Clinical trial NCT01147913: Computerized Information-Processing Bias Retraining in Depressed Adolescents
Official title: Computerized Information-Processing Bias Retraining in Adolescents With Depression: A Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depression
Keywords: Major Depression
Depression
Anxiety
Dysthymia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine how well a novel four-session computerized program, designed to help adolescents learn to interpret ambiguous situations less negatively, reduces symptoms of depression and decreases negative information-processing biases.

Detailed description: Major Depression is a markedly impairing disorder that affects up to 20% of adolescents before adulthood, and is associated with significant impairment in adolescents' emotional and social development. While antidepressant medication and psychotherapy are effective in treating some depressed adolescents, approximately 30% fail to respond to a combination of these treatments. Furthermore, many families are reluctant to pursue antidepressant medication for depressed adolescents because of concerns about potentially increasing risk of suicidal ideation. Thus, there is a critical need for effective, non-pharmacological treatments for this population. One promising new intervention consists of modifying negative information-processing biases associated with depression. Recent research has suggested that these biases may be modified using a computerized program that provides repeated exposure to positive interpretations of salient, ambiguous situations, with the goal of interpreting ambiguity less negatively. These modification programs have been efficacious in altering interpretation biases and reducing anxiety in adults with social and specific phobias. Therefore, the proposed study aims to examine the efficacy of an adapted interpretation bias modification program for depressed adolescents. Specifically, the study will examine the efficacy of four sessions of the modification program in altering interpretation biases and reducing symptoms of depression, anxiety, and negative affect. A total of 60 adolescents (ages 14-21) with symptoms of major depression will be randomly assigned to either the active intervention condition (four sessions of the modification program over two weeks) or an attention control condition. Measures will include a diagnostic interview, self-report measures of depression, anxiety, and negative affect, and a test of interpretation bias in response to ambiguous situations. It is hypothesized that: 1) Compared to adolescents in the attention control condition, adolescents who receive four sessions of the positive interpretive training will experience a significantly larger decrease from baseline to post-treatment in negative interpretation bias (e.g., more positive and fewer negative interpretations of ambiguous situations) on a measure of interpretation bias; and, 2)Compared to adolescents in the attention control condition, adolescents who receive the positive interpretation training will experience a significantly larger decrease from baseline to post-treatment in self-reported state depression, anxiety, and negative affect.

Eligibility criteria: Inclusion Criteria:

* Participants must be between 14-21 years old
* A score of 14 or higher on the Beck Depression Inventory, 2nd Edition (BDI-II)
* Working command of the English language

Exclusion Criteria:

* Psychosis, current mania, or acute suicidality
* Previous diagnosis of pervasive developmental disorder, mental retardation, or severe dyslexia
* Changes in psychiatric medication or psychotherapy within two weeks of entering the study

Primary outcomes:
measure: Test of Interpretation Bias (TIB)
timeFrame: up to 1 day post-treatment
measure: Test of Interpretation Bias
timeFrame: 2-Week Follow-Up
Secondary outcomes:
measure: Kiddie-Schedule of Affective Disorders and Schizophrenia-Epidemiologic Version (K-SADS-E; Orvaschek & Puig-Antich, 1987)
timeFrame: up to one day Post-Treatment and at 2-Week Follow-Up
measure: Beck Depression Inventory, 2nd Version
timeFrame: up to 1 day Post-Treatment and at 2-Week Follow-Up
measure: State-Trait Anxiety Scale (STAI)
timeFrame: up to 1 day Post-Treatment and 2-Week Follow-Up
measure: Structured Clinical Interview for DSM-IV (SCID-IV; First et al, 1997), Mood Disorder Modules only
timeFrame: up to 1 day Post-Treatment and 2-Week Follow-Up
measure: Dysfunctional Attitudes Scale (DAS)
timeFrame: up to 1 day post-treatment and at two-week follow-up
measure: CANTAB Affective Go-No Go Task (AGN)
timeFrame: up to 1 day post-treatment
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jamie A Micco, PhD
role: PRINCIPAL_INVESTIGATOR
References: