Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder
NCT ID: NCT02210728
Last Updated: 2018-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2006-04-30
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medication only
Stimulant medication (methylphenidate or amphetamine product approved for clinical use in Canada), with dose optimized for each patient based on report of efficacy and side effects.
methylphenidate or amphetamine product
Medication is titrated over a 4-week period with stepwise increments each week. Patients and significant others complete ADHD symptom scales at baseline and before each medication visit. Patients also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the subjects remain on this dose for the remainder of the study.
Cognitive behavioral therapy + medication
Patients are first titrated to an optimal dose of stimulant medication. They then undergo the 12 weeks of group cognitive behavioral therapy.
methylphenidate or amphetamine product
Medication is titrated over a 4-week period with stepwise increments each week. Patients and significant others complete ADHD symptom scales at baseline and before each medication visit. Patients also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the subjects remain on this dose for the remainder of the study.
Cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy. Participants also receive individual coaching 3 times a week (twice over telephone and once in person). Coaching sessions are 15 minutes each in duration and are aimed at implementation, practice, and generalization of skills acquired in therapy.
Cognitive behavioral therapy alone
12 weeks of structured group cognitive behavioral therapy, focusing on acquisition of skills in organization, time management, goal attainment, cognitive restructuring, stress management, anger management, impulse control, self-esteem, and relationship management.
Cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy. Participants also receive individual coaching 3 times a week (twice over telephone and once in person). Coaching sessions are 15 minutes each in duration and are aimed at implementation, practice, and generalization of skills acquired in therapy.
Interventions
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methylphenidate or amphetamine product
Medication is titrated over a 4-week period with stepwise increments each week. Patients and significant others complete ADHD symptom scales at baseline and before each medication visit. Patients also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the subjects remain on this dose for the remainder of the study.
Cognitive behavioral therapy
12 sessions of group cognitive behavioral therapy. Participants also receive individual coaching 3 times a week (twice over telephone and once in person). Coaching sessions are 15 minutes each in duration and are aimed at implementation, practice, and generalization of skills acquired in therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Barkley Childhood and Current Symptom of ADHD (1998) completed by self and informants (parents or siblings). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
* Conners' Adult ADHD Rating Scale (1999). Required cut off's on these scales are scores 1.5 Standard Deviation above relevant gender and age norms;
* Between 18 and 60 years old
* Be able to give informed consent and comply with study procedures;
* I.Q. of 80 or above on Wechsler Adult Intelligence Scale, 3rd edition (WAIS-III) subtests of three verbal and three nonverbal subtests
* Adequate command of English to be able to participate in CBT group.
Exclusion Criteria
* Current psychiatric comorbidity, e.g. bipolar disorder, depression, suicidality, current substance use disorder (must be free of substance abuse for 6 months)
* Medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, Tourette's Syndrome, etc.
* Organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis, deafness, blindness.
18 Years
60 Years
ALL
No
Sponsors
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Lily Hechtman
OTHER
Responsible Party
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Lily Hechtman
Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry
Principal Investigators
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Lily Hechtman, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
McGill University Health Centre/Research Institute of the McGill University Health Centre
Locations
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Montreal Children's Hospital
Montreal, Quebec, Canada
Countries
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References
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Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716-23. doi: 10.1176/ajp.2006.163.4.716.
Safren SA. Cognitive-behavioral approaches to ADHD treatment in adulthood. J Clin Psychiatry. 2006;67 Suppl 8:46-50.
Wilens TE, Spencer TJ, Biederman J. A review of the pharmacotherapy of adults with attention-deficit/hyperactivity disorder. J Atten Disord. 2002 Mar;5(4):189-202. doi: 10.1177/108705470100500401.
Bramham J, Young S, Bickerdike A, Spain D, McCartan D, Xenitidis K. Evaluation of group cognitive behavioral therapy for adults with ADHD. J Atten Disord. 2009 Mar;12(5):434-41. doi: 10.1177/1087054708314596. Epub 2008 Feb 29.
Gualtieri CT, Ondrusek MG, Finley C. Attention deficit disorders in adults. Clin Neuropharmacol. 1985;8(4):343-56. doi: 10.1097/00002826-198512000-00005.
Knouse LE, Cooper-Vince C, Sprich S, Safren SA. Recent developments in the psychosocial treatment of adult ADHD. Expert Rev Neurother. 2008 Oct;8(10):1537-48. doi: 10.1586/14737175.8.10.1537.
Mattes JA, Boswell L, Oliver H. Methylphenidate effects on symptoms of attention deficit disorder in adults. Arch Gen Psychiatry. 1984 Nov;41(11):1059-63. doi: 10.1001/archpsyc.1983.01790220049008.
Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD. Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123. Epub 2010 Mar 15.
Spencer T, Biederman J, Wilens T, Doyle R, Surman C, Prince J, Mick E, Aleardi M, Herzig K, Faraone S. A large, double-blind, randomized clinical trial of methylphenidate in the treatment of adults with attention-deficit/hyperactivity disorder. Biol Psychiatry. 2005 Mar 1;57(5):456-63. doi: 10.1016/j.biopsych.2004.11.043.
Weiss, G., & Hechtman, L. (1993). Hyperactive children grown up : ADHD in children, adolescents, and adults (2nd ed.). New York: Guilford Press.
Barkley, R. A., Murphy, K. R., & Firscher, M. (2008). ADHD in adults: What the Science Says. New York: Guilford Press
Hechtman, L., Treatment of adults with adhd: Cbt only versus medication and cbt, in Third International Congress on ADHD - From Childhood to Adolescence. 2011: Berlin, Germany.
Other Identifiers
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PED-06-002
Identifier Type: -
Identifier Source: org_study_id
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