Trial Outcomes & Findings for Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder (NCT NCT00909220)
NCT ID: NCT00909220
Last Updated: 2018-04-17
Results Overview
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'.
COMPLETED
77 participants
Week 16
2018-04-17
Participant Flow
Participants from each group were recruited from the same community locations via advertisements and the internet. Enrollment began 5/2009 and ended 7/2011.
All depressed participants were enrolled into the Behavioral Activation Treatment arm. All healthy participants were tracked for the duration of the study.
Participant milestones
| Measure |
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.
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
|
Healthy Participants
Another 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were enrolled for assessment over 16 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
36
|
|
Overall Study
Data Entry
|
41
|
36
|
|
Overall Study
Data Analyses
|
41
|
36
|
|
Overall Study
Submission for Publication
|
41
|
36
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
Current Major Depressive Disorder
n=41 Participants
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.
|
Healthy Participants
n=36 Participants
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
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 12 • n=99 Participants
|
35 years
STANDARD_DEVIATION 14 • n=107 Participants
|
35 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
36 participants
n=107 Participants
|
77 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: Intent to treat sample.
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'.
Outcome measures
| Measure |
Current Major Depressive Disorder
n=41 Participants
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).
|
Healthy Participants
n=36 Participants
An additional 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were enrolled
|
|---|---|---|
|
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.
|
14.1 units on a scale
Standard Deviation 10.1
|
2.7 units on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Week 16Population: Intent to treat sample.
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'.
Outcome measures
| Measure |
Current Major Depressive Disorder
n=41 Participants
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).
|
Healthy Participants
n=36 Participants
An additional 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were enrolled
|
|---|---|---|
|
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.
|
16.9 units on a scale
Standard Deviation 13.4
|
3.0 units on a scale
Standard Deviation 4.6
|
PRIMARY outcome
Timeframe: Week 0Frontal 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).
Outcome measures
| Measure |
Current Major Depressive Disorder
n=37 Participants
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).
|
Healthy Participants
n=35 Participants
An additional 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were enrolled
|
|---|---|---|
|
Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment
|
0.43 Alpha power
Standard Error 0.12
|
0.16 Alpha power
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Weeks 0-16Population: 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)
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.
Outcome measures
| Measure |
Current Major Depressive Disorder
n=41 Participants
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).
|
Healthy Participants
An additional 36 participants with no lifetime psychiatric symptoms and scores \< 11 on the IDS-C were enrolled
|
|---|---|---|
|
A Two Level Hierarchical Model Testing the Association Between Negativity Bias Change During BA Treatment With Patient-reported Depression Severity (Week 16 IDS-SR).
|
-3.43 slope
Standard Error 0.75
|
—
|
Adverse Events
Current Major Depressive Disorder
Healthy Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jackie Gollan, Ph.D. Associate Professor of Psychiatry and Behavioral Sciences
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place