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

Northwestern University

Status: Completed

Conditions: Depression

Treatments: Behavioral: Behavioral Activation

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00909220

R21MH082133 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

77 participants in 2 patient groups

Current Major Depressive Disorder

Description:

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.

Treatment:

Behavioral: Behavioral Activation

Healthy Participants

Description:

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