Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473636
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Mindfulness Training Improves Emotions Among Female Abdominal Cancer Patients
Sponsor:
Zunyi Medical College
Organization:
Zunyi Medical College
Study Overview
Official Title:
Mindfulness Training Improves Depression Among Female Abdominal Cancer Patients Through Improving Cognitive Emotion Regulation and Emotional State
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We first explored the effect of mindfulness training on depression in patients with abdominal cancer Then the effects of cognitive emotion regulation and emotional state in the training effect were examined Sixty patients with abdominal cancer were recruited from a hospital and divided into two groups the mindfulness group n30 who received a four-week mindfulness training program and the control group n30 who received only one mindfulness lecture All participants were assessed using the Mindful Attention Awareness Scale Cognitive Emotion Regulation Strategy Questionnaire Positive and Negative Affect Scale and depression subscale of the Patient Health Questionnaire before and after the mindfulness training program
Detailed Description:
Participants Sixty patients with abdominal cancer from a hospital were recruited All patients were divided into a mindfulness group n30 who received a four-week mindfulness training program and a control group n30 who received only one mindfulness lecture over four weeks No age difference was found between the mindfulness group M5387 SD1031 ranging from 35 to 75 and the control group M5273 SD727 ranging from 42 to 69 t58 049 p0625 The participants were all women and none of them reported a history of neurological or psychiatric illness
Ethics approval statement All procedures involving human participants in this study were conducted in strict accordance with the ethical standards of the Ethical Committee at a medical university as well as the 1964 Helsinki Declaration and its subsequent amendments or any comparable ethical standards All participants gave informed consent before participating Furthermore following the completion of the study the control group could also undergo the same mindfulness training program if they volunteered
Measurements Mindful Attention Awareness Scale It contains 15 items in a single dimension All of the items are rated on a 7-point Likert scale from 1 strongly agree to 7 strongly disagree Higher scores reflect a higher level of trait mindfulness and awareness of the present moment The Cronbach39s α was 089 and the two-week test-retest reliability was 087 in the Chinese sample The Cronbach39s α coefficient of the scale in the present study was 087
The Patient Health Questionnaire Its depression subscale consists of 9 items All of the items are rated on a 4-point Likert scale from 1 strongly disagree to 4 strongly agree Higher scores indicate a greater level of depression The Cronbach39s α was 086 and the two-week test-retest reliability was 086 in the Chinese sample The Cronbach39s α coefficient of the scale in the present study was 087
The Cognitive Emotion Regulation Questionnaire It consists of 36 items and nine subscales These subscales assess various strategies employed in cognitive emotion regulation such as self-blame blaming others acceptance refocus on planning positive refocusing rumination or focus on thought positive reappraisal putting into perspective and catastrophizing Each item is rated on a 5-point Likert scale ranging from 1 34strongly disagree34 to 5 34strongly agree34 Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events Adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the acceptance putting into perspective refocus on planning positive refocusing and positive reappraisal subscales Non-adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the self-blame blaming others rumination or focus on thought and catastrophizing subscales In the Chinese samples the Cronbach39s α coefficients for these subscales ranged from 048 to 089 The Cronbach39s α coefficients of the adaptive and non-adaptive cognitive emotion regulation strategies subscales in the present study were 084 and 074 respectively
The Positive and Negative Affect Scale It contains 20 items and consists of two self-report subscales including positive emotions and negative emotions All of the items are rated on a 5-point Likert scale from 1 strongly disagree to 5 strongly agree The higher the score the stronger the emotions in a certain dimension The Cronbach39s α for positive and negative emotions were 085 and 083 respectively in the Chinese sample The Cronbach39s α coefficients of the positive and negative emotions subscales in the present study were 084 and 078 respectively
Procedure There are three phases in the present study ie the pre-training test phase T1 the training phase and the post-training test phase T2 In the two test phases all participants completed all the questionnaires including the Mindful Attention Awareness Scale the Patient Health Questionnaire-depression subscale the Cognitive Emotion Regulation Questionnaire and the Positive and Negative Affect Scales
The mindfulness training program consisted of four 45-minute lessons conducted once a week After each lesson participants were required to complete daily homework which included the mindfulness exercises learned during that week for at least 30 minutes The control group only attended a mindfulness lecture during the four weeks
The mindfulness training program was based on Kabat-Zinn39s Mindfulness-Based Stress Reduction5 and Williams39 Mindfulness-Based Cognitive Therapy Additionally specific contents of cancer-related mindfulness training were incorporated into this program such as Anti-cancer Self-healing Power 8 Lessons in Mindfulness-based Stress Reduction The contents of the mindfulness training program included
Session 1 Establishing a connection with the body Mindfulness activities consisted of eating one raisin mindfully and mindfulness cobble practice
Session 2 Observing thoughts as they are Mindfulness activities included the body scan and awareness of breathing meditation
Session 3 Cultivating mindful attention Mindfulness activities involved awareness of breathing meditation and mindfulness compassion meditation
Session 4 Applying mindfulness in daily life Mindfulness activities included embracing yourself 3-min breathing space and mindfulness stretching exercises
