Predictors of Treatment Outcome With Cognitive Behavioral Therapy for Depression

NCT ID: NCT01922219

Last Updated: 2017-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Interventions

Cognitive Behavioral Therapy

14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey M Miller, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32284075 (View on PubMed)

Other Identifiers

5K08MH085061

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#6127

Identifier Type: -

Identifier Source: org_study_id