ABMT Augmentation of CBT
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active ABMT Active attention bias modification will be provided in addition to individual cognitive behavioral therapy |
Behavioral: Active Attention Bias Modification Training
Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
|
| Placebo Comparator: Placebo Placebo attention bias modification will be provided in addition to individual cognitive behavioral therapy |
Behavioral: Placebo Attention Bias Modification Training
Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases
|
Outcome Measures
Primary Outcome Measures
- The Pediatric Anxiety Rating Scale (PARS) [Every 4 weeks]
- Clinical Global Impression Scale (CGI) [Weekly]
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NIH Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institutes of Health Clinical Center (CC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Britton JC, Suway JG, Clementi MA, Fox NA, Pine DS, Bar-Haim Y. Neural changes with attention bias modification for anxiety: a randomized trial. Soc Cogn Affect Neurosci. 2015 Jul;10(7):913-20. doi: 10.1093/scan/nsu141. Epub 2014 Oct 24.
- White LK, Sequeira S, Britton JC, Brotman MA, Gold AL, Berman E, Towbin K, Abend R, Fox NA, Bar-Haim Y, Leibenluft E, Pine DS. Complementary Features of Attention Bias Modification Therapy and Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders. Am J Psychiatry. 2017 Aug 1;174(8):775-784. doi: 10.1176/appi.ajp.2017.16070847. Epub 2017 Apr 14. Erratum in: Am J Psychiatry. 2018 Jan 1;175(1):83.
- 0192A