Clinical trial NCT00909220: Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
Official title: Translating Affective Science to Predict Outcomes of Behavioral Treatment for MDD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Major Depressive Disorder, EEG, Negativity bias
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Chicago
name: Dartmouth College
First posted: 2009-05-27
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are drawn from the general population through on-line advertisements for the study.

Brief summary: 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.

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 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

Primary outcomes:
measure: Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Clinician-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.
timeFrame: Week 16
measure: Analyses of Covariance to Test for Group Differences (MDD vs. Healthy) on Patient-rated Depression Severity After 16 Weeks of Behavioral Activation Psychotherapy, Controlling for Baseline Depression Severity.
timeFrame: Week 16
measure: Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment
timeFrame: Week 0
measure: A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).
timeFrame: Weeks 0-16
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Jacqueline K. Gollan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gollan JK, Hoxha D, Chihade D, Pflieger ME, Rosebrock L, Cacioppo J. Frontal alpha EEG asymmetry before and after behavioral activation treatment for depression. Biol Psychol. 2014 May;99:198-208. doi: 10.1016/j.biopsycho.2014.03.003. Epub 2014 Mar 24.
citation: Gollan JK, Hoxha D, Hunnicutt-Ferguson K, Norris CJ, Rosebrock L, Sankin L, Cacioppo J. Twice the negativity bias and half the positivity offset: Evaluative responses to emotional information in depression. J Behav Ther Exp Psychiatry. 2016 Sep;52:166-170. doi: 10.1016/j.jbtep.2015.09.005. Epub 2015 Sep 26.
citation: Gollan JK, Hoxha D, Hunnicutt-Ferguson K, Norris CJ, Rosebrock L, Sankin L, Cacioppo J. The negativity bias predicts response rate to Behavioral Activation for depression. J Behav Ther Exp Psychiatry. 2016 Sep;52:171-178. doi: 10.1016/j.jbtep.2015.09.011. Epub 2015 Sep 28.