N/A
N=77
Using Affective Differences to Predict Response to Behavioral Treatment for Major Depressive Disorder
Depression
Bottom Line
View on ClinicalTrials.gov: NCT00909220 ↗Enrolled (actual)
77
Serious AEs
—
Results posted
Jan 2018
Primary outcome: Primary: 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; 2.7 units on a scale — p=0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Behavioral Activation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 2.7 | 0.05 |
| PRIMARY 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; 3.0 | <0.05 sig |
| PRIMARY Pre-treatment Frontal EEG Asymmetry Score as a Predictor of Negative Affect at Post-treatment |
0.43; 0.16 | .02 sig |
| PRIMARY 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 | <0.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00909220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.