Computerized Information-Processing Bias Retraining in Depressed Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jamie A. Micco, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01147913
First received: April 12, 2010
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Major Depression
Behavioral: Computerized Information-Processing Bias Retraining
Behavioral: Attention Control Training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computerized Information-Processing Bias Retraining in Adolescents With Depression: A Controlled Trial

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Test of Interpretation Bias (TIB) [ Time Frame: up to 1 day post-treatment ] [ Designated as safety issue: No ]
    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.

  • Test of Interpretation Bias [ Time Frame: 2-Week Follow-Up ] [ Designated as safety issue: No ]
    See above


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    DSM-IV structured interview for children up to age 16 years old; assesses for major depression, dysthymia, and mania.

  • Beck Depression Inventory, 2nd Version [ Time Frame: up to 1 day Post-Treatment and at 2-Week Follow-Up ] [ Designated as safety issue: No ]
    The BDI-II is a questionnaire the measures symptoms of depression over the previous two weeks.

  • State-Trait Anxiety Scale (STAI) [ Time Frame: up to 1 day Post-Treatment and 2-Week Follow-Up ] [ Designated as safety issue: No ]
    The STAI is a self-report measure of anxiety symptoms over the past week (trait) and currently (state).

  • 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 ] [ Designated as safety issue: No ]
    DSM-IV structured interview for adults (17 years old and older); assesses for major depression, dysthymia, and mania

  • Dysfunctional Attitudes Scale (DAS) [ Time Frame: up to 1 day post-treatment and at two-week follow-up ] [ Designated as safety issue: No ]
    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).

  • CANTAB Affective Go-No Go Task (AGN) [ Time Frame: up to 1 day post-treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 48
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147913

Locations
United States, Massachusetts
Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jamie A Micco, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jamie A. Micco, PhD, Assistant in Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01147913     History of Changes
Other Study ID Numbers: F32MH088065-01
Study First Received: April 12, 2010
Last Updated: May 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Major Depression
Depression
Anxiety
Dysthymia

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014