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
  Purpose

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.


Condition Intervention
Depression
Behavioral: Behavioral Activation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Translating Affective Science to Predict Outcomes of Behavioral Treatment for MDD

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Treatment outcome, as measured through the Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: May 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Participants with major depressive disorder
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
2
Healthy participants

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  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: NCT00909220

Locations
United States, Illinois
Northwestern University Stress and Depression Laboratory
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
University of Chicago
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Jacqueline K. Gollan, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Jacqueline Gollan, Associate Professor of Psychiatry and Behavioral Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT00909220     History of Changes
Other Study ID Numbers: R21 MH082133, R21MH082133
Study First Received: May 26, 2009
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
Major Depressive Disorder

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

ClinicalTrials.gov processed this record on July 26, 2014