Generalized Anxiety DisorderNCT01906268
Attention Retraining for Anxiety Disorder Patients Resistent to Antidepressants
A study testing Attentional Bias Modification Treatment (ABMT) - Active in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Attentional Bias Modification Treatment (ABMT) - Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Generalized Anxiety Disorder, Panic Disorder or Social Anxiety Disorder according to the International Neuropsychiatric Interview psychiatric interview (M.I.N.I.)
- Current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks;
- Score on OASIS (Overall Anxiety Severity and Impairment Scale)equal or greater than 8
Who cannot join
- Other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation
- Current Cognitive Behavior Therapy
- Marked intellectual disability (clinically evident)
- Suicidal ideation or suicide plan at the time of assessment(M.I.N.I.)
- Psychotic disorder (M.I.N.I.)
- Bipolar disorder type I (M.I.N.I.)
- Abuse / Dependence substances (M.I.N.I.)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90040-371
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90040-371
Rachel Montagner, MD
Giovanni A Salum Junior
About this study
Official title: Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.
- Being tested
- Attentional Bias Modification Treatment (ABMT) - Active, Attentional Bias Modification Treatment - Placebo
- Keywords
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Antidepressants Resistant, Attentional Bias Modification Treatment (ABMT), Attentional Retraining, Adjuvant Therapy
- Medical subject headings
- Generalized Anxiety Disorder, Phobia, Social, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attentional Bias Modification Treatment (ABMT) - ActiveOther
The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.
Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)
Attentional Bias Modification Treatment - PlaceboOther
The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.
Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)
| Study group | Role | What they receive |
|---|---|---|
| TAU + ABMT active | Experimental | Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor
Attention Bias Modification Treatment (ABMT) - active Receives: Other: Attentional Bias Modification Treatment (ABMT) - Active |
| TAU + AMBT placebo | Sham comparator | Treatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor
Attention Bias Modification Treatment (ABMT) - placebo (sham) Receives: Other: Attentional Bias Modification Treatment - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Anxiety Severity and Impairment Scale (OASIS)
Disorder non-specific primary outcome:
Score change on OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to endpoint and 3-months follow-up
Measured: Endpoint and 3-months follow-up
Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)
Disorder-specific primary outcome:
For patients with Panic Disorder - change from baseline to endpoint and 3 months follow-up in the PDSS
For patients with Generalized Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the GAD-7
For patients with Social Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the LSAS
Measured: Endpoint and 3-months follow up
Secondary outcomes (5)
Beck Depression Inventory (BDI)
Score change on BDI from baseline to endpoint and 3-months follow up
Measured: Endpoint and 3-months follow-up
Beck Anxiety Inventory (BAI)
Score change on BAI from baseline to endpoint and 3-months follow up
Measured: Endpoint and 3-months follow-up
DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]
Score change on Cross-D from baseline to endpoint and 3-months follow up
Measured: Endpoint and 3-months follow-up
Profile of Mood States (POMS)
Score Change on POMS from baseline to endpoint and 3-months follow up.
Measured: Endpoint and 3-months follow-up
Clinical Global Impression(CGI)
Dichotomous outcome: percentage of patients with a score of 2 or less at the endpoint and 3-months follow-up evaluations
Measured: Endpoint and 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisele G Manfro, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906268
- Sponsor's protocol ID
- 13-0338
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2013
- Last updated
- 21 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Bias Modification Treatment (ABMT) as Adjuvant Therapy for Anxiety Disorder Patients Resistent to Antidepressants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01906268
- Acronym / sponsor ID
- 13-0338
- Keywords
- Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Antidepressants Resistant, Attentional Bias Modification Treatment (ABMT), Attentional Retraining, Adjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 24 Jul 2013 (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.
The objective of this project is to test the combination of active or placebo Attentional Bias Modification Treatment (ABMT) to usual treatment for anxiety disorder patients resistant to antidepressants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAU + ABMT active | Experimental | Other: Attentional Bias Modification Treatment (ABMT) - ActiveTreatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor Attention Bias Modification Treatment (ABMT) - active |
| TAU + AMBT placebo | Sham comparator | Other: Attentional Bias Modification Treatment - PlaceboTreatment as usual (TAU): selective serotonin reuptake inhibitor or serotonin norepinephrine reuptake inhibitor Attention Bias Modification Treatment (ABMT) - placebo (sham) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of Generalized Anxiety Disorder, Panic Disorder or Social Anxiety Disorder according to the International Neuropsychiatric Interview psychiatric interview (M.I.N.I.)
- Current treatment for the anxiety disorder with antidepressants with an appropriate dose for at least 8 weeks;
- Score on OASIS (Overall Anxiety Severity and Impairment Scale)equal or greater than 8
Key exclusion criteria (7 listed)
- Other psychiatric disorder that causes more impairment and suffering than generalized anxiety disorder, panic disorder or social anxiety disorder in the clinical evaluation
- Current Cognitive Behavior Therapy
- Marked intellectual disability (clinically evident)
- Suicidal ideation or suicide plan at the time of assessment(M.I.N.I.)
- Psychotic disorder (M.I.N.I.)
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 |
|---|---|---|
| Attentional Bias Modification Treatment (ABMT) - ActiveThe ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor. Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval) | Other | TAU + ABMT active |
| Attentional Bias Modification Treatment - PlaceboThe Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation. Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval) | Other | TAU + AMBT placebo |
Primary outcome
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: Endpoint and 3-months follow-up
Disorder non-specific primary outcome: Score change on OASIS (Overall Anxiety Severity and Impairment Scale) from baseline to endpoint and 3-months follow-up
Panic Disorder Severity Scale (PDSS), Generalized Anxiety Disorder 7-item Scale (GAD-7) or Liebowitz Social Anxiety Scale (LSAS)
Time frame: Endpoint and 3-months follow up
Disorder-specific primary outcome: For patients with Panic Disorder - change from baseline to endpoint and 3 months follow-up in the PDSS For patients with Generalized Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the GAD-7 For patients with Social Anxiety Disorder - change from baseline to endpoint and 3 months follow-up in the LSAS
5 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Endpoint and 3-months follow-up
Beck Anxiety Inventory (BAI)
Time frame: Endpoint and 3-months follow-up
DSM-5 Cross-Disorder Dimensional Scale [Brazilian version]
Time frame: Endpoint and 3-months follow-up
Profile of Mood States (POMS)
Time frame: Endpoint and 3-months follow-up
Clinical Global Impression(CGI)
Time frame: Endpoint and 3-months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
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.
Gisele G Manfro, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attentional Bias Modification Treatment (ABMT) - Active in people with Generalized Anxiety Disorder and Social Anxiety Disorder, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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 7 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: status not confirmed, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Montagner, MD (+55 51 3359 8983, rachelmontagner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Anxiety Severity and Impairment Scale (OASIS) (time frame: Endpoint and 3-months follow-up). 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 21 Jul 2014.