Clinical trial NCT02062411: A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
Official title: A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder
Keywords: attention deficit disorder (ADHD)
cognitive behavioral therapy (CBT)
adult
Lead sponsor: Peking University Sixth Hospital
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ADHD Rating Scale
timeFrame: 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:
measure: Change in Conners Adult ADHD Rating Scale Self-report Screening Version (CAARS-S:SV)
timeFrame: 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)
measure: Change in Self-Rating Anxiety Scale (SAS)
timeFrame: 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)
measure: Change in Self-rating depression scale (SDS)
timeFrame: 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)
measure: Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
timeFrame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
measure: Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)
timeFrame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
measure: Change in Barratt impulsiveness scale (BIS)
timeFrame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
measure: Change in self-esteem scale (SES)
timeFrame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
measure: Change in World Health Organization Quality of Life-Brief Version (WHOQOL-BREF)
timeFrame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
measure: Change in Brain Oxygenation Level Dependent (BOLD) Signal
timeFrame: Baseline, 12 weeks (post)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital
state: Beijing
Study officials:
affiliation: Peking University Sixth Hospital
name: Qiujin Qian, PhD
role: STUDY_DIRECTOR
References:
citation: Huang F, Qian Q, Wang Y. Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Apr 14;16:161. doi: 10.1186/s13063-015-0686-1.