Major Depressive DisorderNCT04328103
Mechanisms of Emotion Regulation Underlying Successful CBT in Depression
An observational study of Major Depressive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This research aims to elucidate mechanisms through which change occurs during cognitive behavior therapy (CBT) for depression. Assessing meta-cognitive processes of self-knowledge (top-down), electrophysiological and behavioral correlates of emotion processing (bottom-up), and their relation to treatment outcome will… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cognitive Behavior Therapy (CBT) and Nonspecific Supportive Therapy (PBO)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 2 Jun 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- 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
Study population: Right-handed MDD patients (N = 60; Beck Depression Inventory [BDI] > 12, Hamilton Rating Scale for Depression [HRSD] > 13), aged 18 to 65 (~half male), recruited through the Depression Evaluation Service at NY State Psychiatric Institute (NYSPI)
Who may be able to join
- aged 18-65
- right-handed
- be able to speak English well enough to comprehend and comply with protocol requirements
- recruited to achieve equal gender representation (i.e. about half male) in both treatment arms
- medically healthy individuals will be included as MDD patients if they:
- meet DSM-5 criteria for a current MDD episode based on a structured clinical interview (SCID);
- score greater or equal to 13 on the Beck Depression Inventory (BDI-II)
- score greater or equal to 14 on the Hamilton Rating Scale for Depression (HRSD)
Who cannot join
- Participants are excluded for any of the following reasons or DSM-5 criteria:
- substance abuse or dependence (including alcohol) in last 6 months;
- positive toxicology screen as determined by blood/urine testing (e.g. thyroid dysfunction, street drug use);
- history of schizophrenia or other current psychotic disorder;
- MDD with psychotic or catatonic features;
- Bipolar I, II Affective Disorder;
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- Organic Mental Disease;
- significant suicidal ideation with a plan and intent, also assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS), that cannot be managed safely as an outpatient, or homicidal ideation (suicidality monitored throughout study);
- a primary diagnosis of panic disorder, obsessive-compulsive disorder, psychogenic pain disorder, anorexia/bulimia, or any unstable medical condition;
- any recent (less than or equal to 12 mos) history of CBT (as determined during an in-person interview);
- prior seizure disorder, significant head trauma or other neurological disorders;
- lack of capacity to give informed consent;
- received psychotropic medication, over-the-counter antidepressant, or any non-CBT intervention (e.g. deep breathing, meditation/mindfulness, psychotherapy - except for minimal supportive nonspecific therapy PBO) for at least 1 month prior to recruitment (3 months for fluexetine);
- hearing loss (>30 dB in either ear) or hearing asymmetry (>10 dB across ears) assessed via standard audiogram
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Combining Electrophysiological, Behavioral and Psychological Measures to Target Mechanisms of Emotion Processing and Regulation During Cognitive Behavior Therapy in Depression
This research aims to elucidate mechanisms through which change occurs during cognitive behavior therapy (CBT) for depression. Assessing meta-cognitive processes of self-knowledge (top-down), electrophysiological and behavioral correlates of emotion processing (bottom-up), and their relation to treatment outcome will provide new insights into the mechanisms of emotion regulation deficits in depression. It will also contribute toward the clinical goal of identifying patients who may benefit most from CBT for unipolar depression.
