DepressionNCT02457936
Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Therapy for Depressed Individuals
A study testing Mindfulness Based Cognitive Therapy in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Depression one of the leading causes of disability worldwide. Individuals suffering from depression typically exhibit impairments in various mental abilities, such as the ability to effectively direct and control attention and the ability to switch between thinking about different things and concepts (commonly… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reporting dysphoria for at least two months prior
- HAM-D score of at least 11
- No history of psychiatric disorders of psychotic features, neurological disorders, or substance abuse in the past 6 months
- Verified age between 18-65 years old
- Had no suicidal attempts during the past six months
- No prior experience with MBCT or other systematic meditation programs
Who cannot join
- History of psychosis, neurological disorder, and substance abuse for the past 6 months
- Suicide attempt in past 6 months
- Prior experience with MBCT or other systematic meditation program
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02129
About this study
Official title: Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Cognitive Therapy for Depressed Individuals
Depression one of the leading causes of disability worldwide. Individuals suffering from depression typically exhibit impairments in various mental abilities, such as the ability to effectively direct and control attention and the ability to switch between thinking about different things and concepts (commonly referred to as "cognitive flexibility").
Mindfulness meditation training is a technique which involves focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. It has been well documented to improve depressive symptoms and prevent recurrence of depressive episodes, yet little is known about how mindfulness does so and what are the underlying mental mechanisms involved. Here the investigators propose to examine the efficacy of an 8-week mindfulness training program in improving the ability to direct and control attention, as well as in cognitive flexibility.
Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training program. Participants' depressive symptoms as well as their performance on measures of attention and cognitive flexibility will be examined. Participants will be assigned to mindfulness training or a wait-list control group. Half of the participants will be examined before and after the mindfulness training program and the other half will be tested 8-weeks apart and then begin their training.
- Conditions
- Depression
- Being tested
- Mindfulness Based Cognitive Therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
8 weekly meetings in which basic mindfulness and meditation skills are taught, such as breathing meditation, body scan meditation, open awareness meditation, movement meditation, and targeting depression related cognitions and emotions in a mindful manner, as well as awareness exercises, group discussions, and daily home meditation practice routines
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Experimental | This group will receive 8 weeks of Mindfulness Based Cognitive Therapy Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Waiting list | Active comparator | This group will be tested twice 8-10 weeks apart and then receive 8 weeks of Mindfulness Based Cognitive Therapy Receives: Behavioral: Mindfulness Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in depressive symptoms as measured by the Hamilton Depression Rating Scale
Measured: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
Change from baseline in cognitive flexibility, as measured by a computer task involving task-switching and by the Torrance Test for Creative Thinking
Measured: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
Change from baseline in attention regulation, as measured by the Attention Network Test
Measured: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jonathan Greenberg, Massachusetts General Hospital
- Investigators
- Jonathan Greenberg, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457936
- Sponsor's protocol ID
- 2014P002481
- Other IDs
- K23AT010653-01A1
- Status last verified
- Mar 2017
- First submitted
- 20 May 2015
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Cognitive Mechanisms of Clinical Improvement Following Mindfulness Based Cognitive Therapy for Depressed Individuals
- ClinicalTrials.gov ID
- NCT02457936
- Acronym / sponsor ID
- 2014P002481
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
Depression one of the leading causes of disability worldwide. Individuals suffering from depression typically exhibit impairments in various mental abilities, such as the ability to effectively direct and control attention and the ability to switch between thinking about different things and concepts (commonly referred to as "cognitive flexibility").
Mindfulness meditation training is a technique which involves focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations. It has been well documented to improve depressive symptoms and prevent recurrence of depressive episodes, yet little is known about how mindfulness does so and what are the underlying mental mechanisms involved. Here the investigators propose to examine the efficacy of an 8-week mindfulness training program in improving the ability to direct and control attention, as well as in cognitive flexibility.
Individuals diagnosed with recurrent depression will undergo an 8-week mindfulness training program. Participants' depressive symptoms as well as their performance on measures of attention and cognitive flexibility will be examined. Participants will be assigned to mindfulness training or a wait-list control group. Half of the participants will be examined before and after the mindfulness training program and the other half will be tested 8-weeks apart and then begin their training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Cognitive Therapy (MBCT) | Experimental | Behavioral: Mindfulness Based Cognitive TherapyThis group will receive 8 weeks of Mindfulness Based Cognitive Therapy |
| Waiting list | Active comparator | Behavioral: Mindfulness Based Cognitive TherapyThis group will be tested twice 8-10 weeks apart and then receive 8 weeks of Mindfulness Based Cognitive Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Reporting dysphoria for at least two months prior
- HAM-D score of at least 11
- No history of psychiatric disorders of psychotic features, neurological disorders, or substance abuse in the past 6 months
- Verified age between 18-65 years old
- Had no suicidal attempts during the past six months
Key exclusion criteria (3 listed)
- History of psychosis, neurological disorder, and substance abuse for the past 6 months
- Suicide attempt in past 6 months
- Prior experience with MBCT or other systematic meditation program
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 Cognitive Therapy8 weekly meetings in which basic mindfulness and meditation skills are taught, such as breathing meditation, body scan meditation, open awareness meditation, movement meditation, and targeting depression related cognitions and emotions in a mindful manner, as well as awareness exercises, group discussions, and daily home meditation practice routines | Behavioural | Mindfulness Based Cognitive Therapy (MBCT), Waiting list |
Primary outcome
Change from baseline in depressive symptoms as measured by the Hamilton Depression Rating Scale
Time frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
Change from baseline in cognitive flexibility, as measured by a computer task involving task-switching and by the Torrance Test for Creative Thinking
Time frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
Change from baseline in attention regulation, as measured by the Attention Network Test
Time frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program
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 20 Nov 2024.
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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.
Jonathan Greenberg, PhD principal investigator
Massachusetts General Hospital
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 Cognitive Therapy in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
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 6 inclusion and 3 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 20 Nov 2024. 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 United States. 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?
Change from baseline in depressive symptoms as measured by the Hamilton Depression Rating Scale (time frame: Once upon recruitment (baseline), and a second time at 8-10 weeks following the MBCT program). The study lists 3 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 20 Nov 2024.