WIAT: Wellness Interventions After Transplant Study

Sponsor

National Institute of Nursing Research (NINR) (NIH)

Overall Status

Completed

CT.gov ID

NCT00367809

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

Impact of Mind-Body Interventions Post Organ Transplant

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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).

Arm

Intervention/Treatment

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).

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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