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

NCT00909220 | Completed Results DMC

• 1 other identifier: R21MH082133
• Study Type: observational
• Target: 77
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression

Keywords

Major Depressive Disorder, EEG, Negativity bias

Outcome Measures

Primary Outcomes (4)

• 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.

  The Inventory of Depressive Symptomatology-Clinician Rated measure (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 reflects the presence and severity of DSM-IV symptoms of depression. The item scores on this scale are summed to create a total score. Scores range from 0 (minimum score, reflecting no symptoms) to 84 (maximum score, reflecting highest severity). Scores between 0-11 are interpreted as 'no depression'; scores between 12-23 are interpreted as 'mild severity'; scores between 24-36 are interpreted as 'severe'; and total scores between '47-84' are interpreted as 'very severe'.

  Week 16

• 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.

  The Inventory of Depressive Symptomatology, Self-Rated measure (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity completed by the participant. 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'.

  Week 16

• Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment

  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).

  Week 0

• A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).

  The negativity bias, characterized as the tendency to evaluate unpleasant versus pleasant information as more important, was measured using a computer task. Sitting in front of the computer, participants viewed emotionally evocative images and assigned their evaluations of how the intensity of these emotional images using a grid. The grid is comprised of a matrix, with 5 points on the horizontal axis representing the positivity seen in the image (0=not at all, 4 = extremely positive) by 5 points on a vertical axis representing the negativity seen in the image (0=not at all, 4 = extremely negative) matrix. The dimensional variable, negativity bias, is calculated as the difference in the mean ratings of very unpleasant images minutes the positive ratings of the very pleasant images. The Inventory of Depressive Symptomatology, Self-Rated (IDS-SR; Rush et al., 1986, 2003) is a 30-item measure of depression severity provided by the participant.

  Weeks 0-16

Study Arms (2)

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

Healthy Participants

Another 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were tracked prospectively, naturalistically, for 16 weeks.

Interventions

Behavioral Activation BEHAVIORAL

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).

Current Major Depressive Disorder

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Chicago: collaborator
• Dartmouth College: collaborator

Related Publications (3)

• 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.

  PMID: 24674708 RESULT

• 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.

  PMID: 26434794 RESULT

• 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.

  PMID: 26433700 RESULT

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

We enrolled adults who were medication-free, which may limit the generalizability of these results to those individuals who rely on pharmacotherapy and somatic therapies.

Results Point of Contact

• Title: Jackie Gollan, Ph.D. Associate Professor of Psychiatry and Behavioral Sciences
• Organization: Northwestern University

j-gollan@northwestern.edu

312-695-6121

Study Officials

• Jacqueline K. Gollan, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 27, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 17, 2018
• Results First Posted: January 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 01/01/18-01/01/20
• Access Criteria: 01/01/18-01/01/20