Journeys to Wellness: A Transplant Candidate Study
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2010 |
| End Date: | August 2015 |
Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083
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.
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.
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).
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).
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.
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