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

N/ACompletedNCT02062411

Peking University Sixth Hospital108 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

108

Conditions

Attention Deficit Disorder

Interventions

CBT onlyBEHAVIORAL

Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.

CBT with booster sessionsBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)

Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)

Data from ClinicalTrials.gov

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