Mindfulness TrainingNCT06473636
Mindfulness Training Improves Emotions Among Female Abdominal Cancer Patients
A study testing Mindfulness training in people with Mindfulness Training, run by Zunyi Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Mindfulness Training
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with abdominal cancer; female; over 19 years old
Who cannot join
- a history of neurological or psychiatric illness; intellectual or speech disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Training Improves Depression Among Female Abdominal Cancer Patients Through Improving Cognitive Emotion Regulation and Emotional State
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 (n=30) who received a four-week mindfulness training program, and the control group (n=30) 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.
Read the detailed description
Participants Sixty patients with abdominal cancer from a hospital were recruited. All patients were divided into a mindfulness group (n=30) who received a four-week mindfulness training program and a control group (n=30) who received only one mindfulness lecture over four weeks. No age difference was found between the mindfulness group (M=53.87, SD=10.31, ranging from 35 to 75) and the control group (M=52.73, SD=7.27, ranging from 42 to 69), t(58) =0.49, p=0.625. 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 Cronbach\'s α was 0.89 and the two-week test-retest reliability was 0.87 in the Chinese sample. The Cronbach\'s α coefficient of the scale in the present study was 0.87.
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 Cronbach\'s α was 0.86 and the two-week test-retest reliability was 0.86 in the Chinese sample. The Cronbach\'s α coefficient of the scale in the present study was 0.87.
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 (\"strongly disagree\") to 5 (\"strongly agree\"). 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 Cronbach\'s α coefficients for these subscales ranged from 0.48 to 0.89. The Cronbach\'s α coefficients of the adaptive and non-adaptive cognitive emotion regulation strategies subscales in the present study were 0.84 and 0.74 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 Cronbach\'s α for positive and negative emotions were 0.85 and 0.83 respectively in the Chinese sample. The Cronbach\'s α coefficients of the positive and negative emotions subscales in the present study were 0.84 and 0.78 respectively.
Procedure There are three phases in the present study, i.e., 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-Zinn\'s Mindfulness-Based Stress Reduction5 and Williams\' 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 (i.e., improvement=T2-T1). Next, we examined bivariate correlations between each two improvements. Finally, we treated mindfulness training (0=control group, 1=training group) as the independent variable, the improvement in depressive symptoms as the dependent variable, and the improvements in cognitive emotion regulation strategy and positive/negative emotions as the mediators. We utilized the PROCESS v4.1 macro for SPSS (Model 6) to test the mediation effects.
- Conditions
- Mindfulness Training
- Being tested
- Mindfulness training
- Keywords
- mindfulness training; abdominal cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
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 mindfulness training program was based on Kabat-Zinn's Mindfulness-Based Stress Reduction and Williams' 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.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness group | Experimental | Received a four-week mindfulness training program. Receives: Behavioral: Mindfulness training |
| control group | No intervention | Received only one mindfulness lecture over four weeks. Following the completion of the study, the control group could also undergo the same mindfulness training program if they volunteered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline Mindful Attention Awareness Scale at post-training
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.
Measured: Baseline (Day 0)/Post-training (Month 1)
The change from baseline Patient Health Questionnaire at post-training
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.
Measured: Baseline (Day 0)/Post-training (Month 1)
The change from baseline Cognitive Emotion Regulation Questionnaire at post-training
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 ("strongly disagree") to 5 ("strongly agree"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events.
Measured: Baseline (Day 0)/Post-training (Month 1)
The change from baseline Positive and Negative Affect Scale at post-training
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.
Measured: Baseline (Day 0)/Post-training (Month 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Aug 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kou Hui, Zunyi Medical College
- Investigators
- Taiyong Bi, PhD, Study director, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473636
- Sponsor's protocol ID
- ZunyiMP
- Status last verified
- May 2025
- First submitted
- 19 Jun 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training Improves Depression Among Female Abdominal Cancer Patients Through Improving Cognitive Emotion Regulation and Emotional State
- ClinicalTrials.gov ID
- NCT06473636
- Acronym / sponsor ID
- ZunyiMP
- Conditions
- Mindfulness Training
- Keywords
- mindfulness training; abdominal cancer patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (n=30) who received a four-week mindfulness training program, and the control group (n=30) 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 (n=30) who received a four-week mindfulness training program and a control group (n=30) who received only one mindfulness lecture over four weeks. No age difference was found between the mindfulness group (M=53.87, SD=10.31, ranging from 35 to 75) and the control group (M=52.73, SD=7.27, ranging from 42 to 69), t(58) =0.49, p=0.625. 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 Cronbach\'s α was 0.89 and the two-week test-retest reliability was 0.87 in the Chinese sample. The Cronbach\'s α coefficient of the scale in the present study was 0.87.
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 Cronbach\'s α was 0.86 and the two-week test-retest reliability was 0.86 in the Chinese sample. The Cronbach\'s α coefficient of the scale in the present study was 0.87.
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 (\"strongly disagree\") to 5 (\"strongly agree\"). 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 Cronbach\'s α coefficients for these subscales ranged from 0.48 to 0.89. The Cronbach\'s α coefficients of the adaptive and non-adaptive cognitive emotion regulation strategies subscales in the present study were 0.84 and 0.74 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 Cronbach\'s α for positive and negative emotions were 0.85 and 0.83 respectively in the Chinese sample. The Cronbach\'s α coefficients of the positive and negative emotions subscales in the present study were 0.84 and 0.78 respectively.
Procedure There are three phases in the present study, i.e., 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-Zinn\'s Mindfulness-Based Stress Reduction5 and Williams\' 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 (i.e., improvement=T2-T1). Next, we examined bivariate correlations between each two improvements. Finally, we treated mindfulness training (0=control group, 1=training group) as the independent variable, the improvement in depressive symptoms as the dependent variable, and the improvements in cognitive emotion regulation strategy and positive/negative emotions as the mediators. We utilized the PROCESS v4.1 macro for SPSS (Model 6) to test the mediation effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness group | Experimental | Behavioral: Mindfulness trainingReceived a four-week mindfulness training program. |
| control group | No intervention | –Received only one mindfulness lecture over four weeks. Following the completion of the study, the control group could also undergo the same mindfulness training program if they volunteered. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with abdominal cancer; female; over 19 years old
Key exclusion criteria (1 listed)
- a history of neurological or psychiatric illness; intellectual or speech disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingThe 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 mindfulness training program was based on Kabat-Zinn's Mindfulness-Based Stress Reduction and Williams' 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. | Behavioural | mindfulness group |
Primary outcome
The change from baseline Mindful Attention Awareness Scale at post-training
Time frame: Baseline (Day 0)/Post-training (Month 1)
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 change from baseline Patient Health Questionnaire at post-training
Time frame: Baseline (Day 0)/Post-training (Month 1)
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 change from baseline Cognitive Emotion Regulation Questionnaire at post-training
Time frame: Baseline (Day 0)/Post-training (Month 1)
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 ("strongly disagree") to 5 ("strongly agree"). Higher scores on each subscale indicate a greater likelihood of utilizing that particular cognitive emotion regulation strategy in the face of negative events.
The change from baseline Positive and Negative Affect Scale at post-training
Time frame: Baseline (Day 0)/Post-training (Month 1)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taiyong Bi, PhD study director
Zunyi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training in people with Mindfulness Training, run by Zunyi Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline Mindful Attention Awareness Scale at post-training (time frame: Baseline (Day 0)/Post-training (Month 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.