Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital
Cambridge, Massachusetts, 02138, United States
NCT Number: NCT01147913
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.
Looking for future studies?
Notify Me14 year–21 year
All sexes
Interventional
Phase 2
Cambridge, Massachusetts, 02138, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: up to 1 day post-treatment
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: 2-Week Follow-Up
See above
Time frame: up to one day Post-Treatment and at 2-Week Follow-Up
DSM-IV structured interview for children up to age 16 years old; assesses for major depression, dysthymia, and mania.
Time frame: up to 1 day Post-Treatment and at 2-Week Follow-Up
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 2-Week Follow-Up
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
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 at two-week follow-up
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
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.
Massachusetts General Hospital
Other
Computerized Information-Processing Bias Retraining in Adolescents With Depression: A Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07181226
Anxiety Disorders, Behavior
Most, Ústí nad Labem Region, Czechia
View Trial DetailsNCT01132872
Anxiety Disorder, Anxiety Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT01566318
Anxiety Disorder, Anxiety Disorders
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT00982345
Anxiety Disorders, Behavior
Indianapolis, Indiana, United States
View Trial Details