ABMT Augmentation of CBT
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 3/15/2019 |
| Start Date: | February 1, 2017 |
| End Date: | January 2021 |
| Contact: | Daniel S Pine, M.D. |
| Email: | pined@mail.nih.gov |
| Phone: | (301) 594-1318 |
Attention Bias Modification Training as Augmentation of Cognitive Behavioral Therapy for Anxiety in Youth
This study examines a computer-based attention bias modification training as an augmentation
of individual cognitive behavioral therapy for pediatric anxiety.
All participants will receive interviews to assess how they are doing in general, including
general mood, degree of nervousness, and behavior. Each participant and one of his or her
parents will be interviewed separately and together. Participants are asked to complete tasks
involving problem-solving, attention, and emotion that involve looking at pictures,
remembering things, testing reaction times, and making simple choices.
Participants with anxiety will first meet with a psychologist for 12 weeks of individual
cognitive behavioral therapy. In addition, participants will be randomly and blindly assigned
to receive either an active computer-based attention bias modification training task or an
inactive/placebo version of this task, administered as part of their therapy treatment. The
active training is thought to help anxiety whereas the inactive training is thought to have
no effect.
The purpose of this part of the study is to understand the best way to help children and
adolescents who are having problems with anxiety. However, more research is needed to find
the best way to help such children and adolescents. During and after the treatment, each
participant will complete verbal and written symptom ratings.
Those who have not improved by the end of the study will be offered other treatment for 1 to
3 months, and the clinicians will help with finding subsequent aftercare. Those who improve
with treatment will continue therapy at NIH until an outside physician is able to assume
responsibility for monitoring medication.
FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645
of individual cognitive behavioral therapy for pediatric anxiety.
All participants will receive interviews to assess how they are doing in general, including
general mood, degree of nervousness, and behavior. Each participant and one of his or her
parents will be interviewed separately and together. Participants are asked to complete tasks
involving problem-solving, attention, and emotion that involve looking at pictures,
remembering things, testing reaction times, and making simple choices.
Participants with anxiety will first meet with a psychologist for 12 weeks of individual
cognitive behavioral therapy. In addition, participants will be randomly and blindly assigned
to receive either an active computer-based attention bias modification training task or an
inactive/placebo version of this task, administered as part of their therapy treatment. The
active training is thought to help anxiety whereas the inactive training is thought to have
no effect.
The purpose of this part of the study is to understand the best way to help children and
adolescents who are having problems with anxiety. However, more research is needed to find
the best way to help such children and adolescents. During and after the treatment, each
participant will complete verbal and written symptom ratings.
Those who have not improved by the end of the study will be offered other treatment for 1 to
3 months, and the clinicians will help with finding subsequent aftercare. Those who improve
with treatment will continue therapy at NIH until an outside physician is able to assume
responsibility for monitoring medication.
FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645
Objective: The goal of this protocol is to test the efficacy of a computer-based attention
bias modification training (comparing active vs. placebo) as an augmentation of individual
cognitive behavioral therapy for youth with anxiety disorders.
Study Population: A total of 120 children and adolescents (8-17 years old) will be recruited
to participate in this treatment trial.
Design: Participants' psychiatric symptoms and diagnoses will be assessed by clinical
interview. Participants will engage in 12 weeks of individual cognitive behavioral therapy in
addition to being randomized to receive either an active or placebo version of a
computer-based attention bias modification training.
Outcome Measures: The primary outcome measures to be examined are change in scores on the
Pediatric Anxiety Rating Scale and Clinical Global Impression Scale across treatment.
bias modification training (comparing active vs. placebo) as an augmentation of individual
cognitive behavioral therapy for youth with anxiety disorders.
Study Population: A total of 120 children and adolescents (8-17 years old) will be recruited
to participate in this treatment trial.
Design: Participants' psychiatric symptoms and diagnoses will be assessed by clinical
interview. Participants will engage in 12 weeks of individual cognitive behavioral therapy in
addition to being randomized to receive either an active or placebo version of a
computer-based attention bias modification training.
Outcome Measures: The primary outcome measures to be examined are change in scores on the
Pediatric Anxiety Rating Scale and Clinical Global Impression Scale across treatment.
Inclusion Criteria:
- Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of
the study will be eligible to complete all procedures completed by other subjects who
consent as 17- year- olds but do not turn 18).
- Consent: can give consent/assent (Parents will provide consent; minors will provide
assent)
- IQ: all subjects will have IQ > 70 (Assessment relies on WASI)
- Language: all subjects will speak English
Exclusion Criteria:
- Any serious medical condition or condition that interferes with fMRI scanning. (All
patients will have complete physical examination and history.
- Pregnancy
- Current use of any psychoactive substance; current suicidal ideation; current
diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to
require pharmacotherapy
- Current diagnoses Tourette's Disorder, OCD, post-traumatic distress disorder, conduct
disorder, major depressive disorder
- Past or current history of mania, psychosis, or severe pervasive developmental
disorder
- Recent use of an SSRI; all subjects must have been free of any SSRI-use for at least
one month (fluoxetine six months)
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