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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

methylphenidate or amphetamine product

Cognitive behavioral therapy

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring cognitive behavioral therapy, stimulant medication, efficacy, symptoms, functional outcomes

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Medication only

Cognitive behavioral therapy + medication

Cognitive behavioral therapy alone

Arm 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.

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

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Global psychological distress (measured via the Symptom Checklist 90) - Change from baseline

Depression symptoms (via the Beck Depression Inventory) - Change from baseline

Anxiety symptoms (measured via the Beck Anxiety Inventory) - Change from baseline

Global functional impairment (measured via the Sheehan Disability Scale) - Change from baseline

Dyadic adjustment (for those married or cohabiting, measured via the Dyadic Adjustment Scale) - Change from baseline

Organizational skills (measured via the Organization and Activation for Work Scale) - Change from baseline

Self-esteem (measured via the Index of Self-Esteem) - Change from baseline

Anger Expression (measured via the State Trait Anger Expression Inventory - II) - Change from baseline

Observer-Rated ADHD symptoms (measured via the Barkley's Current ADHD Symptoms Scale -- observer version) - Change from baseline

Full Information

NCT ID

NCT02210728

First Posted

July 31, 2014

Last Updated

August 27, 2018

Sponsor

Lily Hechtman

1. Study Identification

Unique Protocol Identification Number

NCT02210728

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 2006 (undefined)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lily Hechtman

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medication only

Arm Type

Active Comparator

Arm 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 Title

Cognitive behavioral therapy + medication

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cognitive behavioral therapy alone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

methylphenidate or amphetamine product

Other Intervention Name(s)

Ritalin, Concerta, Biphentin, Dexedrine, Adderall XR, Vyvanse

Intervention 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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive behavioral therapy

Intervention 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.

Primary Outcome Measure Information:

Title

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

Time Frame

At baseline

Title

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.

Title

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

Time Frame

After 12 weeks of Cognitive Behavioural Therapy

Title

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

Time Frame

Three months after the end of Cognitive Behavioural Therapy

Title

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 Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lily Hechtman, MD, FRCPC

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montreal Children's Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3Z 1P2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

16585449

Citation

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Results Reference

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PubMed Identifier

16961430

Citation

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

Results Reference

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PubMed Identifier

11967475

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.

Results Reference

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Citation

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Citation

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Citation

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Citation

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Results Reference

result

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

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