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Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder

Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

Intervention: methylphenidate or amphetamine product (Drug); Cognitive behavioral therapy (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Lily Hechtman

Official(s) and/or principal investigator(s):
Lily Hechtman, MD, FRCPC, Principal Investigator, Affiliation: McGill University Health Center

Overall contact:
Tara Errington, MSc, Phone: 514-412-4400, Ext: 23286, Email: adhd.research.adult@gmail.com

Summary

The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant medication and compare it to medication alone. Subjects will be randomly assigned to stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients will be evaluated at baseline, following mediation optimization (for medicated groups), following 12 months of treatment, after 3 months of follow up, and after 6 months of follow up. The investigators hypothesize that the combined group will have the best outcome at all evaluation points. ADHD in adults is associated with significant morbidity and impaired academic, occupational, social, and emotional functioning. Developing optimal treatment approaches for this population is key in improving their functioning.

Clinical Details

Official title: Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline

Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)

Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)

Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)

Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)

Secondary outcome:

Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline

Depression symptoms (via the Beck Depression Inventory) - Change from baseline

Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline

Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline

Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline

Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline

Self-esteem (measured via the Index of Self-Esteem) - Change from baseline

Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline

Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision

(DSM-IV-TR) criteria for adult ADHD of any of three subtypes via Conners' Adult ADHD Diagnostic Interview for the DSM-IV (CAAR-D) and clinician's assessment;

- 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:

- Psychotic symptoms, past or current

- 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.

Locations and Contacts

Tara Errington, MSc, Phone: 514-412-4400, Ext: 23286, Email: adhd.research.adult@gmail.com

Montreal Children's Hospital, Montreal, Quebec H3Z 1P2, Canada; Recruiting
Tara Errington, MSc, Phone: 514-412-4400, Ext: 23286, Email: adhd.research.adult@gmail.com
Lily Hechtman, MD, FRCP, Principal Investigator
Additional Information

Related publications:

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.

Safren SA. Cognitive-behavioral approaches to ADHD treatment in adulthood. J Clin Psychiatry. 2006;67 Suppl 8:46-50. Review.

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. Review.

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.

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. Review.

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.

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.

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

Starting date: April 2006
Last updated: July 8, 2015

Page last updated: August 23, 2015

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