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

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ClinicalTrials.gov Identifier: NCT02210728
Recruitment Status : Active, not recruiting
First Posted : August 7, 2014
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Lily Hechtman, McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: methylphenidate or amphetamine product Behavioral: Cognitive behavioral therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder
Study Start Date : April 2006
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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.
Other Names:
  • Ritalin
  • Concerta
  • Biphentin
  • Dexedrine
  • Adderall XR
  • Vyvanse

Active Comparator: 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.
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.
Other Names:
  • Ritalin
  • Concerta
  • Biphentin
  • Dexedrine
  • Adderall XR
  • Vyvanse

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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline [ Time Frame: At baseline ]
  2. Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: For patients in a medication or combined group - after medication has been optimally titrated, approximately 5 weeks. ]
  3. Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: After 12 weeks of Cognitive Behavioural Therapy ]
  4. Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: Three months after the end of Cognitive Behavioural Therapy ]
  5. Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: Six months after the end of Cognitive Behavioural Therapy ]

Secondary Outcome Measures :
  1. Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline [ Time Frame: 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 ]
  2. Depression symptoms (via the Beck Depression Inventory) - Change from baseline [ Time Frame: 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 ]
  3. Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline [ Time Frame: 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 ]
  4. Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline [ Time Frame: 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 ]
  5. Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline [ Time Frame: 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 ]
  6. Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline [ Time Frame: 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 ]
  7. Self-esteem (measured via the Index of Self-Esteem) - Change from baseline [ Time Frame: 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 ]
  8. Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline [ Time Frame: 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 ]
  9. Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline [ Time Frame: 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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210728


Locations
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Canada, Quebec
Montreal Children's Hospital
Montreal, Quebec, Canada, H3Z 1P2
Sponsors and Collaborators
Lily Hechtman
Investigators
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Principal Investigator: Lily Hechtman, MD, FRCPC McGill University Health Center

Publications of Results:
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 Publications:
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

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Responsible Party: Lily Hechtman, Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry, McGill University Health Center
ClinicalTrials.gov Identifier: NCT02210728     History of Changes
Other Study ID Numbers: PED-06-002
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Lily Hechtman, McGill University Health Center:
cognitive behavioral therapy
stimulant medication
efficacy
symptoms
functional outcomes

Additional relevant MeSH terms:
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Amphetamine
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors