<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02210728</url>
  </required_header>
  <id_info>
    <org_study_id>PED-06-002</org_study_id>
    <nct_id>NCT02210728</nct_id>
  </id_info>
  <brief_title>Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder</brief_title>
  <official_title>Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lily Hechtman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (CBT)&#xD;
      for adults with attention deficit hyperactivity disorder (ADHD) with and without stimulant&#xD;
      medication and compare it to medication alone. Subjects will be randomly assigned to&#xD;
      stimulant medication only, CBT only and combined CBT and stimulant medication group. Patients&#xD;
      will be evaluated at baseline, following mediation optimization (for medicated groups),&#xD;
      following 12 months of treatment, after 3 months of follow up, and after 6 months of follow&#xD;
      up. The investigators hypothesize that the combined group will have the best outcome at all&#xD;
      evaluation points. ADHD in adults is associated with significant morbidity and impaired&#xD;
      academic, occupational, social, and emotional functioning. Developing optimal treatment&#xD;
      approaches for this population is key in improving their functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2006</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)</measure>
    <time_frame>For patients in a medication or combined group - after medication has been optimally titrated, approximately 5 weeks.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)</measure>
    <time_frame>After 12 weeks of Cognitive Behavioural Therapy</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)</measure>
    <time_frame>Three months after the end of Cognitive Behavioural Therapy</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)</measure>
    <time_frame>Six months after the end of Cognitive Behavioural Therapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression symptoms (via the Beck Depression Inventory) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-esteem (measured via the Index of Self-Esteem) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline</measure>
    <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</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>Medication only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive behavioral therapy + medication</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients are first titrated to an optimal dose of stimulant medication. They then undergo the 12 weeks of group cognitive behavioral therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive behavioral therapy alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methylphenidate or amphetamine product</intervention_name>
    <description>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.</description>
    <arm_group_label>Cognitive behavioral therapy + medication</arm_group_label>
    <arm_group_label>Medication only</arm_group_label>
    <other_name>Ritalin</other_name>
    <other_name>Concerta</other_name>
    <other_name>Biphentin</other_name>
    <other_name>Dexedrine</other_name>
    <other_name>Adderall XR</other_name>
    <other_name>Vyvanse</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavioral therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>Cognitive behavioral therapy + medication</arm_group_label>
    <arm_group_label>Cognitive behavioral therapy alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision&#xD;
             (DSM-IV-TR) criteria for adult ADHD of any of three subtypes via Conners' Adult ADHD&#xD;
             Diagnostic Interview for the DSM-IV (CAAR-D) and clinician's assessment;&#xD;
&#xD;
          -  Barkley Childhood and Current Symptom of ADHD (1998) completed by self and informants&#xD;
             (parents or siblings). Required cut off's on these scales are scores 1.5 Standard&#xD;
             Deviation above relevant gender and age norms;&#xD;
&#xD;
          -  Conners' Adult ADHD Rating Scale (1999). Required cut off's on these scales are scores&#xD;
             1.5 Standard Deviation above relevant gender and age norms;&#xD;
&#xD;
          -  Between 18 and 60 years old&#xD;
&#xD;
          -  Be able to give informed consent and comply with study procedures;&#xD;
&#xD;
          -  I.Q. of 80 or above on Wechsler Adult Intelligence Scale, 3rd edition (WAIS-III)&#xD;
             subtests of three verbal and three nonverbal subtests&#xD;
&#xD;
          -  Adequate command of English to be able to participate in CBT group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotic symptoms, past or current&#xD;
&#xD;
          -  Current psychiatric comorbidity, e.g. bipolar disorder, depression, suicidality,&#xD;
             current substance use disorder (must be free of substance abuse for 6 months)&#xD;
&#xD;
          -  Medical condition that preclude use of the stimulant medication, e.g. hypertension,&#xD;
             cardiac disease, Tourette's Syndrome, etc.&#xD;
&#xD;
          -  Organic mental disorders or other significant neurological disorders, e.g. epilepsy,&#xD;
             head injury, chorea, multiple sclerosis, deafness, blindness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lily Hechtman, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montreal Children's Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3Z 1P2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>16585449</PMID>