Read the detailed description
This R21 application aims to clarify the neurobiological mechanisms by which change occurs during cognitive behavior therapy (CBT) for major depressive disorder (MDD). This hypothesis-driven study will explore the association between the psychological constructs of psychological mindedness (PM) and mindfulness (M) during the time course of CBT for MDD, and its relationship to electrophysiological and behavioral measures of automatic (i.e. stimulus-driven or bottom-up) emotion processing. This objective is motivated by the following rationale: PM and M represent different meta-cognitive processes of self-knowledge deemed critical for emotion regulation (ER) and CBT success. Event-related potentials (ERPs) to salient affective pictures reflect different stages of motivated attention. Using advanced analytic EEG techniques, we have linked these stages to the hierarchical activation of 'emotional' brain regions along the occipitotemporal ventral stream, ranging from preconscious stimulus categorization (right secondary visual cortex, right temporoparietal junction) to conscious appraisal (posterior cingulate cortex, ventromedial cortex). Importantly, blunted ERP responses to emotionally-arousing stimuli have been observed in clinical depression, and hypoactivation of right temporoparietal and dorsolateral prefrontal regions normalize after successful antidepressant or electroconvulsive treatment. A dichotic emotion recognition test, which provides an auditory measure of bottom-up emotion processing in form of a left ear (right hemisphere) advantage for recognizing the emotional intonation of speech patterns, has revealed behavioral deficits in MDD patients. Moreover, an increased right ear advantage for verbal stimuli (left hemisphere) is seen in CBT responders. Employing a sample of 60 MDD patients randomly assigned to CBT or nonspecific supportive therapy (placebo), we will obtain psychological, electrophysiological, behavioral and clinical outcome measures of response to 12 weeks of CBT in a pre-post treatment design to determine: (1) when and where in the brain automatic emotion processing is altered by CBT; (2) if changes in emotional responding are moderated or mediated by meta-cognitive processes of self-knowledge; and, (3) if these measures, alone or in combination, have promise as markers of CBT treatment response. Existing ERP and behavioral data for healthy adults (HC) obtained using the same experimental protocols will provide normative (yardstick) data. This study brings together experienced clinical psychologists and psychiatrists doing treatment and research in depression with investigators having expertise in affective neuroscience and electrophysiological studies in MDD. It will provide a critical new step for outlining the affective-cognitive and neurophysiological mechanisms of ER by which change through CBT occurs. Apart from their theoretical relevance, the findings of this project will also aid in developing novel and more targeted interventions and in identifying patients who may benefit most from CBT for unipolar depression.
- Conditions
- Major Depressive Disorder
- Being tested
- Cognitive Behavior Therapy (CBT), Nonspecific Supportive Therapy (PBO)
- Keywords
- Cognitive Behavioral Therapy (CBT), Motivated Attention, Psychological Mindedness, Mindfulness, Visual Half-Field paradigm, Dichotic Listenting, Emotion Recognition Task, Left Ear Advantage (LEA), Emotion Regulation, Event-Related Potential (ERP), Meta-Cognitive Processes
- Medical subject headings
- Depressive Disorder, Major, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy (CBT)Behavioural
Following established procedures at the DES at NYSPI, 12 sessions of individual manual-driven CBT (Emery, 2000) will be conducted by highly trained master degree clinicians.
Nonspecific Supportive Therapy (PBO)Behavioural
As a non-CBT intervention that includes warmth, genuineness and empathy (Linde et al., 2011), nonspecific supportive therapy (PBO) will be administered in a parallel format to CBT, also consisting of 12 individual sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavior Therapy (CBT) | Following established procedures at the Depression Evaluation Service (DES) at New York State Psychiatri Institute (NYSPI), 12 sessions of individual manual-driven CBT (Emery, 2000) will be conducted by highly trained master degree clinicians. Receives: Behavioral: Cognitive Behavior Therapy (CBT) | |
| Nonspecific Supportive Therapy (PBO) | As a non-CBT intervention that includes warmth, genuineness and empathy (Linde et al., 2011), nonspecific supportive therapy (PBO) will be administered in a parallel format to CBT, also consisting of 12 individual sessions. Receives: Behavioral: Nonspecific Supportive Therapy (PBO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRSD slope
17-item Hamilton Rating Scale for Depression (HRSD); standard clinical instrument (Hamilton, 1960) to assess symptom severity in major depressive disorder (MDD); interpretation: < 7 = absence or remission of depression; 7-17 = mild depression; 18-24 = moderate depression; > 25 = severe depression;
HRSD rate of symptom change over time (slope); to obtain a continuous measure of treatment outcome, we will employ a mixed-effects model for all HRSD ratings to compute estimates of each patient's rate of symptom change over time (slope of HRSD scores; Petkova et al 2017)
Measured: 12 weeks or up to 12 weeks
BDI slope
Beck Depression Inventory (BDI-II); standard clinical instrument (Beck 1966) to assess symptom severity in depression; interpretation: < 14 = minimal range; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression;
