Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression
2 other identifiers
interventional
37
1 country
1
Brief Summary
The purpose of this research study is to learn whether specific types of brain imaging and psychological testing can predict how much benefit patients with depression will receive from a well-studied psychotherapy for depression, called cognitive behavioral therapy (CBT), and how the brain imaging and psychological tests change with treatment. We will also be comparing brain scans from this study between individuals suffering from depression and volunteers without depression. This study offers 14 sessions of one-on-one cognitive-behavioral therapy (CBT) over twelve weeks, administered by an experienced doctoral-level psychologist or psychiatrist.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Dec 2009
Longer than P75 for not_applicable major-depressive-disorder
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
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
March 1, 2017
CompletedSeptember 19, 2017
September 1, 2017
5.7 years
August 12, 2013
December 22, 2016
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10
The primary outcome of this study is remission from depression at the conclusion of 12 weeks of cognitive behavioral therapy for depression. This will be assessed using the Beck Depression Inventory, a self-report questionnaire of symptoms of depression that will be administered at every treatment visit. Remission is defined by a final Beck Depression Inventory score less than or equal to 10.
12 weeks
Secondary Outcomes (2)
Post-Treatment Beck Depression Inventory
Post-Treatment, up to 12 weeks
Final Score on the Hamilton Depression Rating Scale
Post-Treatment, up to 12 weeks
Study Arms (1)
Cognitive Behavioral Therapy
OTHERDepressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).
Interventions
14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks
Eligibility Criteria
You may qualify if:
- In a current major depressive episode
- If currently on medications, lack of benefit after an adequate trial. If currently on medications, willing and able to tolerate a medication washout.
- Ability to provide an informed consent
- For healthy volunteers, no current or past history of depression
You may not qualify if:
- Unstable medical conditions
- Current alcohol or substance abuse or dependence
- Current or past history of other major psychiatric disorders such as Bipolar disorder, schizophrenia, or other psychotic illnesses (Anxiety in depressed participants is okay)
- For females, current pregnancy
- Dementia or neurological disease or head trauma with evidence of cognitive impairment
- Currently taking fluoxetine
- Contraindication to CBT
- Presence of metal in body
- Claustrophobia
- Weight \> 350 pounds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York State Psychiatric Institute
New York, New York, 10032, United States
Related Publications (1)
Pantazatos SP, Yttredahl A, Rubin-Falcone H, Kishon R, Oquendo MA, John Mann J, Miller JM. Depression-related anterior cingulate prefrontal resting state connectivity normalizes following cognitive behavioral therapy. Eur Psychiatry. 2020 Apr 14;63(1):e37. doi: 10.1192/j.eurpsy.2020.34.
PMID: 32284075DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Miller, M.D.
- Organization
- NYSPI
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey M Miller, M.D.
New York State Psychiatric Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 14, 2013
Study Start
December 1, 2009
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
September 19, 2017
Results First Posted
March 1, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share