Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
NCT ID: NCT00909220
Last Updated: 2018-04-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
77 participants
OBSERVATIONAL
2009-05-31
2012-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neural Correlates of Psychodynamic Psychotherapy for Depression
NCT00812227
Action Tendencies and Prognosis in Major Depressive Disorder
NCT04593537
Prediction of REsponse to Depression Interventions Using Clinical and TD-fNIRS Measurements
NCT06002100
Assessing Change in Short Term Therapy for Depression
NCT02134678
Effects of Treatment on Decision-making in Major Depression
NCT01916824
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Current Major Depressive Disorder
Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) and scores \> 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986) were enrolled into a treatment study at Northwestern University's Feinberg School of Medicine in Chicago, Illinois. This group will receive Behavioral Activation psychotherapy.
Behavioral Activation
Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis \& Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).
Healthy Participants
Another 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were tracked prospectively, naturalistically, for 16 weeks.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Behavioral Activation
Behavioral Activation included up to 16 weekly 50 minute psychotherapy sessions using BA (Addis \& Martell, 2004; Martell et al., 2001, 2010). Techniques included functional analyses to identify the antecedent and consequential aspects of low mood, and interventions such as monitoring daily activities, assessing pleasure/satisfaction and competence achieved via activities, assigning tasks that induce mastery or pleasure, and reducing skill deficits. Clinicians included postdoctoral fellows in clinical psychology (n = 2) or licensed clinical psychologists (n = 2).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Depressed participants should have a current diagnosis of major depressive disorder, as defined by the DSM-IV
Exclusion Criteria
* 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
18 Years
72 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Mental Health (NIMH)
NIH
University of Chicago
OTHER
Dartmouth College
OTHER
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jacqueline Gollan
Associate Professor of Psychiatry and Behavioral Sciences
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jacqueline K. Gollan, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.