Computerized Information-Processing Bias Retraining in Depressed Adolescents

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147913
• Other study ID #: F32MH088065-01
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: May 2, 2012
• Start date: March 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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

Locations

Country	Name	City	State
United States	Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Test of Interpretation Bias	See above	2-Week Follow-Up	No
Secondary	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.	up to one day Post-Treatment and at 2-Week Follow-Up	No
Secondary	Beck Depression Inventory, 2nd Version	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	No
Secondary	State-Trait Anxiety Scale (STAI)	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	No
Secondary	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	up to 1 day Post-Treatment and 2-Week Follow-Up	No
Secondary	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).	up to 1 day post-treatment and at two-week follow-up	No
Secondary	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.	up to 1 day post-treatment	No