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Journeys to Wellness: A Transplant Candidate Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01254214
First received: September 27, 2010
Last updated: September 2, 2014
Last verified: September 2014

September 27, 2010
September 2, 2014
February 2010
June 2014   (final data collection date for primary outcome measure)
State-Trait Anxiety Inventory [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]
self-reported anxiety symptoms
Same as current
Complete list of historical versions of study NCT01254214 on ClinicalTrials.gov Archive Site
  • Short Form -12 [ Time Frame: 6 and 26 weeks ] [ Designated as safety issue: No ]
    Measure self-perceived mental and physical health status
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]
    A measure of self-reported sleep quality over the past month
  • Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 8 and 26 weeks ] [ Designated as safety issue: No ]
    A self-reported measure of symptoms of depression
  • Short Form -12 [ Time Frame: 6 and 26 weeks ] [ Designated as safety issue: No ]
    Measure self-perceived mental and physical health status
  • Actigraphy [ Time Frame: 0 and 7 weeks ] [ Designated as safety issue: No ]
    Sleep parameters derived from actigraphs which are motion-detectors worn like a wrist watch for up to 7 nights.
  • Diurnal cortisol slope [ Time Frame: 0 and 7 weeks ] [ Designated as safety issue: No ]
    3 daily saliva samples will be collected for 3 days at pre-intervention baseline and again during the last week of the active intervention.
  • Perceived Stress Scale [ Time Frame: 6 and 26 weeks ] [ Designated as safety issue: No ]
    Measure self-perceived stress
  • PROMIS Fatigue Short Form [ Time Frame: 6 and 26 weeks ] [ Designated as safety issue: No ]
    Measure self-perceived fatigue
Not Provided
Not Provided
 
Journeys to Wellness: A Transplant Candidate Study
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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
End-stage Renal Disease
  • 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.
    Other Name: None applicable
  • Behavioral: 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.
  • Experimental: 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.
    Intervention: Behavioral: tMBSR
  • Active Comparator: 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
    Intervention: Behavioral: Support group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
August 2015
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254214
0907S70361, 2P01DK013083
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Cynthia R Gross, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP