Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01922219
First received: August 12, 2013
Last updated: October 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cognitive Behavioral Therapy
Depressed 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).
Behavioral: Cognitive Behavioral Therapy
14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922219

Contacts
Contact: Corinne Bart, BA 646-774-7560 bartcor@nyspi.columbia.edu
Contact: Jeffrey Miller, MD 646-774-7613 jm2233@columbia.edu

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Corinne Bart         
Principal Investigator: Jeffrey M Miller, M.D.         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Jeffrey M Miller, M.D. New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01922219     History of Changes
Other Study ID Numbers: #6127, 5K08MH085061
Study First Received: August 12, 2013
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
depression
cognitive therapy
cognitive behavioral therapy
CBT
psychotherapy
MDD
major depressive disorder
MRI
fMRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 22, 2014