Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
|ClinicalTrials.gov Identifier: NCT00909220|
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : January 16, 2018
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment|
|Depression||Behavioral: Behavioral Activation|
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 Type :||Observational|
|Actual Enrollment :||77 participants|
|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|
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).
Another 36 participants with no lifetime psychiatric symptoms and scores < 11 on the IDS-C were tracked prospectively, naturalistically, for 16 weeks.
- 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'.
- 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'.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909220
|Principal Investigator:||Jacqueline K. Gollan, PhD||Northwestern University|