DepressionNCT02447744
Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
A study testing Mindfulness based intervention in people with Depression and Anxiety, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, PTSD
- What is being tested?
- Mindfulness based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2014to 21 Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experience of childhood maltreatment
- With current age between 19 to 35 years old
- With current symptoms of depression or anxiety or PTSD or significant general stress.
Who cannot join
- History of psychiatric disorders with psychotic features
- Suicidal attempts during the past six months
- Neurological disorders
- And common MRI exclusion criteria
- Prior history with the mindfulness based stress reduction program or other systematic meditation programs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.
Read the detailed description
This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.
- Conditions
- Depression, Anxiety, PTSD, Trauma, Psychological
- Being tested
- Mindfulness based intervention
- Keywords
- depression, anxiety, childhood trauma, mindfulness
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based interventionBehavioural
The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness group | Experimental | This arm receives an 8-week mindfulness based behavioral intervention program. Receives: Behavioral: Mindfulness based intervention |
| Waitlist control group | Other | This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Receives: Behavioral: Mindfulness based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Subjects' Perceived Stress Level
Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject.
The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed.
Measured: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
Secondary outcomes (1)
Changes of Mindfulness
Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores).
Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject.
The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful.
Measured: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start1 Aug 2014
- Primary completion21 Jul 2016
- Study completion21 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mclean Hospital
- Responsible party
- Principal investigator, Sara W Lazar, Massachusetts General Hospital
- Investigators
- Sara Lazar, PhD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447744
- Sponsor's protocol ID
- 2014P000295
- Status last verified
- Mar 2021
- First submitted
- 2 Dec 2014
- Last updated
- 23 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Joss D, Khan A, Lazar SW, Teicher MH. Effects of a Mindfulness-Based Intervention on Self-Compassion and Psychological Health Among Young Adults With a History of Childhood Maltreatment. Front Psychol. 2019 Oct 23;10:2373. doi: 10.3389/fpsyg.2019.02373. eCollection 2019.
PubMed 31749731
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
- ClinicalTrials.gov ID
- NCT02447744
- Acronym / sponsor ID
- 2014P000295
- Conditions
- Depression, Anxiety, PTSD, Trauma, Psychological
- Keywords
- depression, anxiety, childhood trauma, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Mclean Hospital
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 21 Jul 2016 (actual)
- Study completion
- 21 Jul 2016 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 23 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.
Detailed description
This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness group | Experimental | Behavioral: Mindfulness based interventionThis arm receives an 8-week mindfulness based behavioral intervention program. |
| Waitlist control group | Other | Behavioral: Mindfulness based interventionThis arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Experience of childhood maltreatment
- With current age between 19 to 35 years old
- With current symptoms of depression or anxiety or PTSD or significant general stress.
Key exclusion criteria (5 listed)
- History of psychiatric disorders with psychotic features
- Suicidal attempts during the past six months
- Neurological disorders
- And common MRI exclusion criteria
- Prior history with the mindfulness based stress reduction program or other systematic meditation programs.
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 interventionThe intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. | Behavioural | Mindfulness group, Waitlist control group |
Primary outcome
Changes in Subjects' Perceived Stress Level
Time frame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed.
1 secondary outcome
Changes of Mindfulness
Time frame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31749731Joss D, Khan A, Lazar SW, Teicher MH. Effects of a Mindfulness-Based Intervention on Self-Compassion and Psychological Health Among Young Adults With a History of Childhood Maltreatment. Front Psychol. 2019 Oct 23;10:2373. doi: 10.3389/fpsyg.2019.02373. eCollection 2019.
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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.
Sara Lazar, PhD principal investigator
MGH
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 intervention in people with Depression and Anxiety, 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 3 inclusion and 5 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 23 Mar 2021. 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?
Yes. Results are posted in the registry (first posted 23 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Subjects' Perceived Stress Level (time frame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447744, which also lists 1 linked publication.
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 23 Mar 2021.