Statistical analysis To investigate the impact of mindfulness training on mental states we conducted a 2 Group mindfulness group and control group 2 Test time T1 and T2 repeated measures ANOVA on each scale score If a significant interaction effect or main effect was observed post hoc analysis with Bonferroni correction was performed To examine the role of cognitive emotion regulation strategy in improving emotional symptoms we constructed multiple mediation models based on previous studies First we calculated the improvements in all measurements by subtracting the scores at T1 from the scores at T2 ie improvementT2-T1 Next we examined bivariate correlations between each two improvements Finally we treated mindfulness training 0control group 1training group as the independent variable the improvement in depressive symptoms as the dependent variable and the improvements in cognitive emotion regulation strategy and positivenegative emotions as the mediators We utilized the PROCESS v41 macro for SPSS Model 6 to test the mediation effects
Ethics approval statement All procedures involving human participants in this study were conducted in strict accordance with the ethical standards of the Ethical Committee at a medical university as well as the 1964 Helsinki Declaration and its subsequent amendments or any comparable ethical standards All participants gave informed consent before participating Furthermore following the completion of the study the control group could also undergo the same mindfulness training program if they volunteered
Measurements Mindful Attention Awareness Scale It contains 15 items in a single dimension All of the items are rated on a 7-point Likert scale from 1 strongly agree to 7 strongly disagree Higher scores reflect a higher level of trait mindfulness and awareness of the present moment The Cronbach39s α was 089 and the two-week test-retest reliability was 087 in the Chinese sample The Cronbach39s α coefficient of the scale in the present study was 087
The Patient Health Questionnaire Its depression subscale consists of 9 items All of the items are rated on a 4-point Likert scale from 1 strongly disagree to 4 strongly agree Higher scores indicate a greater level of depression The Cronbach39s α was 086 and the two-week test-retest reliability was 086 in the Chinese sample The Cronbach39s α coefficient of the scale in the present study was 087
The Cognitive Emotion Regulation Questionnaire It consists of 36 items and nine subscales These subscales assess various strategies employed in cognitive emotion regulation such as self-blame blaming others acceptance refocus on planning positive refocusing rumination or focus on thought positive reappraisal putting into perspective and catastrophizing Each item is rated on a 5-point Likert scale ranging from 1 34strongly disagree34 to 5 34strongly agree34 Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events Adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the acceptance putting into perspective refocus on planning positive refocusing and positive reappraisal subscales Non-adaptive cognitive emotion regulation strategy is assessed using the sum of scores on the self-blame blaming others rumination or focus on thought and catastrophizing subscales In the Chinese samples the Cronbach39s α coefficients for these subscales ranged from 048 to 089 The Cronbach39s α coefficients of the adaptive and non-adaptive cognitive emotion regulation strategies subscales in the present study were 084 and 074 respectively
The Positive and Negative Affect Scale It contains 20 items and consists of two self-report subscales including positive emotions and negative emotions All of the items are rated on a 5-point Likert scale from 1 strongly disagree to 5 strongly agree The higher the score the stronger the emotions in a certain dimension The Cronbach39s α for positive and negative emotions were 085 and 083 respectively in the Chinese sample The Cronbach39s α coefficients of the positive and negative emotions subscales in the present study were 084 and 078 respectively
Procedure There are three phases in the present study ie the pre-training test phase T1 the training phase and the post-training test phase T2 In the two test phases all participants completed all the questionnaires including the Mindful Attention Awareness Scale the Patient Health Questionnaire-depression subscale the Cognitive Emotion Regulation Questionnaire and the Positive and Negative Affect Scales
The mindfulness training program consisted of four 45-minute lessons conducted once a week After each lesson participants were required to complete daily homework which included the mindfulness exercises learned during that week for at least 30 minutes The control group only attended a mindfulness lecture during the four weeks
The mindfulness training program was based on Kabat-Zinn39s Mindfulness-Based Stress Reduction5 and Williams39 Mindfulness-Based Cognitive Therapy Additionally specific contents of cancer-related mindfulness training were incorporated into this program such as Anti-cancer Self-healing Power 8 Lessons in Mindfulness-based Stress Reduction The contents of the mindfulness training program included
Session 1 Establishing a connection with the body Mindfulness activities consisted of eating one raisin mindfully and mindfulness cobble practice
Session 2 Observing thoughts as they are Mindfulness activities included the body scan and awareness of breathing meditation
Session 3 Cultivating mindful attention Mindfulness activities involved awareness of breathing meditation and mindfulness compassion meditation
Session 4 Applying mindfulness in daily life Mindfulness activities included embracing yourself 3-min breathing space and mindfulness stretching exercises
Statistical analysis To investigate the impact of mindfulness training on mental states we conducted a 2 Group mindfulness group and control group 2 Test time T1 and T2 repeated measures ANOVA on each scale score If a significant interaction effect or main effect was observed post hoc analysis with Bonferroni correction was performed To examine the role of cognitive emotion regulation strategy in improving emotional symptoms we constructed multiple mediation models based on previous studies First we calculated the improvements in all measurements by subtracting the scores at T1 from the scores at T2 ie improvementT2-T1 Next we examined bivariate correlations between each two improvements Finally we treated mindfulness training 0control group 1training group as the independent variable the improvement in depressive symptoms as the dependent variable and the improvements in cognitive emotion regulation strategy and positivenegative emotions as the mediators We utilized the PROCESS v41 macro for SPSS Model 6 to test the mediation effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None