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Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01922219
First received: August 12, 2013
Last updated: September 18, 2017
Last verified: September 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10 [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures:
  • Post-Treatment Beck Depression Inventory [ Time Frame: Post-Treatment, up to 12 weeks ]

    The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression.

    The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex.

    We report the total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale's manual:

    0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression


  • Final Score on the Hamilton Depression Rating Scale [ Time Frame: Post-Treatment, up to 12 weeks ]

    Final score on the Hamilton Depression Rating Scale (HDRS) was calculated for 37 patients who were treated with Cognitive Behavioral Therapy.

    The 17-item HDRS is a clinician-administered scale that quantifies depression severity, and includes items assessing mood, suicidal thinking, insomnia, feelings of guilt, work and activities, somatic symptoms, and insight. It is a well-characterized scale with excellent psychometric properties. The total score is the sum of the individual scores of the 17 scale items. Higher scores indicate greater depression severity. When using this outcome measure, we covary for baseline HDRS scores. Published norms for interpretation of the 17-item HDRS use a different version of the scale with a total possible score of 52, and are listed below. Interpretation is comparable (but not identical) with the 17-item HDRS version used in this study, which has a maximum score is 51.

    None: 0-7 Mild: 8-13 Moderate: 14-19 Severe: 20-25 Very Severe: 26-52



Enrollment: 37
Study Start Date: December 2009
Study Completion Date: August 2015
Primary Completion Date: August 2015 (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   (Adult)
Sexes Eligible for Study:   All
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

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jeffrey M Miller, M.D. New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01922219     History of Changes
Other Study ID Numbers: #6127
5K08MH085061 ( U.S. NIH Grant/Contract )
Study First Received: August 12, 2013
Results First Received: December 22, 2016
Last Updated: September 18, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 20, 2017