Status:
COMPLETED
Mechanisms of Emotion Regulation Underlying Successful CBT in Depression
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
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), electrop...
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 wil...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
November 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04328103
Start Date
November 25 2020
End Date
June 2 2023
Last Update
May 16 2024
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032