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Trial record 65 of 79 for:    AMPHETAMINE AND DEXTROAMPHETAMINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date  ICMJE July 31, 2014
First Posted Date  ICMJE August 7, 2014
Last Update Posted Date August 28, 2018
Study Start Date  ICMJE April 2006
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
  • Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) - Change from baseline [ Time Frame: At baseline ]
  • 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. ]
  • Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: After 12 weeks of Cognitive Behavioural Therapy ]
  • Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: Three months after the end of Cognitive Behavioural Therapy ]
  • Self-reported ADHD symptoms (measured via Barkley's Current ADHD Symptoms Scale) [ Time Frame: Six months after the end of Cognitive Behavioural Therapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2014)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder
Official Title  ICMJE Efficacy of Cognitive Behavioral Therapy in Treatment of Adults With Attention Deficit Hyperactivity Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: methylphenidate or amphetamine product
  • 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.
    Interventions:
    • Drug: methylphenidate or amphetamine product
    • Behavioral: Cognitive behavioral 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.
    Intervention: Behavioral: Cognitive behavioral therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02210728
Other Study ID Numbers  ICMJE PED-06-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lily Hechtman, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE Lily Hechtman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lily Hechtman, MD, FRCPC McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP