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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 16, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Chicago
Dartmouth College
Information provided by (Responsible Party):
Jacqueline Gollan, Northwestern University

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Prospective
Condition Depression
Intervention Behavioral: Behavioral Activation
Enrollment 77
Recruitment Details Participants from each group were recruited from the same community locations via advertisements and the internet. Enrollment began 5/2009 and ended 7/2011.
Pre-assignment Details All depressed participants were enrolled into the Behavioral Activation Treatment arm. All healthy participants were tracked for the duration of the study.
Arm/Group Title Current Major Depressive Disorder Healthy Participants
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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.

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

Another 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled for assessment over 16 weeks
Period Title: Overall Study
Started 41 [1] 36 [1]
Data Entry 41 36
Data Analyses 41 36
Submission for Publication 41 36
Completed 41 36
Not Completed 0 0
[1]
Started enrolling participants May 2009
Arm/Group Title Current Major Depressive Disorder Healthy Participants Total
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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).

Additional inclusion criteria specified that participants should be between ages 18 and 65 years, medically healthy, medication-free, and with no medication washout. Exclusion criteria included lifetime bipolar disorder, psychosis, obsessive-compulsive disorder, substance abuse/dependence, and several personality disorders (i.e., borderline, schizoid, schizotypal, antisocial).

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.

participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled for assessment over 16 weeks. Additional inclusion criteria specified that participants should be between ages 18 and 65 years, medically healthy, medication-free, and with no medication washout. Exclusion criteria included lifetime bipolar disorder, psychosis, obsessive-compulsive disorder, substance abuse/dependence, and several personality disorders (i.e., borderline, schizoid, schizotypal, antisocial).). Total of all reporting groups
Overall Number of Baseline Participants 41 36 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 36 participants 77 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
 100.0%
36
 100.0%
77
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 36 participants 77 participants
36  (12) 35  (14) 35  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 36 participants 77 participants
Female
26
  63.4%
20
  55.6%
46
  59.7%
Male
15
  36.6%
16
  44.4%
31
  40.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 36 participants 77 participants
41 36 77
1.Primary Outcome
Title 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.
Hide Description 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'.
Time Frame Week 16
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Hide Analysis Population Description
Intent to treat sample.
Arm/Group Title Current Major Depressive Disorder Healthy Participants
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Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA. DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).
An additional 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled
Overall Number of Participants Analyzed 41 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
14.1  (10.1) 2.7  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Current Major Depressive Disorder, Healthy Participants
Comments ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-C score at week 0) to estimate depression at the end of treatment (IDS-C score at week 16).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.42
Confidence Interval (2-Sided) 95%
0.27 to 0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title 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.
Hide Description 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'.
Time Frame Week 16
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Hide Analysis Population Description
Intent to treat sample.
Arm/Group Title Current Major Depressive Disorder Healthy Participants
Hide Arm/Group Description:
Forty-one participants with a primary diagnosis of major depression using the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA. DSM-IV) and scores > 24 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C; Rush et al., 1986).
An additional 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were enrolled
Overall Number of Participants Analyzed 41 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.9  (13.4) 3.0  (4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Current Major Depressive Disorder, Healthy Participants
Comments ANCOVA comparing groups (HEA v MDD), controlling for baseline depression (IDS-SR score at week 0) to estimate depression at the end of treatment (IDS-SR score at week 16).
Type of Statistical Test Superiority
Comments ANCOVA
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.31 to 0.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.07
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment
Hide Description 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).
Time Frame Week 0
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Current Major Depressive Disorder Healthy Participants
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participants diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID; First, Spitzer, Gibbon, & Williams, 2002) and a score > 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C; Rush et al., 2003; Rush et al., 1986).
Healthy participants were enrolled with no lifetime history or current presentation of psychiatric symptoms per the SCID and a score < 11 on the IDS-C.
Overall Number of Participants Analyzed 37 35
Mean (Standard Error)
Unit of Measure: Alpha power
0.43  (0.12) 0.16  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Current Major Depressive Disorder, Healthy Participants
Comments [Not Specified]
Type of Statistical Test Other
Comments Multiple regression analyses
Statistical Test of Hypothesis P-Value .02
Comments p <0.05 a priori threshold for statistical significance.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter beta
Estimated Value 0.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.75
Estimation Comments [Not Specified]
4.Primary Outcome
Title A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).
Hide Description 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.
Time Frame Weeks 0-16
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Hide Analysis Population Description
First level units were 'weeks in BA treatment', with participants limited to those diagnosed with MDD and who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'MDD subjects entering treatment' (n = 41)
Arm/Group Title Current Major Depressive Disorder
Hide Arm/Group Description:
participants diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID; First, Spitzer, Gibbon, & Williams, 2002) and a score > 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C; Rush et al., 2003; Rush et al., 1986).
Overall Number of Participants Analyzed 41
Geometric Least Squares Mean (Standard Error)
Unit of Measure: slope
-3.43  (0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Current Major Depressive Disorder
Comments A two-level hierarchical linear model assessing the effects of negativity bias and positivity offset at pre-treatment on the rate of depression severity (IDS-SR) over 16 weeks of treatment (time). First level units were 'weeks in BA treatment', with participants limited to those who attended five or more therapy sessions, resulting in a total of 421 treatment weeks for analysis. Second-level units were the 'subjects entering BA treatment'.
Type of Statistical Test Other
Comments Hierarchical linear modeling (HLM) , an ordinary least square (OLS) regression-based analysis.
Statistical Test of Hypothesis P-Value <0.05
Comments The variation of slopes among participants for each variable were calculated. If significant, a second level of analysis focused on predictors of the variation was conducted.
Method Regression, Logistic
Comments df = 31
Method of Estimation Estimation Parameter Slope
Estimated Value 2.58
Confidence Interval (2-Sided) 95%
1.22 to 2.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.75
Estimation Comments [Not Specified]
Time Frame Serious and Other (Not including Serious) Adverse Events were not collected/assessed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Current Major Depressive Disorder Healthy Participants
Hide Arm/Group Description Diagnosed with current major depressive disorder per the Structured Clinical Interview for the DSM-IV Axis I Disorders, (SCID) and a score ≥ 24 on the Inventory of Depressive Symptomatology-Clinician-Rated, (IDS-C). No lifetime history or current presentation of psychiatric symptoms per the SCID and a score ≤ 11 on the IDS-C.
All-Cause Mortality
Current Major Depressive Disorder Healthy Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Current Major Depressive Disorder Healthy Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Current Major Depressive Disorder Healthy Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jackie Gollan, Ph.D. Associate Professor of Psychiatry and Behavioral Sciences
Organization: Northwestern University
Phone: 312-695-6121
EMail: j-gollan@northwestern.edu
Layout table for additonal information
Responsible Party: Jacqueline Gollan, Northwestern University
ClinicalTrials.gov Identifier: NCT00909220     History of Changes
Other Study ID Numbers: R21MH082133 ( U.S. NIH Grant/Contract )
R21MH082133 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2009
First Posted: May 27, 2009
Results First Submitted: September 20, 2016
Results First Posted: January 16, 2018
Last Update Posted: April 17, 2018