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Journeys to Wellness: A Transplant Candidate Study

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 13, 2016
Last verified: September 2016
Results First Received: June 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: End-stage Renal Disease
Interventions: Behavioral: tMBSR
Behavioral: Support group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
66 people were screened, 3 were ineligible, and of the 63 who consented only 55 actually participated in the trial.

Reporting Groups
  Description
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.

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 Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support

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.


Participant Flow:   Overall Study
    tMBSR   Support Group
STARTED   27   28 
COMPLETED   24   27 
NOT COMPLETED   3   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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 Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support

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.

Total Total of all reporting groups

Baseline Measures
   tMBSR   Support Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   28   55 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   23   46 
>=65 years   4   5   9 
Gender 
[Units: Participants]
     
Female   19   12   31 
Male   8   16   24 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   3   4 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   6   2   8 
White   19   23   42 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   27   28   55 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   State-Trait Anxiety Inventory   [ Time Frame: Baseline, 8 weeks, 26 weeks ]

2.  Secondary:   Short Form -12 MCS   [ Time Frame: baseline, 8 and 26 weeks ]

3.  Secondary:   SF-12 PCS   [ Time Frame: baseline, 8 weeks, 26 weeks ]

4.  Secondary:   Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: baseline, 8 weeks, 26 weeks ]

5.  Secondary:   Center for Epidemiologic Studies Depression Scale (CESD)   [ Time Frame: baseline, 8 weeks, 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cynthia Gross PhD
Organization: University of Minnesota
phone: 612-624-8676
e-mail: gross002@umn.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01254214     History of Changes
Other Study ID Numbers: 0907S70361
2P01DK013083 ( US NIH Grant/Contract Award Number )
Study First Received: September 27, 2010
Results First Received: June 21, 2016
Last Updated: September 13, 2016
Health Authority: United States: Institutional Review Board