Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:9/20/2017
Start Date:December 2009
End Date:August 2015

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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.

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.

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
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
646-774-5000
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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from
New York, NY
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