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

Not Applicable

Completed

• Conditions: Attention Deficit Disorder
• Interventions: Behavioral: CBT with booster sessions; Behavioral: CBT only

• Registration Number: NCT02062411
• Lead Sponsor: Peking University Sixth Hospital

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT with booster sessions	CBT with booster sessions	Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol.
CBT only	CBT only	Participants will only receive 12 cognitive-behavioral therapy sessions weekly.

Primary Outcome Measures

Name	Time	Method
Change in ADHD Rating Scale	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)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Conners Adult ADHD Rating Scale Self-report Screening Version (CAARS-S:SV)	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)	The CAARS-S:SV is a self-reported scale measures the ADHD symptom severity including 30 items rating from 0 to 3.
Change in Self-rating depression scale (SDS)	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)	The Self-rating depression scale (SDS) is used to measure the level of depression.
Change in self-esteem scale (SES)	Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)	The self-esteem scale measures the level of self-esteem.
Change in World Health Organization Quality of Life-Brief Version (WHOQOL-BREF)	Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)	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.
Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)	Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)	The CANTAB is a computerized neuropsychological test measuring the cognitive and executive function.
Change in Barratt impulsiveness scale (BIS)	Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)	The Barratt impulsiveness scale including 30 items is used to measure impulsiveness.
Change in Brain Oxygenation Level Dependent (BOLD) Signal	Baseline, 12 weeks (post)	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.
Change in Self-Rating Anxiety Scale (SAS)	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)	The Self-Rating Anxiety Scale (SAS) with 20 items measures the level of anxiety.
Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)	Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)	The BRIEF-A measures the impairment level of executive function in ADHD adults.

Trial Locations

Locations (1)

Peking University Sixth Hospital; 🇨🇳 Beijing, Beijing, China