  </reference>
  <reference>
    <citation>Safren SA. Cognitive-behavioral approaches to ADHD treatment in adulthood. J Clin Psychiatry. 2006;67 Suppl 8:46-50.</citation>
    <PMID>16961430</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11967475</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18310557</PMID>
  </reference>
  <reference>
    <citation>Gualtieri CT, Ondrusek MG, Finley C. Attention deficit disorders in adults. Clin Neuropharmacol. 1985;8(4):343-56. doi: 10.1097/00002826-198512000-00005.</citation>
    <PMID>4075304</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18928346</PMID>
  </reference>
  <reference>
    <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. doi: 10.1001/archpsyc.1983.01790220049008.</citation>
    <PMID>6388523</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20736471</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20231319</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/j.biopsych.2004.11.043.</citation>
    <PMID>15737659</PMID>
  </reference>
  <reference>
    <citation>Weiss, G., &amp; Hechtman, L. (1993). Hyperactive children grown up : ADHD in children, adolescents, and adults (2nd ed.). New York: Guilford Press.</citation>
  </reference>
  <reference>
    <citation>Barkley, R. A., Murphy, K. R., &amp; Firscher, M. (2008). ADHD in adults: What the Science Says. New York: Guilford Press</citation>
  </reference>
  <results_reference>
    <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.</citation>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Lily Hechtman</investigator_full_name>
    <investigator_title>Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry</investigator_title>
  </responsible_party>
  <keyword>cognitive behavioral therapy</keyword>
  <keyword>stimulant medication</keyword>
  <keyword>efficacy</keyword>
  <keyword>symptoms</keyword>
  <keyword>functional outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylphenidate</mesh_term>
    <mesh_term>Amphetamine</mesh_term>
    <mesh_term>Adderall</mesh_term>
    <mesh_term>Dextroamphetamine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02210728
org study id: PED-06-002
nct id: NCT02210728
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline
time frame: At baseline
measure: 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.
measure: Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
time frame: After 12 weeks of Cognitive Behavioural Therapy
measure: Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
time frame: Three months after the end of Cognitive Behavioural Therapy
measure: Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale)
time frame: Six months after the end of Cognitive Behavioural Therapy
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
arm group label: Medication only
arm group type: Active Comparator
description: 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.
arm group label: Cognitive behavioral therapy + medication
arm group type: Active Comparator
description: Patients are first titrated to an optimal dose of stimulant medication. They then undergo the 12 weeks of group cognitive behavioral therapy.
arm group label: Cognitive behavioral therapy alone
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: methylphenidate or amphetamine product
description: 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.
arm group label: Cognitive behavioral therapy + medication
arm group label: Medication only
other name: Ritalin
other name: Concerta
other name: Biphentin
other name: Dexedrine
other name: Adderall XR
other name: Vyvanse
intervention type: Behavioral
intervention name: Cognitive behavioral therapy
description: 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.
arm group label: Cognitive behavioral therapy + medication
arm group label: Cognitive behavioral therapy alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Lily Hechtman, MD, FRCPC
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
facility: 
country: Canada
citation: 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
citation: Safren SA. Cognitive-behavioral approaches to ADHD treatment in adulthood. J Clin Psychiatry. 2006;67 Suppl 8:46-50.
PMID: 16961430
citation: 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
citation: 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
citation: 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
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.
PMID: 18928346
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. doi: 10.1001/archpsyc.1983.01790220049008.
PMID: 6388523
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.
PMID: 20736471
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.
PMID: 20231319
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. doi: 10.1016/j.biopsych.2004.11.043.
PMID: 15737659
citation: Weiss, G., & Hechtman, L. (1993). Hyperactive children grown up : ADHD in children, adolescents, and adults (2nd ed.). New York: Guilford Press.
citation: Barkley, R. A., Murphy, K. R., & Firscher, M. (2008). ADHD in adults: What the Science Says. New York: Guilford Press
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.
responsible party type: Sponsor-Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Lily Hechtman
investigator title: Professor of Psychiatry and Pediatrics; Director of Research - Division of Child Psychiatry
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity
mesh term: Methylphenidate
mesh term: Amphetamine
mesh term: Adderall
mesh term: Dextroamphetamine