Clinical trial NCT01922219: Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression
Official title: Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
cognitive therapy
cognitive behavioral therapy
CBT
psychotherapy
MDD
major depressive disorder
MRI
fMRI
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-08-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Major depressive disorder (MDD) affects 13.1 - 14.2 million American adults annually. Cognitive-behavioral therapy (CBT) is a structured psychotherapy that has been demonstrated in multiple studies to be an effective treatment for MDD. Not all patients achieve a full remission from MDD with CBT, however. Mental health clinicians currently lack clinical or biological markers that can reliably predict treatment outcome with CBT for MDD. Developing such markers could greatly improve clinical outcomes, and could facilitate matching of patients to treatments that are likely to help them. A recent functional magnetic resonance imaging (fMRI) study in healthy individuals examined the neural correlates of cognitive strategies to regulate emotional responses to emotional stimuli. The emotional regulation techniques used in this fMRI study map closely onto the cognitive restructuring techniques that are a primary tool used in CBT for MDD. There is evidence that patients with depression may benefit most from a psychotherapy that draws on their existing strengths. We therefore propose to examine the neural representations of emotion regulation as a predictor of treatment outcome with CBT for MDD. We will recruit subjects with MDD in a current major depressive episode. Research participants will complete baseline psychological and biological assessments, including MRI and functional MRI imaging. Following scanning, subjects will receive 14 sessions of individual CBT for depression over 12 weeks, administered by an experienced psychiatrist or psychologist. Baseline assessments will be examined as predictors of treatment outcome with CBT for depression.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10
timeFrame: 12 weeks
Secondary outcomes:
measure: Post-Treatment Beck Depression Inventory
timeFrame: Post-Treatment, up to 12 weeks
measure: Final Score on the Hamilton Depression Rating Scale
timeFrame: Post-Treatment, up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Jeffrey M Miller, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.