BDI-II rate of symptom change over time (slope); To obtain a continuous measure of treatment outcome, we will employ a mixed-effects model for all BDI ratings to compute estimates of each patient's rate of symptom change over time (slope of BDI scores; Petkova et al 2017)
Measured: 12 weeks or up to 12 weeks
N2 sink (pre)
N2 sink (ERP, Emotional Hemifield Task); early (212 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting asymmetrical neuronal sources involving striate and prestriate cortex in the occipital lobe, with a maximum activation in the right middle temporal gyrus
Measured: pre-treatment, at baseline
N2 sink (post)
N2 sink (ERP, Emotional Hemifield Task); early (212 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting asymmetrical neuronal sources involving striate and prestriate cortex in the occipital lobe, with a maximum activation in the right middle temporal gyrus
Measured: post-treatment, after about 12 weeks
P3 source (pre)
P3 source (ERP, Emotional Hemifield Task); mid-latency (385 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting neuronal sources involving medial parietal lobe, with a maximum activation in the posterior cingulate cortex
Measured: pre-treatment, at baseline
P3 source (post)
P3 source (ERP, Emotional Hemifield Task); mid-latency (385 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting neuronal sources involving medial parietal lobe, with a maximum activation in the posterior cingulate cortex
Measured: post-treatment, after about 12 weeks
CP source (pre)
CP source (ERP, Emotional Hemifield Task); late (630 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting bilateral generator sources within the temporal lobe, with a maximum activations in uncus and the inferior temporal area
Measured: pre-treatment, at baseline
CP source (post)
CP source (ERP, Emotional Hemifield Task); late (630 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting bilateral generator sources within the temporal lobe, with a maximum activations in uncus and the inferior temporal area
Measured: post-treatment, after about 12 weeks
LEA ERT (pre)
LEA ERT (dichotic listing behavior, Emotional Recognition Task); measures extent of right hemisphere dominance or left ear advantage (LEA) for recognizing prosody during a dichotic emotional recognition task (Bruder et al 2016)
Measured: pre-treatment, at baseline
LEA ERT (post)
LEA ERT (dichotic listing behavior, Emotional Recognition Task); measures extent of right hemisphere dominance or left ear advantage (LEA) for recognizing prosody during a dichotic emotional recognition task (Bruder et al 2016)
Measured: post-treatment, after about 12 weeks
Secondary outcomes (2)
REA Fused Words (pre)
REA Fused Words (dichotic listing behavior); measures extent of left hemisphere dominance or right ear advantage (REA) for verbal processing (Bruder et al 1997, 2017)
Measured: pre-treatment, at baseline
REA Fused Words (post)
REA Fused Words (dichotic listing behavior); measures extent of left hemisphere dominance or right ear advantage (REA) for verbal processing (Bruder et al 1997, 2017)
Measured: post-treatment, after about 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start25 Nov 2020
- Primary completion2 Jun 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jürgen Kayser, PhD, New York State Psychiatric Institute
- Investigators
- Jürgen Kayser, PhD, Principal investigator, NYSPI/RFM/CURonit Kishon, PhD, Principal investigator, NYSPI/RFM/CU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328103
- Sponsor's protocol ID
- 6559R
- Status last verified
- May 2024
- First submitted
- 26 Mar 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The institution and PIs will adhere to the NIH Data Sharing Policy (Notice of Data Sharing Policy for the National Institute of Mental Health NOT-MH-19-033). Accordingly, we will deposit de-identified individual raw and analyzed data (primary and secondary outcome measures) from experiments involving human subjects into the NIMH Data Archive (NDA) infrastructure (i.e., for all data for which we will obtain informed consent). Raw data will be submitted to NDA every 6 months and include demographic, self-report, clinical, and EEG, following NDA Harmonization Standards (i.e., for clinical/phenotypic data and neuro-signal recordings) and using NDA GUIDs. These submissions will undergo validations and other quality control checks as the data are deposited.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Electrophysiological, Behavioral and Psychological Measures to Target Mechanisms of Emotion Processing and Regulation During Cognitive Behavior Therapy in Depression
- ClinicalTrials.gov ID
- NCT04328103
- Acronym / sponsor ID
- 6559R
- Conditions
- Major Depressive Disorder
- Keywords
- Cognitive Behavioral Therapy (CBT), Motivated Attention, Psychological Mindedness, Mindfulness, Visual Half-Field paradigm, Dichotic Listenting, Emotion Recognition Task, Left Ear Advantage (LEA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 31 Mar 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 research aims to elucidate mechanisms through which change occurs during cognitive behavior therapy (CBT) for depression. Assessing meta-cognitive processes of self-knowledge (top-down), electrophysiological and behavioral correlates of emotion processing (bottom-up), and their relation to treatment outcome will provide new insights into the mechanisms of emotion regulation deficits in depression. It will also contribute toward the clinical goal of identifying patients who may benefit most from CBT for unipolar depression.
