Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367809
Status:
COMPLETED
Last Update Posted:
2008-09-16
First Post:
2006-08-21
Brief Title:
Wellness Interventions After Transplant Study
Sponsor:
National Institute of Nursing Research NINR
Organization:
National Institute of Nursing Research NINR
Study Overview
Official Title:
Impact of Mind-Body Interventions Post Organ Transplant
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WIAT
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None