Computerized Information-Processing Bias Retraining in Depressed Adolescents

NCT01147913 | Completed Phase 2 DMC

• 1 other identifier: F32MH088065-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

Major Depression; Depression; Anxiety; Dysthymia

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 1 day post-treatment

• Test of Interpretation Bias

  See above

  2-Week Follow-Up

Secondary Outcomes (6)

• Kiddie-Schedule of Affective Disorders and Schizophrenia-Epidemiologic Version (K-SADS-E; Orvaschek & Puig-Antich, 1987)

  up to one day Post-Treatment and at 2-Week Follow-Up

• Beck Depression Inventory, 2nd Version

  up to 1 day Post-Treatment and at 2-Week Follow-Up

• State-Trait Anxiety Scale (STAI)

  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

  up to 1 day Post-Treatment and 2-Week Follow-Up

• Dysfunctional Attitudes Scale (DAS)

  up to 1 day post-treatment and at two-week follow-up

Study Arms (2)

Positive Interpretation Training

EXPERIMENTAL

Four sessions of positive information-processing training for interpretation of ambiguous scenarios relevant to themes of depression.

Behavioral: Computerized Information-Processing Bias Retraining

Attention Control Training

SHAM COMPARATOR

Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.

Behavioral: Attention Control Training

Interventions

Computerized Information-Processing Bias Retraining BEHAVIORAL

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.

Positive Interpretation Training

Attention Control Training BEHAVIORAL

Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.

Attention Control Training

Eligibility Criteria

• Age: 14 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Anxiety Disorders; Dysthymic Disorder

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jamie A Micco, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Psychology

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 3, 2012

Record last verified: 2012-05

Locations

US (1)