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

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ClinicalTrials.gov Identifier: NCT00909220
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : January 15, 2018
Last Update Posted : January 15, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression Behavioral: Behavioral Activation

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.


Study Design

Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Translating Affective Science to Predict Outcomes of Behavioral Treatment for MDD
Study Start Date : May 2009
Primary Completion Date : April 2012
Study Completion Date : April 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
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: 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.


Outcome Measures

Primary Outcome Measures :
  1. Treatment Outcome, as Measured by the Total Score on the Inventory of Depressive Symptomatology, Clinician Rated (IDS-C). [ Time Frame: Weeks 0 and 16 ]
    The Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C; Rush, Giles, Schlesser, Fulton, Weissenburger, Burns, 1986; Rush, Carmody, & Reimitz, 2000; Rush, Trivedi, Ibrahim, Carmody, Arnow, Klein, et al., 2003) is a 30-item measure that assesses DSM-IV symptoms of depression. The item scores on this scale are summed to create a total score (range from 0 (minimum score reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Severity of depression is reflected by total score (e.g., scores between 0-11 is interpreted as 'no depression', scores between 12-23 are interpreted as 'mild severity'; total scores between 24-36 are interpreted as 'severe', and total scores between '47-84' are interpreted as 'very severe'.

  2. Inventory of Depressive Symptomatology - Self-Rated [ Time Frame: Weeks 0 and 16 ]
    The Inventory of Depressive Symptomatology - Self-Rated (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity. The item scores on this scale are summed to create a total score (range from 0 (no symptoms) to 84 (highest severity). The item scores on this scale are summed to create a total score (range from 0 (minimum score reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Severity of depression is reflected by total score (e.g., scores between 0-13 is interpreted as 'no depression', scores between 14-25 are interpreted as 'mild severity'; total scores between 26-48 are interpreted as 'severe', and total scores between '49-84' are interpreted as 'very severe'.

  3. Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment [ Time Frame: Week 0 ]
    Frontal EEG asymmetry scores were calculated over the midfrontal sites, subtracting the natural log of the alpha power of the electrode in the left hemisphere (F3 or F7) from that of the right frontal electrode (F4 or F8), creating one summary alpha asymmetry variable. The absolute value of this difference score was taken. Using the natural log transformation is used in EEG asymmetry research as EEG power appears to be positively skewed. A higher score thus reflected greater relative left versus right frontal activation (e.g., relatively higher right alpha activity).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909220


Sponsors and Collaborators
Northwestern University
National Institute of Mental Health (NIMH)
University of Chicago
Dartmouth College
Investigators
Principal Investigator: Jacqueline K. Gollan, PhD Northwestern University
More Information

Publications:
Responsible Party: Jacqueline Gollan, Associate Professor of Psychiatry and Behavioral Sciences, Northwestern University
ClinicalTrials.gov Identifier: NCT00909220     History of Changes
Other Study ID Numbers: R21MH082133 ( U.S. NIH Grant/Contract )
First Posted: May 27, 2009    Key Record Dates
Results First Posted: January 15, 2018
Last Update Posted: January 15, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Request PI (JGollan) for de-identified data at j-gollan@northwestern.edu
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 01/01/18-01/01/20
Access Criteria: 01/01/18-01/01/20

Keywords provided by Jacqueline Gollan, Northwestern University:
Major Depressive Disorder, EEG, Negativity bias

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