Trial Outcomes & Findings for Journeys to Wellness: A Transplant Candidate Study (NCT NCT01254214)
NCT ID: NCT01254214
Last Updated: 2016-10-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
63 participants
Primary outcome timeframe
Baseline, 8 weeks, 26 weeks
Results posted on
2016-10-31
Participant Flow
66 people were screened, 3 were ineligible, and of the 63 who consented only 55 actually participated in the trial.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
28
|
|
Overall Study
COMPLETED
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Journeys to Wellness: A Transplant Candidate Study
Baseline characteristics by cohort
| Measure |
tMBSR
n=27 Participants
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
n=28 Participants
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
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks, 26 weeksThe 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.
Outcome measures
| Measure |
tMBSR
n=24 Participants
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
n=27 Participants
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.
|
|---|---|---|
|
State-Trait Anxiety Inventory
8 weeks
|
40.6 units on a scale
Standard Deviation 15.0
|
34.8 units on a scale
Standard Deviation 10.0
|
|
State-Trait Anxiety Inventory
Baseline
|
42.1 units on a scale
Standard Deviation 12.7
|
37.8 units on a scale
Standard Deviation 12.7
|
|
State-Trait Anxiety Inventory
26 weeks
|
41.2 units on a scale
Standard Deviation 15.3
|
38.1 units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: baseline, 8 and 26 weeksMental 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.
Outcome measures
| Measure |
tMBSR
n=24 Participants
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
n=27 Participants
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.
|
|---|---|---|
|
Short Form -12 MCS
baseline
|
48.9 T-Scores
Standard Deviation 8.6
|
49.6 T-Scores
Standard Deviation 7.7
|
|
Short Form -12 MCS
8 week
|
48.3 T-Scores
Standard Deviation 8.4
|
51.1 T-Scores
Standard Deviation 7.2
|
|
Short Form -12 MCS
26 week
|
49.7 T-Scores
Standard Deviation 9.9
|
46.7 T-Scores
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: baseline, 8 weeks, 26 weeksPhysical 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.
Outcome measures
| Measure |
tMBSR
n=24 Participants
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
n=27 Participants
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.
|
|---|---|---|
|
SF-12 PCS
baseline
|
34.5 T scores
Standard Deviation 11.0
|
38.1 T scores
Standard Deviation 11.0
|
|
SF-12 PCS
8 week
|
38.1 T scores
Standard Deviation 10.5
|
38.3 T scores
Standard Deviation 11.3
|
|
SF-12 PCS
26 week
|
33.2 T scores
Standard Deviation 9.8
|
38.5 T scores
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: baseline, 8 weeks, 26 weeksThe 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.
Outcome measures
| Measure |
tMBSR
n=24 Participants
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
n=27 Participants
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.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
baseline
|
7.4 units on a scale
Standard Deviation 3.6
|
6.3 units on a scale
Standard Deviation 3.7
|
|
Pittsburgh Sleep Quality Index (PSQI)
8 week
|
7.3 units on a scale
Standard Deviation 4.7
|
6.1 units on a scale
Standard Deviation 3.4
|
|
Pittsburgh Sleep Quality Index (PSQI)
26 week
|
8.5 units on a scale
Standard Deviation 5.4
|
7.1 units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: baseline, 8 weeks, 26 weeksThe 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.
Outcome measures
| Measure |
tMBSR
n=24 Participants
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
n=27 Participants
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.
|
|---|---|---|
|
Center for Epidemiologic Studies Depression Scale (CESD)
baseline
|
15.4 units on a scale
Standard Deviation 9.9
|
11.1 units on a scale
Standard Deviation 7.5
|
|
Center for Epidemiologic Studies Depression Scale (CESD)
8 week
|
14.7 units on a scale
Standard Deviation 9.4
|
9.1 units on a scale
Standard Deviation 5.8
|
|
Center for Epidemiologic Studies Depression Scale (CESD)
26 week
|
16.9 units on a scale
Standard Deviation 11.6
|
11.1 units on a scale
Standard Deviation 8.6
|
Adverse Events
tMBSR
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Support Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place