Detailed description
This R21 application aims to clarify the neurobiological mechanisms by which change occurs during cognitive behavior therapy (CBT) for major depressive disorder (MDD). This hypothesis-driven study will explore the association between the psychological constructs of psychological mindedness (PM) and mindfulness (M) during the time course of CBT for MDD, and its relationship to electrophysiological and behavioral measures of automatic (i.e. stimulus-driven or bottom-up) emotion processing. This objective is motivated by the following rationale: PM and M represent different meta-cognitive processes of self-knowledge deemed critical for emotion regulation (ER) and CBT success. Event-related potentials (ERPs) to salient affective pictures reflect different stages of motivated attention. Using advanced analytic EEG techniques, we have linked these stages to the hierarchical activation of 'emotional' brain regions along the occipitotemporal ventral stream, ranging from preconscious stimulus categorization (right secondary visual cortex, right temporoparietal junction) to conscious appraisal (posterior cingulate cortex, ventromedial cortex). Importantly, blunted ERP responses to emotionally-arousing stimuli have been observed in clinical depression, and hypoactivation of right temporoparietal and dorsolateral prefrontal regions normalize after successful antidepressant or electroconvulsive treatment. A dichotic emotion recognition test, which provides an auditory measure of bottom-up emotion processing in form of a left ear (right hemisphere) advantage for recognizing the emotional intonation of speech patterns, has revealed behavioral deficits in MDD patients. Moreover, an increased right ear advantage for verbal stimuli (left hemisphere) is seen in CBT responders. Employing a sample of 60 MDD patients randomly assigned to CBT or nonspecific supportive therapy (placebo), we will obtain psychological, electrophysiological, behavioral and clinical outcome measures of response to 12 weeks of CBT in a pre-post treatment design to determine: (1) when and where in the brain automatic emotion processing is altered by CBT; (2) if changes in emotional responding are moderated or mediated by meta-cognitive processes of self-knowledge; and, (3) if these measures, alone or in combination, have promise as markers of CBT treatment response. Existing ERP and behavioral data for healthy adults (HC) obtained using the same experimental protocols will provide normative (yardstick) data. This study brings together experienced clinical psychologists and psychiatrists doing treatment and research in depression with investigators having expertise in affective neuroscience and electrophysiological studies in MDD. It will provide a critical new step for outlining the affective-cognitive and neurophysiological mechanisms of ER by which change through CBT occurs. Apart from their theoretical relevance, the findings of this project will also aid in developing novel and more targeted interventions and in identifying patients who may benefit most from CBT for unipolar depression.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy (CBT) | – | Behavioral: Cognitive Behavior Therapy (CBT)Following established procedures at the Depression Evaluation Service (DES) at New York State Psychiatri Institute (NYSPI), 12 sessions of individual manual-driven CBT (Emery, 2000) will be conducted by highly trained master degree clinicians. |
| Nonspecific Supportive Therapy (PBO) | – | Behavioral: Nonspecific Supportive Therapy (PBO)As a non-CBT intervention that includes warmth, genuineness and empathy (Linde et al., 2011), nonspecific supportive therapy (PBO) will be administered in a parallel format to CBT, also consisting of 12 individual sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Right-handed MDD patients (N = 60; Beck Depression Inventory [BDI] > 12, Hamilton Rating Scale for Depression [HRSD] > 13), aged 18 to 65 (~half male), recruited through the Depression Evaluation Service at NY State Psychiatric Institute (NYSPI)
Key inclusion criteria (8 listed)
- aged 18-65
- right-handed
- be able to speak English well enough to comprehend and comply with protocol requirements
- recruited to achieve equal gender representation (i.e. about half male) in both treatment arms
- medically healthy individuals will be included as MDD patients if they:
Key exclusion criteria (14 listed)
- Participants are excluded for any of the following reasons or DSM-5 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 |
|---|---|---|
| Cognitive Behavior Therapy (CBT)Following established procedures at the DES at NYSPI, 12 sessions of individual manual-driven CBT (Emery, 2000) will be conducted by highly trained master degree clinicians. | Behavioural | Cognitive Behavior Therapy (CBT) |
| Nonspecific Supportive Therapy (PBO)As a non-CBT intervention that includes warmth, genuineness and empathy (Linde et al., 2011), nonspecific supportive therapy (PBO) will be administered in a parallel format to CBT, also consisting of 12 individual sessions. | Behavioural | Nonspecific Supportive Therapy (PBO) |
Primary outcome
HRSD slope
Time frame: 12 weeks or up to 12 weeks
