Journeys to Wellness: A Transplant Candidate Study

End-stage Renal Disease Clinical Trial

Official title:

Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254214
• Other study ID #: 0907S70361
• Secondary ID: 2P01DK013083
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2010
• Last updated: September 17, 2015
• Start date: February 2010
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.

Description:

Primary Aims

1. Test the efficacy of a telephone-adapted Mindfulness-Based Stress Reduction (tMBSR) program to reduce symptoms and improve the quality of life of kidney transplant candidates by 8-weeks and by 6-month follow-up.

2. Evaluate the impact of tMBSR on sleep measured by actigraphy, and on physiologic stress, as indicated by alteration in the slope of diurnal salivary cortisols, measured before and at the end of the 8-week active intervention period.

Secondary Aims

1. Evaluate the impact of tMBSR on perceptions of transplant surgery (treatment satisfaction, pain) and of Health Related Quality of Life (HRQL) at 2-, 6- and 12-mos post-transplant surgery.

2. Design a full-scale randomized controlled trial (RCT) of the effectiveness and cost-effectiveness of tMBSR.

Hypotheses

• Primary: The tMBSR group will report better outcomes than an attention control support group (SG) on standardized scales for anxiety, depression, and sleep quality and health-related quality of life at 8 weeks and 6 month follow-up.

• Secondary: The tMBSR group will report better outcomes than the SG group on actigraphy-derived sleep parameters and diurnal salivary cortisol patterns.

• Tertiary: Candidates who attended mindfulness training will report greater treatment satisfaction, less distress from pain with transplant surgery and better HRQL 2 months, 6 months and 1 year after kidney transplantation.

Rationale for study : For patients with living with kidney failure, the wait for new kidney is a stressful time. Pharmacologic therapies for managing symptoms of stress increase risks for side effects and non-adherence. Mindfulness-based stress reduction (MBSR), a non-pharmacologic program of training in mindfulness meditation, could help these patients reduce their symptom distress without increasing these other risks.

Long-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide symptom relief to transplant patients, and are safe, practical and cost-effective.

Interventions: The tMBSR program includes the curricular content of the standard 8-week MBSR program (2002 Instructor's Manual). A trained teacher provides instruction in meditation techniques including the body-scan, standing, sitting and walking meditations, and gentle Hatha yoga. Whereas the standard MBSR is conducted as 8 weekly 2.5 hour classes with a one day retreat between weeks 6 and 7, the telephone-adapted MBSR program begins with 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8. Home practice expectations are 25 minutes per day, 6 days a week for tMBSR.

The attention control consists of two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support.

Recruiting Methods:

1. Direct mail to candidates being followed by the Transplant Information Services Office with follow-up calls; invitation letters and brochures sent from the P01 Clinical Core.

2. Posters and flyers in medical clinics.

3. Referral by health providers - in- service presentations to the pre-transplant coordinators who manage the kidney candidates;

4. Additional invitations letters mailed by the coordinator who maintains the waitlist for the United Network for Organ Sharing (UNOS); study brochure or invitation letters mailed with waitlist acceptance letters.

Potential Measures of intervention 'dose' or enactment:

1. Mindfulness scale: Mindful Awareness Attention Scale (MAAS);

2. Meditation practice time.

Exploratory Outcomes: Post-transplant impact on Quality of Life (QOL) by Short-Form-36 item(SF-36), pain and satisfaction with transplant hospitalization.

Evaluation Methods:

1. Self-report, mailed questionnaires completed at study weeks 0, 8, 26 (primary outcomes and QOL measures),

2. Actigraphy recording for 1 week prior to the intervention and during the last week of the intervention; cortisol collection for 3 days during same time periods.

3. Post transplant evaluations - 2 and 6 mos; 1 year coordinated with Transplant Database

Duration of Treatment: 8 weeks

Study Duration: Participants are followed up to one year post-kidney transplant.

Statistical Considerations: This study is powered to compare MBSR and SG, on the primary endpoint, on the State Trait Anxiety Inventory (STAI), at 8 weeks. Randomization may be stratified by dialysis (yes/no) and history of diabetes (yes/no).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Candidate on the United Network for Organ Sharing (UNOS) wait list for a kidney or kidney-pancreas or evaluated as eligible for candidacy at the UMN

• Aged 18 or older

• English-speaking

• Literate

• Mentally intact

• Able to use the telephone to participate in 6 weekly teleconferences

• Able to attend 2 in-person classes in a Minnesota Metro area

• Able to comply with study monitoring requirements

• Receiving standard medical follow-up care

• Willing to complete the informed consent process

Exclusion Criteria:

• Prior transplant

• Medically unstable (a hospital admission for non-elective purposes in the last 3 months or major non-transplant surgery planned in the next 3 months)

• Serious preexisting mental health issues: suicidality or thought disorder/psychosis; or delirium or substance abuse

• Not expected to be on the waiting list > 3 months (e.g., acceptable living donor has been identified and scheduled)

• Prior MBSR class or regularly practicing mindfulness meditation (twice a week or more)

• Not receiving standard medical care.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• tMBSR
MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8.
• Support group
The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View Citation

Kreitzer MJ, Gross CR, Waleekhachonloet OA, Reilly-Spong M, Byrd M. The brief serenity scale: a psychometric analysis of a measure of spirituality and well-being. J Holist Nurs. 2009 Mar;27(1):7-16. doi: 10.1177/0898010108327212. Epub 2009 Jan 28. — 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	State-Trait Anxiety Inventory	self-reported anxiety symptoms	8 and 26 weeks	No
Secondary	Short Form -12	Measure self-perceived mental and physical health status	6 and 26 weeks	No
Secondary	Pittsburgh Sleep Quality Index (PSQI)	A measure of self-reported sleep quality over the past month	8 and 26 weeks	No
Secondary	Center for Epidemiologic Studies Depression Scale (CESD)	A self-reported measure of symptoms of depression	8 and 26 weeks	No