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

NCT02210728 | Unknown

• 1 other identifier: PED-06-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

cognitive behavioral therapy; stimulant medication; efficacy; symptoms; functional outcomes

Outcome Measures

Primary Outcomes (5)

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

  At baseline

• 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.

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

  After 12 weeks of Cognitive Behavioural Therapy

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

  Three months after the end of Cognitive Behavioural Therapy

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

  Six months after the end of Cognitive Behavioural Therapy

Secondary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Medication only

ACTIVE COMPARATOR

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.

Drug: methylphenidate or amphetamine product

Cognitive behavioral therapy + medication

ACTIVE COMPARATOR

Patients are first titrated to an optimal dose of stimulant medication. They then undergo the 12 weeks of group cognitive behavioral therapy.

Drug: methylphenidate or amphetamine product; Behavioral: Cognitive behavioral therapy

Cognitive behavioral therapy alone

EXPERIMENTAL

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.

Behavioral: Cognitive behavioral therapy

Interventions

methylphenidate or amphetamine product DRUG

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.

Also known as: Ritalin, Concerta, Biphentin, Dexedrine, Adderall XR, Vyvanse

Cognitive behavioral therapy + medication; Medication only

Cognitive behavioral therapy BEHAVIORAL

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 + medication; Cognitive behavioral therapy alone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lily Hechtman: lead

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3Z 1P2, Canada

Location

Related Publications (13)

• 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.

  PMID: 16585449 BACKGROUND

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

  PMID: 16961430 BACKGROUND

• 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.

  PMID: 11967475 BACKGROUND

• 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.

  PMID: 18310557 BACKGROUND

• Gualtieri CT, Ondrusek MG, Finley C. Attention deficit disorders in adults. Clin Neuropharmacol. 1985;8(4):343-56. doi: 10.1097/00002826-198512000-00005.

  PMID: 4075304 BACKGROUND

• 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.

  PMID: 18928346 BACKGROUND

• 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.

  PMID: 6388523 BACKGROUND

• 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.

  PMID: 20736471 BACKGROUND

• 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.

  PMID: 20231319 BACKGROUND

• 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.

  PMID: 15737659 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• 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.

  RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Dextroamphetamine; SLI381; Lisdexamfetamine Dimesylate; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lily Hechtman, MD, FRCPC

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 7, 2014
• Study Start: April 1, 2006
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

CA (1)