A Phase 2 interventional study of Computerized Information-Processing Bias Retraining and Attention Control Training in Major Depression, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 14 Years to 21 Years. Per ClinicalTrials.gov, last updated 2012-05-03.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 48 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Four sessions of positive information-processing training for interpretation of ambiguous scenarios relevant to themes of depression.
Behavioral: Computerized Information-Processing Bias Retraining
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.
Behavioral: Attention Control Training
The intervention consists of the presentation of three-line ambiguous scenarios via a computer program, one line at a time. A disambiguating word fragment completes the scenario (in either a positive or neutral valence, depending on the scenario), after which participants will type the first letter of the word on the keyboard to ensure they are encoding the interpretation valence. The computer will indicate if they have correctly identified the word. This is followed by a Y/N comprehension question. Each session presents 100 training scenarios.
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.
Test of Interpretation Bias (TIB)
The TIB consists of 10 scenarios, similar to the training scenarios except that the last word of all of the scenarios remains ambiguous in valence. Following exposure to each of these ambiguous scenarios, adolescents are given a series of four statements regarding the scenario and asked to rate on a 4-point scale how similar the statement is to their interpretation of the scenario. Two target statements are presented, one with the positive interpretation and one with the negative interpretation. Scores for negative and positive interpretations across the situations can then be calculated.
Time frame: up to 1 day post-treatment
Test of Interpretation Bias
See above
Time frame: 2-Week Follow-Up
Kiddie-Schedule of Affective Disorders and Schizophrenia-Epidemiologic Version (K-SADS-E; Orvaschek & Puig-Antich, 1987)
DSM-IV structured interview for children up to age 16 years old; assesses for major depression, dysthymia, and mania.
Time frame: up to one day Post-Treatment and at 2-Week Follow-Up
Beck Depression Inventory, 2nd Version
The BDI-II is a questionnaire the measures symptoms of depression over the previous two weeks.
Time frame: up to 1 day Post-Treatment and at 2-Week Follow-Up
State-Trait Anxiety Scale (STAI)
The STAI is a self-report measure of anxiety symptoms over the past week (trait) and currently (state).
Time frame: up to 1 day Post-Treatment and 2-Week Follow-Up
Structured Clinical Interview for DSM-IV (SCID-IV; First et al, 1997), Mood Disorder Modules only
DSM-IV structured interview for adults (17 years old and older); assesses for major depression, dysthymia, and mania
Time frame: up to 1 day Post-Treatment and 2-Week Follow-Up
Dysfunctional Attitudes Scale (DAS)
The DAS-A is a 40-item self-report measure of depressogenic beliefs. The scale has two factors: Perfectionism and Need for Social Approval (Imber et al., 1990). Internal consistency and concurrent validity have been found to be acceptable (Imber et al, 1990; Blatt et al, 1995).
Time frame: up to 1 day post-treatment and at two-week follow-up
CANTAB Affective Go-No Go Task (AGN)
The AGN test assesses information processing biases for positive and negative stimuli and takes 10 minutes to administer. The test consists of several blocks, each of which presents a series of words from two of three different Affective categories: Positive (for example, joyful), Negative (for example, hopeless), and Neutral (for example, element). The subject is given a target category, and is asked to press the press pad when they see a word matching this category. There are twelve outcome measures covering latency and errors of commission and omission.
Time frame: up to 1 day post-treatment
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital