Journeys to Wellness: A Transplant Candidate Study

Phase 3

Completed

Conditions: End-stage Renal Disease

Interventions: Behavioral: Support group
Behavioral: tMBSR

Registration Number: NCT01254214

Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Support Group	Support group	The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support
tMBSR	tMBSR	telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory	Baseline, 8 weeks, 26 weeks	The STAI is a 20 item scale that measures current anxiety symptoms with scores that range from 20 to 80, with higher scores indicating greater levels of anxiety. The norm for working adults is a score of 34.

Secondary Outcome Measures

Name	Time	Method
Short Form -12 MCS	baseline, 8 and 26 weeks	Mental component summary score (MCS) of the SF-12 is a self-reported measure of mental health-related quality of life. Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired mental health quality or function.
Pittsburgh Sleep Quality Index (PSQI)	baseline, 8 weeks, 26 weeks	The PSQI is a 19-item self-reported sleep quality measure with scores that range from 0 to 21, where higher scores indicate worse sleep quality. Scores greater than 5 indicate poor sleep.
Center for Epidemiologic Studies Depression Scale (CESD)	baseline, 8 weeks, 26 weeks	The CES-D is a 20-item self-report scale to measure symptoms of depression in the past week with scores having a range of 0 to 60 and a score of 16 or higher indicating clinically relevant symptoms.
SF-12 PCS	baseline, 8 weeks, 26 weeks	Physical component summary score (PCS) of the SF-12 is a self-reported measure of physical health-related quality of life.Scores are reported as standardized T-scores, where an average (mean) score in the general population is 50 with a standard deviation of 10. Scores of 40 or less indicate impaired physical health quality or function.