Major DepressionPhase 2NCT01147913
Computerized Information-Processing Bias Retraining in Depressed Adolescents
A Phase 2 study testing Computerized Information-Processing Bias Retraining in people with Major Depression, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Computerized Information-Processing Bias Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Research Program in Pediatric Psychopharmacology at Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: 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.
Read the 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.
- Conditions
- Major Depression
- Being tested
- Computerized Information-Processing Bias Retraining, Attention Control Training
- Keywords
- Major Depression, Depression, Anxiety, Dysthymia
- Medical subject headings
- Depressive Disorder, Major, Depression, Anxiety Disorders, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Information-Processing Bias RetrainingBehavioural
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 TrainingBehavioural
Four sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression.
| Study group | Role | What they receive |
|---|---|---|
| Positive Interpretation Training | Experimental | Four sessions of positive information-processing training for interpretation of ambiguous scenarios relevant to themes of depression. Receives: 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. Receives: Behavioral: Attention Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 day post-treatment
Test of Interpretation Bias
See above
Measured: 2-Week Follow-Up
Secondary outcomes (6)
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.
Measured: up to one day Post-Treatment and at 2-Week Follow-Up
Beck Depression Inventory, 2nd Version
The BDI-II is a questionnaire the measures symptoms of depression over the previous two weeks.
Measured: up to 1 day Post-Treatment and at 2-Week Follow-Up
State-Trait Anxiety Scale (STAI)
The STAI is a self-report measure of anxiety symptoms over the past week (trait) and currently (state).
Measured: 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
DSM-IV structured interview for adults (17 years old and older); assesses for major depression, dysthymia, and mania
Measured: up to 1 day Post-Treatment and 2-Week Follow-Up
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).
Measured: up to 1 day post-treatment and at two-week follow-up
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.
Measured: up to 1 day post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie A. Micco, PhD, Massachusetts General Hospital
- Investigators
- Jamie A Micco, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147913
- Sponsor's protocol ID
- F32MH088065-01
- Status last verified
- May 2012
- First submitted
- 12 Apr 2010
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Information-Processing Bias Retraining in Adolescents With Depression: A Controlled Trial
- ClinicalTrials.gov ID
- NCT01147913
- Acronym / sponsor ID
- F32MH088065-01
- Conditions
- Major Depression
- Keywords
- Major Depression, Depression, Anxiety, Dysthymia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Interpretation Training | Experimental | Behavioral: Computerized Information-Processing Bias RetrainingFour sessions of positive information-processing training for interpretation of ambiguous scenarios relevant to themes of depression. |
| Attention Control Training | Sham comparator | Behavioral: Attention Control TrainingFour sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Information-Processing Bias RetrainingThe 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. | Behavioural | Positive Interpretation Training |
| Attention Control TrainingFour sessions of interpretation training for "filler" or neutral scenarios, unrelated to themes associated with depression. | Behavioural | Attention Control Training |
Primary outcome
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.
Test of Interpretation Bias
Time frame: 2-Week Follow-Up
See above
6 secondary outcomes
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
Beck Depression Inventory, 2nd Version
Time frame: 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
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
Dysfunctional Attitudes Scale (DAS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie A Micco, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computerized Information-Processing Bias Retraining in people with Major Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Interpretation Bias (TIB) (time frame: up to 1 day post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.