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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02210728
• Other study ID #: PED-06-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2006
• Est. completion date: October 2018

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Drug:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Montreal Children's Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Lily Hechtman

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Barkley, R. A., Murphy, K. R., & Firscher, M. (2008). ADHD in adults: What the Science Says. New York: Guilford Press

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. — View Citation

Gualtieri CT, Ondrusek MG, Finley C. Attention deficit disorders in adults. Clin Neuropharmacol. 1985;8(4):343-56. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Weiss, G., & Hechtman, L. (1993). Hyperactive children grown up : ADHD in children, adolescents, and adults (2nd ed.). New York: Guilford Press.

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline		At baseline
Primary	Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)		For patients in a medication or combined group - after medication has been optimally titrated, approximately 5 weeks.
Primary	Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)		After 12 weeks of Cognitive Behavioural Therapy
Primary	Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)		Three months after the end of Cognitive Behavioural Therapy
Primary	Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)		Six months after the end of Cognitive Behavioural Therapy
Secondary	Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Depression symptoms (via the Beck Depression Inventory) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline		At baseline; once optimally titrated, approximately 5 weeks (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Self-esteem (measured via the Index of Self-Esteem) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up
Secondary	Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline		At baseline; once optimally titrated, takes approximately 5 weeks to reach this dose (for medicated participants); after cognitive behavioural therapy; 3 months of follow up; 6 months of follow up