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

Lily Hechtman

Status: Unknown

Conditions: Attention Deficit Hyperactivity Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02210728

PED-06-002

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Medication only

Active Comparator group

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.

Treatment:

Drug: methylphenidate or amphetamine product

Cognitive behavioral therapy + medication

Active Comparator group

Description:

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

Treatment:

Drug: methylphenidate or amphetamine product

Behavioral: Cognitive behavioral therapy

Cognitive behavioral therapy alone

Experimental group

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.

Treatment:

Behavioral: Cognitive behavioral therapy