Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborators:
University of Chicago
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Jacqueline Gollan, Northwestern University
ClinicalTrials.gov Identifier:
NCT00909220
First received: May 26, 2009
Last updated: April 10, 2013
Last verified: April 2013

May 26, 2009
April 10, 2013
May 2009
April 2012   (final data collection date for primary outcome measure)
Treatment outcome, as measured through the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00909220 on ClinicalTrials.gov Archive Site
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Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
Translating Affective Science to Predict Outcomes of Behavioral Treatment for MDD

This study will determine how people with depression differ from healthy people in brain activity and interpreting emotions, both before and after receiving a psychotherapy treatment.

Major depressive disorder is a serious form of depression that may be treated with psychotherapy. However, up to 40% of adults with depression do not show reduced symptoms when treated with cognitive therapy or behavioral activation (BA), two common forms of psychotherapy. Certain indicators are generally linked with a successful outcome of psychotherapy—demographic and clinical characteristics, comorbidity, and treatment adherence—but no factors reliably predict outcomes of psychotherapy in individuals. This study will test whether two characteristics related to the way people process emotions, affective asymmetry and affective reactivity, can predict whether people with depression will improve with BA therapy.

Both depressed and healthy participants will be recruited for this study. Participation in this study will last 31 weeks. All participants will complete baseline assessments at Weeks 1 and 2. Depressed participants will then begin receiving 16 weekly sessions of BA therapy. All participants will be assessed again after 8, 16, 17, and 28 weeks. Assessments will include the following: a urine toxicology screening; interviews on mental and physical health, family and childhood experiences, and current mood and functioning; computer tasks; recordings of electroencephalography (EEG) activity; recordings of reaction to a startle probe; recordings of electromyography (EMG) activity; recordings of electrodermal activity (EDA); and measurement of blood pressure.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Participants are drawn from the general population through on-line advertisements for the study.

Depression
Behavioral: Behavioral Activation
16 weekly study visits aimed at identifying avoidance patterns used in social or physical situations that contribute to depression and replacing them with reinforcing experiences using directive behavioral strategies
  • 1
    Participants with major depressive disorder
    Intervention: Behavioral: Behavioral Activation
  • 2
    Healthy participants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy participants should have no lifetime history of psychiatric disorder
  • Depressed participants should have a current diagnosis of major depressive disorder, as defined by the DSM-IV

Exclusion Criteria:

  • History of bipolar affective disorder
  • History of psychosis
  • Current non-psychotic Axis I disorder, if it constitutes the predominant aspect of the clinical presentation and immediately requires treatment other than that offered in the study
  • History of substance dependence within the past 6 months
  • Antisocial, borderline, schizotypal, or schizoid personality disorders
  • Evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments
  • Current treatment with catecholaminergic antihypertensive medication, such as reserpine, beta-blockers, clonidine, and alphamethyldopa
  • Current use of antidepressant medication
  • Clear indication of secondary gain
  • Current suicide risk sufficient to preclude treatment on an outpatient basis
  • Severe, unstable concurrent psychiatric conditions likely to require hospitalization within 6 months of study entry
  • Already receiving a targeted psychotherapy aimed at depression
Both
18 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909220
R21 MH082133, R21MH082133
Yes
Jacqueline Gollan, Northwestern University
Northwestern University
  • National Institute of Mental Health (NIMH)
  • University of Chicago
  • Dartmouth-Hitchcock Medical Center
Principal Investigator: Jacqueline K. Gollan, PhD Northwestern University
Northwestern University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP