Computerized Information-Processing Bias Retraining in Depressed Adolescents

May 2, 2012 updated by: Jamie A. Micco, PhD, Massachusetts General Hospital

Computerized Information-Processing Bias Retraining in Adolescents With Depression: A Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02138
        • Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Positive Interpretation Training
Four sessions of positive information-processing training for interpretation of ambiguous scenarios relevant to themes of depression.
Behavioral: Computerized Information-Processing Bias Retraining
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.
SHAM_COMPARATOR: Attention Control Training
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.
Behavioral: Attention Control Training
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Test of Interpretation Bias (TIB)
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.
up to 1 day post-treatment
Test of Interpretation Bias
Time Frame: 2-Week Follow-Up
See above
2-Week Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Kiddie-Schedule of Affective Disorders and Schizophrenia-Epidemiologic Version (K-SADS-E; Orvaschek & Puig-Antich, 1987)
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.
up to one day Post-Treatment and at 2-Week Follow-Up
Beck Depression Inventory, 2nd Version
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.
up to 1 day Post-Treatment and at 2-Week Follow-Up
State-Trait Anxiety Scale (STAI)
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).
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
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
up to 1 day Post-Treatment and 2-Week Follow-Up
Dysfunctional Attitudes Scale (DAS)
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).
up to 1 day post-treatment and at two-week follow-up
CANTAB Affective Go-No Go Task (AGN)
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.
up to 1 day post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jamie A Micco, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F32MH088065-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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