Trial Outcomes & Findings for Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion. (NCT NCT02746679)
NCT ID: NCT02746679
Last Updated: 2016-08-26
Results Overview
The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).
COMPLETED
NA
226 participants
Baseline and 8 weeks
2016-08-26
Participant Flow
Patients were recruited into present study between January 2015 and January 2016
A total of 226 patients with IUA were recruited into present study within 12 months. Of them, 10 met the exclusion criteria and 55 patients refused to participate in this study. Finally, 161 patients were randomized into MBSR group (n=80) and wait-list group (n=81).
Participant milestones
| Measure |
MBSR Group
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this
|
Wait-list Control Group
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
81
|
|
Overall Study
COMPLETED
|
76
|
75
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
MBSR Group
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this
|
Wait-list Control Group
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
Baseline Characteristics
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.
Baseline characteristics by cohort
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.7 years
STANDARD_DEVIATION 5.5 • n=113 Participants
|
31.1 years
STANDARD_DEVIATION 6.5 • n=163 Participants
|
30.9 years
STANDARD_DEVIATION 6.0 • n=160 Participants
|
|
Sex/Gender, Customized
female
|
76 participants
n=113 Participants
|
75 participants
n=163 Participants
|
151 participants
n=160 Participants
|
|
Education
≥9 years
|
71 participants
n=113 Participants
|
67 participants
n=163 Participants
|
138 participants
n=160 Participants
|
|
Education
< 9 years
|
5 participants
n=113 Participants
|
8 participants
n=163 Participants
|
13 participants
n=160 Participants
|
|
Marriage
Single
|
12 participants
n=113 Participants
|
7 participants
n=163 Participants
|
19 participants
n=160 Participants
|
|
Marriage
Married
|
64 participants
n=113 Participants
|
68 participants
n=163 Participants
|
132 participants
n=160 Participants
|
|
Salary per month
< ¥ 5000
|
16 participants
n=113 Participants
|
15 participants
n=163 Participants
|
31 participants
n=160 Participants
|
|
Salary per month
> ¥ 5000
|
60 participants
n=113 Participants
|
60 participants
n=163 Participants
|
120 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksThe full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
before intervention
|
36.4 units on a scale(raw scores)
Standard Deviation 6.2
|
37.3 units on a scale(raw scores)
Standard Deviation 6.8
|
|
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
after intervention
|
32.1 units on a scale(raw scores)
Standard Deviation 5.9
|
38.5 units on a scale(raw scores)
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
before intervention
|
4.4 mm
Standard Deviation 2.5
|
4.1 mm
Standard Deviation 2.4
|
|
Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
after intervention
|
5.7 mm
Standard Deviation 1.4
|
5.2 mm
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation
before intervention
|
43.9 units on a scale
Standard Deviation 22.5
|
44.8 units on a scale
Standard Deviation 27.8
|
|
Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation
after intervention
|
68.5 units on a scale
Standard Deviation 22.0
|
69.2 units on a scale
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery
Reformation of intrauterine adhesions
|
14 participants
|
26 participants
|
|
Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery
Normal uterine
|
62 participants
|
49 participants
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Zung Self-Rating Depression Scale Scores Before and After the Intervention
before intervention
|
40.3 units on a scale(raw scores)
Standard Deviation 7.2
|
39.7 units on a scale(raw scores)
Standard Deviation 6.2
|
|
The Zung Self-Rating Depression Scale Scores Before and After the Intervention
after intervention
|
37.1 units on a scale(raw scores)
Standard Deviation 7.4
|
40.9 units on a scale(raw scores)
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
86.5 units on a scale(t scores)
Standard Deviation 13.7
|
88.1 units on a scale(t scores)
Standard Deviation 12.5
|
|
The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
90.9 units on a scale(t scores)
Standard Deviation 10.7
|
85.3 units on a scale(t scores)
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
61.5 units on a scale(t scores)
Standard Deviation 38.2
|
60.3 units on a scale(t scores)
Standard Deviation 35.9
|
|
The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
74.7 units on a scale(t scores)
Standard Deviation 26.6
|
55.7 units on a scale(t scores)
Standard Deviation 34.3
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
55.7 units on a scale(t scores)
Standard Deviation 34.3
|
64.0 units on a scale(t scores)
Standard Deviation 35.0
|
|
The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
78.5 units on a scale(t scores)
Standard Deviation 22.9
|
62.7 units on a scale(t scores)
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
67.2 units on a scale(t scores)
Standard Deviation 19.5
|
64.5 units on a scale(t scores)
Standard Deviation 19.8
|
|
The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
74.9 units on a scale(t scores)
Standard Deviation 11.6
|
62.3 units on a scale(t scores)
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
64.6 units on a scale(t scores)
Standard Deviation 16.3
|
64.9 units on a scale(t scores)
Standard Deviation 16.8
|
|
The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
72.9 units on a scale(t scores)
Standard Deviation 13.0
|
63.9 units on a scale(t scores)
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
78.1 units on a scale(t scores)
Standard Deviation 19.6
|
80.3 units on a scale(t scores)
Standard Deviation 18.0
|
|
The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
86.2 units on a scale(t scores)
Standard Deviation 13.9
|
80.5 units on a scale(t scores)
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
71.3 units on a scale(t scores)
Standard Deviation 15.1
|
70.4 units on a scale(t scores)
Standard Deviation 16.3
|
|
The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
72.5 units on a scale(t scores)
Standard Deviation 11.1
|
68.5 units on a scale(t scores)
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksThe 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
Outcome measures
| Measure |
MBSR Group
n=76 Participants
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
|
Wait-list Control Group
n=75 Participants
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
|
|---|---|---|
|
The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
before intervention
|
56.9 units on a scale(t scores)
Standard Deviation 17.7
|
58.9 units on a scale(t scores)
Standard Deviation 19.0
|
|
The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
after intervention
|
66.5 units on a scale(t scores)
Standard Deviation 16.0
|
57.1 units on a scale(t scores)
Standard Deviation 17.6
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Adverse Events
MBSR Group
Wait-list Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yuqing Chen
The First Affiliated Hospital of Sun Yat-sen University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place