Mechanisms of Emotion Regulation Underlying Successful CBT in Depression
Combining Electrophysiological, Behavioral and Psychological Measures to Target Mechanisms of Emotion Processing and Regulation During Cognitive Behavior Therapy in Depression
1 other identifier
observational
41
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 31, 2020
CompletedStudy Start
First participant enrolled
November 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2023
CompletedMay 16, 2024
May 1, 2024
2.5 years
March 26, 2020
May 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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)
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)
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
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
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
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
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
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
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)
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)
post-treatment, after about 12 weeks
Secondary Outcomes (2)
REA Fused Words (pre)
pre-treatment, at baseline
REA Fused Words (post)
post-treatment, after about 12 weeks
Study Arms (2)
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)
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.
Interventions
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.
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.
Eligibility Criteria
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)
You may qualify if:
- 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)
You may not qualify if:
- 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;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jürgen Kayser, PhD
NYSPI/RFM/CU
- PRINCIPAL INVESTIGATOR
Ronit Kishon, PhD
NYSPI/RFM/CU
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 12 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist / Professor of Clinical Neurobiology
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 31, 2020
Study Start
November 25, 2020
Primary Completion
June 2, 2023
Study Completion
June 2, 2023
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available 12 months after end of NIMH funding (06/30/2023).
- Access Criteria
- Data will be available through the NIMH Data Archive (NDA depositiory).
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.