Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion. (IMBSRADQWIUA)

• ClinicalTrials.gov Identifier: NCT02746679
• Recruitment Status: Completed
• First Posted: April 21, 2016
• Results First Posted: August 26, 2016
• Last Update Posted: August 26, 2016
• Sponsor: Yuqing Chen
• Information provided by (Responsible Party): Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Study Description

Brief Summary:

The purpose of this study is to determine whether mindfulness based stress reduction are effective on improve anxiety, depression and quality of life in women with intrauterine adhesion

Condition or disease	Intervention/treatment	Phase
Asherman Syndrome	Other: Mindfulness Based Stress Reduction	Not Applicable

Detailed Description:

This is a parallel arm, randomized controlled trials, according to 1: 1 ratio assigned intrauterine adhesions patients to mindfulness based stress reduction group and wait-list control group.The study compared anxiety and depression levels and quality of life in patients with intrauterine adhesions before and after the completion of mindfulness based stress reduction program.Anxiety, depression and quality of life level measured by the Zung self-rating anxiety scale, Zung Self-Rating Depression Scale and The 36-item Short-Form Health Survey.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 226 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and Quality of Life in Women With Intrauterine Adhesion:a Randomized Controlled Trial.
• Study Start Date: January 2015
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: 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 study was to examine whether MBSR is effective, and has potential as an intervention to decrease depression, anxiety ,and to improve quality of life of intrauterine adhesion patients.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention [ Time Frame: Baseline and 8 weeks ]
   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).

Secondary Outcome Measures :

1. Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. [ Time Frame: 3 months ]
2. 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 [ Time Frame: 3 months ]
3. Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery [ Time Frame: 3 months ]
4. The Zung Self-Rating Depression Scale Scores Before and After the Intervention [ Time Frame: Baseline and 8 weeks ]
   The 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).
5. The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
   The 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.
6. The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
   The 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.
7. The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
   The 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.
8. The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
   The 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.
9. The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
   The 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.
10. The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 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.
11. The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 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.
12. The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 46 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Meet intrauterine adhesions diagnostic criteria of ESGE.
2. Patients with clear consciousness, can correct understanding related content of the questionnaire.

Exclusion Criteria:

1. Have a history of mental illness.
2. Receiving psychological treatment currently.
3. Have acute mental disorders.
4. Experienced special stress life events within six months.

Contacts and Locations

Sponsors and Collaborators

Yuqing Chen

Investigators

• Study Chair: Shuzhong Yao, professor; First Affiliated Hospital, Sun Yat-Sen University

More Information

Publications:

Roth B, Robbins D. Mindfulness-based stress reduction and health-related quality of life: findings from a bilingual inner-city patient population. Psychosom Med. 2004 Jan-Feb;66(1):113-23.

Würtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19.

• Responsible Party: Yuqing Chen, associate professor, First Affiliated Hospital, Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT02746679 History of Changes
• Other Study ID Numbers: MBSR-5
• First Posted: April 21, 2016
• Results First Posted: August 26, 2016
• Last Update Posted: August 26, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University:

Asherman syndrome; Mindfulness; Anxiety; Depression; Quality of Life

Additional relevant MeSH terms:

Gynatresia; Depression; Behavioral Symptoms; Genital Diseases, Female