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Computerized Information-Processing Bias Retraining in Depressed Adolescents

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Computerized Information-Processing Bias Retraining
Attention Control Training
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Depression, Anxiety, Dysthymia

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Positive Interpretation Training

Attention Control Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Test of Interpretation Bias
See above

Secondary Outcome Measures

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.
Beck Depression Inventory, 2nd Version
The BDI-II is a questionnaire the measures symptoms of depression over the previous two weeks.
State-Trait Anxiety Scale (STAI)
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
DSM-IV structured interview for adults (17 years old and older); assesses for major depression, dysthymia, and mania
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).
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.

Full Information

First Posted
April 12, 2010
Last Updated
May 2, 2012
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01147913
Brief Title
Computerized Information-Processing Bias Retraining in Depressed Adolescents
Official Title
Computerized Information-Processing Bias Retraining in Adolescents With Depression: A Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major Depression, Depression, Anxiety, Dysthymia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Interpretation Training
Arm Type
Experimental
Arm Description
Four sessions of positive information-processing training for interpretation of ambiguous scenarios relevant to themes of depression.
Arm Title
Attention Control Training
Arm Type
Sham Comparator
Arm Description
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.
Intervention Type
Behavioral
Intervention Name(s)
Computerized Information-Processing Bias Retraining
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control Training
Intervention Description
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.
Primary Outcome Measure Information:
Title
Test of Interpretation Bias (TIB)
Description
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
Title
Test of Interpretation Bias
Description
See above
Time Frame
2-Week Follow-Up
Secondary Outcome Measure Information:
Title
Kiddie-Schedule of Affective Disorders and Schizophrenia-Epidemiologic Version (K-SADS-E; Orvaschek & Puig-Antich, 1987)
Description
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
Title
Beck Depression Inventory, 2nd Version
Description
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
Title
State-Trait Anxiety Scale (STAI)
Description
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
Title
Structured Clinical Interview for DSM-IV (SCID-IV; First et al, 1997), Mood Disorder Modules only
Description
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
Title
Dysfunctional Attitudes Scale (DAS)
Description
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
Title
CANTAB Affective Go-No Go Task (AGN)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie A Micco, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

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