

• 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.

  PMID: 19254938 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dr. Cynthia Gross

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 21, 2006
• First Posted: August 23, 2006
• Study Start: August 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 16, 2008

Record last verified: 2008-09

Locations

US (1)