DepressionNCT04265859
Changes in Brain Function Through Repeated Emotion Regulation Training
A study testing Cognitive Behavioral Training and Mindfulness in people with Depression, run by Michael Stevens at 1 site in United States.
Trial summary
This is a pilot study that will investigate how two psychotherapies (re-interpretation and mindfulness) alter brain function. This information will be used to gain understanding of how repeated emotion regulation practices influence the brain and to develop a focused, tactic-based emotional regulation remediation… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavioral Training and Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to Oct 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-50
- Right-handed
- High-school level of education (11th grade attainment for 18 year-olds is acceptable if they haven't completed their final year yet)
- >8th grade English reading level to complete self-report evaluations (most are only available in English).
- For the depressed group, elevated scores on the Beck Depression Inventory - II to validate depressive symptoms.
Who cannot join
- Head injury sufficient to have caused >30 minutes lost consciousness
- Past or current CNS disease (e.g., MS, epilepsy, tumor, etc.)
- Brain lesion identified by MR (structural MR scans will be reviewed by a radiologist for the presence of clinical neuropathology that may affect cognitive task performance)
- Hypertension or juvenile-onset diabetes (current treatment with antihypertensives or insulin)
- Current pregnancy (menstruating females will be tested)
- DSM-IV Axis I lifetime history of Bipolar disorder, PTSD, OCD, psychotic disorder, Tourette's disorder, or any Pervasive Developmental Disorder (e.g., Autistic disorder, PDD NOS, etc.)
Show all 9Show fewer
- For the depressed group, current PTSD
- Current DSM-IV substance dependence, ADHD, Conduct Disorder, MDD
- Any current psychotropic medications
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
Karen L Kesten, MS, 860-545-7776, Karen.kesten@hhchealth.org
Julie Reid, MS, (860) 545-7788, Julie.reid@hhchealth.org
About this study
This is a pilot study that will investigate how two psychotherapies (re-interpretation and mindfulness) alter brain function. This information will be used to gain understanding of how repeated emotion regulation practices influence the brain and to develop a focused, tactic-based emotional regulation remediation approach for treatment of ADHD.
Read the detailed description
The goal of this pilot study is to collect preliminary data that will allow the investigators to formulate theories about ER-related brain function change during intervention-like training that will be tested in larger, externally-funded grant proposals submitted to the National Institutes of Health. The investigators are not especially interested in any existing specific, manualized therapeutic technique. Existing ER-based psychotherapies typically incorporate a variety of related interventions, not all of which focus on the ER component itself. Instead, the investigators will focus on the "building blocks" of such therapies, i.e., the ER interventions themselves and their effect on negative emotional reactions. Here, the investigators ask a specific question - How does ER-elicited brain function change with repeated sessions of guided practice of various ER techniques? In other words, does increasing familiarity or mastery of ER skills through practice change brain function, and how? There are logical hypotheses about the likely nature of brain function changes that can be gleaned from prior neuroimaging research. For instance, if prefrontal cortex activation is important to ER, perhaps practice simply increases such activation. However, pilot work for the current NIMH R01 suggests instead that ER practice might work by enhancing the functional integration among key frontolimbic regions. Complicating such hypotheses is the recognition that different ER tactics engage many distinct brain regions depending on which approach is employed. So a participant's individual brain function differences prior to ER training might be a potent determinant for what sorts of neural changes result from repeated practice. Because all these issues must be evaluated through the lens of a preliminary study before any coherent theoretical model can be formulated, a pilot study is proposed here. Not only will this provide empirical data upon which to base future research, conducting such a pilot will showcase any methodological hurdles or challenges that need to be overcome in order to successfully conduct a larger-scale study.
- Conditions
- Depression
- Being tested
- Cognitive Behavioral Training, Mindfulness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TrainingBehavioural
Also called CBT
The CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways.
MindfulnessBehavioural
The MBT-based regulation training involves using a mindfulness strategy that instructs participants to notice and accept their feelings without judgment or intent to act upon them.
| Study group | Role | What they receive |
|---|---|---|
| Depressed | Experimental | Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10). Receives: Behavioral: Cognitive Behavioral Training; Behavioral: Mindfulness |
| Healthy Control | Other | Participants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10). Receives: Behavioral: Cognitive Behavioral Training; Behavioral: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI Brain Scan
fMRI-assessed brain function data, examined either to detect any changes in activation amplitude ("level of activity") in a priori ER-linked brain regions-of-interest (ROIs) or changes in the degree of functional connectivity among them.
Measured: Visit one and repeated again at Visit two (approximately 4 weeks later)
Secondary outcomes (1)
Beck Depression Inventory - II and State Trait Anxiety Inventory
Depression and anxiety scales (pre and post scores, as evidenced by a decrease in total scores from each scale)
Measured: Enrollment and repeated again at Visit two (approximately 4 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Mar 2021
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
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
- Model description
- Adults having mild-to-moderate levels of depression or who will serve as non-depressed/anxious controls. Participants in each of these study groups then will be randomized into two conditions, each of which will receive 2 assessment/MRI appointments along with 6 sessions of guided practice/training in either 1) Re-interpretation or 2) Mindfulness ER techniques. Immediately after the first and sixth practice sessions, participants also will undergo fMRI so that brain function relative to that stage of practice can be assessed.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Stevens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Stevens, Hartford Hospital
- Investigators
- Michael C Stevens, PhD, Principal investigator, Institute of Living/Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265859
- Sponsor's protocol ID
- R-HCC-2016-0177
- Status last verified
- Aug 2022
- First submitted
- 10 Feb 2020
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Brain Function Through Repeated Emotion Regulation Training
- ClinicalTrials.gov ID
- NCT04265859
- Acronym / sponsor ID
- R-HCC-2016-0177
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Michael StevensUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 12 Feb 2020 (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.
