DepressionNCT02816502
Hippocampal Plasticity of Young Adults With Childhood Adversity
A study testing Stress Management Skill Building Program A and Stress Management Skill Building Program B in people with Depression and Anxiety, run by Mclean Hospital at 1 site in United States.
Trial summary
This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which… Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Stress Management Skill Building Program A and Stress Management Skill Building Program B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 7 Jul 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- having childhood adversity
- no history of psychiatric disorders of psychotic features or neurological disorders
- verified age between 21-35 years old;
- no suicidal attempts during the past six months;
- being determined by the clinician to have the capability to comply with the program requirements and not detrimental to other participants in the group;
- passing MRI eligibility criteria.
- provided written informed consent to participate in this study;
- committed to meeting the requirement of refraining from using marijuana or illicit drugs.
Who cannot join
- psychosis
- active suicidal attempts during the past 6 months
- psychoactive substance abuse
- MRI exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.
- Conditions
- Depression, Anxiety
- Being tested
- Stress Management Skill Building Program A, Stress Management Skill Building Program B
- Keywords
- childhood, adversity
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management Skill Building Program ABehavioural
Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.
Stress Management Skill Building Program BBehavioural
Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.
| Study group | Role | What they receive |
|---|---|---|
| Stress Management Skill Building Program A | Experimental | An eight week skill building group in which subjects meet with the teacher and other students in the group once a week, and complete homework and practice log during the week. Receives: Behavioral: Stress Management Skill Building Program A |
| Stress Management Skill Building Program B | Active comparator | An eight week skill building group in which subjects meet with the teacher and other students in the group once a week, and complete homework and practice log during the week. Receives: Behavioral: Stress Management Skill Building Program B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T
Measured: before and after the 8-week intervention
Secondary outcomes (3)
Changes in stress level measured by the Perceived Stress Scale (PSS)
Measured: before and after the 8-week intervention
Changes in severity of depression symptom measured by Beck Depression Inventory (BDI)
Measured: before and after the 8-week intervention
Changes in severity of anxiety symptom measured by State-Trait Anxiety Inventory (STAI)
Measured: before and after the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start15 Jun 2017
- Primary completion1 Dec 2018
- Study completion7 Jul 2020
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.
- 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
- Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Diane Yan, Mclean Hospital
- Investigators
- Diane Joss, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816502
- Sponsor's protocol ID
- 2016P000335
- Status last verified
- Mar 2021
- First submitted
- 16 Jun 2016
- Last updated
- 25 Mar 2021
- 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 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampal Plasticity of Young Adults With Childhood Adversity
- ClinicalTrials.gov ID
- NCT02816502
- Acronym / sponsor ID
- 2016P000335
- Conditions
- Depression, Anxiety
- Keywords
- childhood, adversity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 28 Jun 2016 (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.
This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Management Skill Building Program A | Experimental | Behavioral: Stress Management Skill Building Program AAn eight week skill building group in which subjects meet with the teacher and other students in the group once a week, and complete homework and practice log during the week. |
| Stress Management Skill Building Program B | Active comparator | Behavioral: Stress Management Skill Building Program BAn eight week skill building group in which subjects meet with the teacher and other students in the group once a week, and complete homework and practice log during the week. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- having childhood adversity
- no history of psychiatric disorders of psychotic features or neurological disorders
- verified age between 21-35 years old;
- no suicidal attempts during the past six months;
- being determined by the clinician to have the capability to comply with the program requirements and not detrimental to other participants in the group;
Key exclusion criteria (4 listed)
- psychosis
- active suicidal attempts during the past 6 months
- psychoactive substance abuse
- MRI exclusion criteria
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 |
|---|---|---|
| Stress Management Skill Building Program ASubject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week. | Behavioural | Stress Management Skill Building Program A |
| Stress Management Skill Building Program BSubject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week. | Behavioural | Stress Management Skill Building Program B |
Primary outcome
Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T
Time frame: before and after the 8-week intervention
3 secondary outcomes
Changes in stress level measured by the Perceived Stress Scale (PSS)
Time frame: before and after the 8-week intervention
Changes in severity of depression symptom measured by Beck Depression Inventory (BDI)
Time frame: before and after the 8-week intervention
Changes in severity of anxiety symptom measured by State-Trait Anxiety Inventory (STAI)
Time frame: before and after the 8-week intervention
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 25 Mar 2021.
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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.
Diane Joss, PhD principal investigator
Mclean 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 Stress Management Skill Building Program A and Stress Management Skill Building Program B in people with Depression and Anxiety, run by Mclean 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 8 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: finished, as of the sponsor's last update on 25 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?
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?
Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T (time frame: before and after the 8-week intervention). 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 25 Mar 2021.