MDDNCT04071886
Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
A study testing Mindfulness-Based Training and Relaxation Training in people with MDD, run by Central South University at 1 site in China.
Trial summary
The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- MDD
- What is being tested?
- Mindfulness-Based Training and Relaxation 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 Sep 2019to Jan 2020
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet Diagnostic and Statistical Manual (DSM-IV) diagnosis of depression
- Consent to participate in the study and to be randomized to one of two groups
Who cannot join
- Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
- History of epilepsy or head trauma
- Eye disorders
- History of electroconvulsive therapy in the past 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001
About this study
The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.
- Conditions
- MDD
- Being tested
- Mindfulness-Based Training, Relaxation Training
- Keywords
- eye-tracking, eye movement, mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based TrainingBehavioural
Mindfulness-Based Training comprises of mindful walking, body scanning and raisin meditation exercise. Participants will receive a guided session of mindfulness meditation, and will be asked to finish at least 30 minutes of Mindfulness-Based Training every day as homework as well as keep a diary describing their experiences and reflections. An expert in mindfulness practice will offer feedback and answer any questions online.
Relaxation TrainingBehavioural
Participants will listen to a 15-minute Relaxation Training tape twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Training | Experimental | Participants in the Mindfulness-Based Training arm will receive 2 weeks of Mindfulness-Based Training for at least 30 minutes every day. Receives: Behavioral: Mindfulness-Based Training |
| Relaxation Training | Active comparator | Participants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day. Receives: Behavioral: Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks
The first fixated location and latency (msec) of each trial, the total dwell time (msec) in each interest area (IA) during the whole trial to assess the attentional bias in the experiment.
Measured: at baseline and in 2 weeks
Secondary outcomes (4)
Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks
Measured by Beck Depression Inventory (BDI-II). BDI-II is a self-report questionnaire that measures the severity of depression on a scale of 0 to 63. Higher total scores indicate more severe depressive symptoms.
Measured: at baseline and in 2 weeks
Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks
Measured by Hamilton Rating Scale for Depression (HAM-D). HAM-D is used by clinicians to rate the severity of depression and to evaluate recovery. HAM-D score ranges from 0 to 51, with higher scores indicating more severe depressive symptoms.
Measured: at baseline and in 2 weeks
Mean Change from Baseline in State Mindfulness at 2 Weeks
Measured by the Five Facet Mindfulness Questionnaire (FFMQ). FFMQ measures five mindfulness skills through these subscales: Non-Reactivity to Inner Experience, Observing/Noticing, Acting With Awareness, Describing, and Non-Judging of Experience. The five subscale scores can be combined to yield a total score ranging from 0 to 195, measuring global mindfulness skills, with higher scores indicating higher level of global mindfulness skills. For FFMQ subscales, scores range from 8 to 40, except for Non-Reactivity to Experience scores, which range from 7 to 35. Higher subscale scores indicate higher level of respective mindfulness skills.
Measured: at baseline and in 2 weeks
Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks
Measured by the Ruminative Responses Scale of the Response Styles Questionnaire (RRS). RRS measures the tendency to ruminate. RRS score ranges from 22 to 88, with higher scores indicate a stronger tendency to engage in ruminative thoughts.
Measured: at baseline and in 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingjiang Li, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071886
- Sponsor's protocol ID
- Second Xiangya hospital EMEN
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
- ClinicalTrials.gov ID
- NCT04071886
- Acronym / sponsor ID
- Second Xiangya hospital EMEN
- Conditions
- MDD
- Keywords
- eye-tracking, eye movement, mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Training | Experimental | Behavioral: Mindfulness-Based TrainingParticipants in the Mindfulness-Based Training arm will receive 2 weeks of Mindfulness-Based Training for at least 30 minutes every day. |
| Relaxation Training | Active comparator | Behavioral: Relaxation TrainingParticipants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet Diagnostic and Statistical Manual (DSM-IV) diagnosis of depression
- Consent to participate in the study and to be randomized to one of two groups
Key exclusion criteria (4 listed)
- Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months
- History of epilepsy or head trauma
- Eye disorders
- History of electroconvulsive therapy in the past 4 weeks.
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-Based TrainingMindfulness-Based Training comprises of mindful walking, body scanning and raisin meditation exercise. Participants will receive a guided session of mindfulness meditation, and will be asked to finish at least 30 minutes of Mindfulness-Based Training every day as homework as well as keep a diary describing their experiences and reflections. An expert in mindfulness practice will offer feedback and answer any questions online. | Behavioural | Mindfulness-Based Training |
| Relaxation TrainingParticipants will listen to a 15-minute Relaxation Training tape twice a day. | Behavioural | Relaxation Training |
Primary outcome
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks
Time frame: at baseline and in 2 weeks
The first fixated location and latency (msec) of each trial, the total dwell time (msec) in each interest area (IA) during the whole trial to assess the attentional bias in the experiment.
4 secondary outcomes
Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks
Time frame: at baseline and in 2 weeks
Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks
Time frame: at baseline and in 2 weeks
Mean Change from Baseline in State Mindfulness at 2 Weeks
Time frame: at baseline and in 2 weeks
Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks
Time frame: at baseline and in 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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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.
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-Based Training and Relaxation Training in people with MDD, run by Central South University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Lingjiang, MD Ph.D (+86 13807314575, LLJ2920@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks (time frame: at baseline and in 2 weeks). 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 28 Aug 2019.