This is a pilot study that will investigate how two psychotherapies (re-interpretation and mindfulness) alter brain function. This information will be used to gain understanding of how repeated emotion regulation practices influence the brain and to develop a focused, tactic-based emotional regulation remediation approach for treatment of ADHD.
Detailed description
The goal of this pilot study is to collect preliminary data that will allow the investigators to formulate theories about ER-related brain function change during intervention-like training that will be tested in larger, externally-funded grant proposals submitted to the National Institutes of Health. The investigators are not especially interested in any existing specific, manualized therapeutic technique. Existing ER-based psychotherapies typically incorporate a variety of related interventions, not all of which focus on the ER component itself. Instead, the investigators will focus on the "building blocks" of such therapies, i.e., the ER interventions themselves and their effect on negative emotional reactions. Here, the investigators ask a specific question - How does ER-elicited brain function change with repeated sessions of guided practice of various ER techniques? In other words, does increasing familiarity or mastery of ER skills through practice change brain function, and how? There are logical hypotheses about the likely nature of brain function changes that can be gleaned from prior neuroimaging research. For instance, if prefrontal cortex activation is important to ER, perhaps practice simply increases such activation. However, pilot work for the current NIMH R01 suggests instead that ER practice might work by enhancing the functional integration among key frontolimbic regions. Complicating such hypotheses is the recognition that different ER tactics engage many distinct brain regions depending on which approach is employed. So a participant's individual brain function differences prior to ER training might be a potent determinant for what sorts of neural changes result from repeated practice. Because all these issues must be evaluated through the lens of a preliminary study before any coherent theoretical model can be formulated, a pilot study is proposed here. Not only will this provide empirical data upon which to base future research, conducting such a pilot will showcase any methodological hurdles or challenges that need to be overcome in order to successfully conduct a larger-scale study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Adults having mild-to-moderate levels of depression or who will serve as non-depressed/anxious controls. Participants in each of these study groups then will be randomized into two conditions, each of which will receive 2 assessment/MRI appointments along with 6 sessions of guided practice/training in either 1) Re-interpretation or 2) Mindfulness ER techniques. Immediately after the first and sixth practice sessions, participants also will undergo fMRI so that brain function relative to that stage of practice can be assessed.
| Arm | Type | Receives |
|---|---|---|
| Depressed | Experimental | Behavioral: Cognitive Behavioral Training, Behavioral: MindfulnessParticipants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10). |
| Healthy Control | Other | Behavioral: Cognitive Behavioral Training, Behavioral: MindfulnessParticipants in this group will be randomized to receive either the CBT training (n=10) or Mindfulness training (n=10). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18-50
- Right-handed
- High-school level of education (11th grade attainment for 18 year-olds is acceptable if they haven't completed their final year yet)
- >8th grade English reading level to complete self-report evaluations (most are only available in English).
- For the depressed group, elevated scores on the Beck Depression Inventory - II to validate depressive symptoms.
Key exclusion criteria (9 listed)
- Head injury sufficient to have caused >30 minutes lost consciousness
- Past or current CNS disease (e.g., MS, epilepsy, tumor, etc.)
- Brain lesion identified by MR (structural MR scans will be reviewed by a radiologist for the presence of clinical neuropathology that may affect cognitive task performance)
- Hypertension or juvenile-onset diabetes (current treatment with antihypertensives or insulin)
- Current pregnancy (menstruating females will be tested)
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 |
|---|---|---|
| Cognitive Behavioral TrainingAlso: CBTThe CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways. | Behavioural | Depressed, Healthy Control |
| MindfulnessThe MBT-based regulation training involves using a mindfulness strategy that instructs participants to notice and accept their feelings without judgment or intent to act upon them. | Behavioural | Depressed, Healthy Control |
Primary outcome
fMRI Brain Scan
Time frame: Visit one and repeated again at Visit two (approximately 4 weeks later)
fMRI-assessed brain function data, examined either to detect any changes in activation amplitude ("level of activity") in a priori ER-linked brain regions-of-interest (ROIs) or changes in the degree of functional connectivity among them.
1 secondary outcome
Beck Depression Inventory - II and State Trait Anxiety Inventory
Time frame: Enrollment and repeated again at Visit two (approximately 4 weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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.
Michael C Stevens, PhD principal investigator
Institute of Living/Hartford 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 Cognitive Behavioral Training and Mindfulness in people with Depression, run by Michael Stevens 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 5 inclusion and 9 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 2 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen L Kesten, MS ((860) 545-7776, Karen.kesten@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI Brain Scan (time frame: Visit one and repeated again at Visit two (approximately 4 weeks later)). 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 2 Aug 2023.