17-item Hamilton Rating Scale for Depression (HRSD); standard clinical instrument (Hamilton, 1960) to assess symptom severity in major depressive disorder (MDD); interpretation: < 7 = absence or remission of depression; 7-17 = mild depression; 18-24 = moderate depression; > 25 = severe depression; HRSD rate of symptom change over time (slope); to obtain a continuous measure of treatment outcome, we will employ a mixed-effects model for all HRSD ratings to compute estimates of each patient's rate of symptom change over time (slope of HRSD scores; Petkova et al 2017)
BDI slope
Time frame: 12 weeks or up to 12 weeks
Beck Depression Inventory (BDI-II); standard clinical instrument (Beck 1966) to assess symptom severity in depression; interpretation: < 14 = minimal range; 14-19 = mild depression; 20-28 = moderate depression; 29-63 = severe depression; BDI-II rate of symptom change over time (slope); To obtain a continuous measure of treatment outcome, we will employ a mixed-effects model for all BDI ratings to compute estimates of each patient's rate of symptom change over time (slope of BDI scores; Petkova et al 2017)
N2 sink (pre)
Time frame: pre-treatment, at baseline
N2 sink (ERP, Emotional Hemifield Task); early (212 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting asymmetrical neuronal sources involving striate and prestriate cortex in the occipital lobe, with a maximum activation in the right middle temporal gyrus
N2 sink (post)
Time frame: post-treatment, after about 12 weeks
N2 sink (ERP, Emotional Hemifield Task); early (212 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting asymmetrical neuronal sources involving striate and prestriate cortex in the occipital lobe, with a maximum activation in the right middle temporal gyrus
P3 source (pre)
Time frame: pre-treatment, at baseline
P3 source (ERP, Emotional Hemifield Task); mid-latency (385 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting neuronal sources involving medial parietal lobe, with a maximum activation in the posterior cingulate cortex
P3 source (post)
Time frame: post-treatment, after about 12 weeks
P3 source (ERP, Emotional Hemifield Task); mid-latency (385 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting neuronal sources involving medial parietal lobe, with a maximum activation in the posterior cingulate cortex
CP source (pre)
Time frame: pre-treatment, at baseline
CP source (ERP, Emotional Hemifield Task); late (630 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting bilateral generator sources within the temporal lobe, with a maximum activations in uncus and the inferior temporal area
CP source (post)
Time frame: post-treatment, after about 12 weeks
CP source (ERP, Emotional Hemifield Task); late (630 ms peak latency) emotional ERP LPP subcomponent derived from combined CSD-tPCA approach (Kayser et al 2016, 2017) reflecting bilateral generator sources within the temporal lobe, with a maximum activations in uncus and the inferior temporal area
LEA ERT (pre)
Time frame: pre-treatment, at baseline
LEA ERT (dichotic listing behavior, Emotional Recognition Task); measures extent of right hemisphere dominance or left ear advantage (LEA) for recognizing prosody during a dichotic emotional recognition task (Bruder et al 2016)
LEA ERT (post)
Time frame: post-treatment, after about 12 weeks
LEA ERT (dichotic listing behavior, Emotional Recognition Task); measures extent of right hemisphere dominance or left ear advantage (LEA) for recognizing prosody during a dichotic emotional recognition task (Bruder et al 2016)
2 secondary outcomes
REA Fused Words (pre)
Time frame: pre-treatment, at baseline
REA Fused Words (post)
Time frame: post-treatment, after about 12 weeks
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 16 May 2024.
- Individual participant dataSharing planned: Yes. The institution and PIs will adhere to the NIH Data Sharing Policy (Notice of Data Sharing Policy for the National Institute of Mental Health NOT-MH-19-033). Accordingly, we will deposit de-identified individual raw and analyzed data (primary and secondary outcome measures) from experiments involving human subjects into the NIMH Data Archive (NDA) infrastructure (i.e., for all data for which we will obtain informed consent). Raw data will be submitted to NDA every 6 months and include demographic, self-report, clinical, and EEG, following NDA Harmonization Standards (i.e., for clinical/phenotypic data and neuro-signal recordings) and using NDA GUIDs. These submissions will undergo validations and other quality control checks as the data are deposited.
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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.
Jürgen Kayser, PhD principal investigator
NYSPI/RFM/CU
Ronit Kishon, PhD principal investigator
NYSPI/RFM/CU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by New York State Psychiatric Institute 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 14 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 16 May 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?
HRSD slope (time frame: 12 weeks or up to 12 weeks). The study lists 10 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 16 May 2024.