A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder

Study Overview
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Brief Summary
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The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective in the treatment of attention deficit and emotional, executive function and social function dysregulation due to attention deficit disorder (ADHD).

Detailed Description
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Participations will be randomly assigned to 3 groups which are CBT with booster sessions group, CBT only group and waiting group.With the comparison of first tow groups we will explore the effect of booster sessions, and the last two groups the effect of CBT programme.

Official Title
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A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder

Conditions
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Attention Deficit Disorder

Intervention / Treatment
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* Behavioral: CBT only
* Behavioral: CBT with booster sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients from Peking University Sixth Hospital Diagnosis of adult ADHD based on Diagnostic and statistical manual of mental disorders, Fourth Edition (DSM-IV) Stable on medications for adult ADHD for at least 2 months Exclusion Criteria: Severe major depression, clinically significant panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders Intelligence Quotient (IQ) less than 90 Suicide risk Unstable physical condition Prior participation in cognitive behavioral therapy for ADHD or other psychological therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT with booster sessions<br>Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol. | Behavioral: CBT with booster sessions<br>* Participants are provided with the same CBT programme and additional 3 booster sessions which summarize and extend the 3 main topics of the CBT programme in order to improve the skills practice ability.<br>|
| Active Comparator: CBT only<br>Participants will only receive 12 cognitive-behavioral therapy sessions weekly. | Behavioral: CBT only<br>* Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.<br>* Other names: Mastering Your Adult ADHD manual (Safren, et al., 2005);|
| No Intervention: waiting<br>Participations will not be treated with CBT and keep waiting for 12 weeks for comparison. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADHD Rating Scale | ADHD symptom severity as measured by the ADHD rating scale (DuPaul, et al., 1998) a scale that ranges from 0-54 with 0 indicating lower severity. | Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Conners Adult ADHD Rating Scale Self-report Screening Version (CAARS-S:SV) | The CAARS-S:SV is a self-reported scale measures the ADHD symptom severity including 30 items rating from 0 to 3. | Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12) | 
| Change in Self-Rating Anxiety Scale (SAS) | The Self-Rating Anxiety Scale (SAS) with 20 items measures the level of anxiety. | Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12) | 
| Change in Self-rating depression scale (SDS) | The Self-rating depression scale (SDS) is used to measure the level of depression. | Baseline, at the end of week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, and 11 in treatment, 12 weeks (post), 24 weeks (FU6), 36 weeks (FU9), and 48 weeks (FU12) | 
| Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) | The BRIEF-A measures the impairment level of executive function in ADHD adults. | Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) | 
| Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB) | The CANTAB is a computerized neuropsychological test measuring the cognitive and executive function. | Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) | 
| Change in Barratt impulsiveness scale (BIS) | The Barratt impulsiveness scale including 30 items is used to measure impulsiveness. | Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) | 
| Change in self-esteem scale (SES) | The self-esteem scale measures the level of self-esteem. | Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) | 
| Change in World Health Organization Quality of Life-Brief Version (WHOQOL-BREF) | The WHOQOL-BREF is the short version of World Health Organization Quality of Life scale and includes 26 items measuring the level of life quality. | Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) | 
| Change in Brain Oxygenation Level Dependent (BOLD) Signal | The level of BOLD activity during working memory task after CBT is compared with baseline level to explore the potential effects of CBT on brain. | Baseline, 12 weeks (post) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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attention deficit disorder (ADHD), cognitive behavioral therapy (CBT), adult