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

Attention Deficit Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062411
• Other study ID #: 2013-9-23-3
• Status: Completed
• Phase: N/A
• First received: February 12, 2014
• Last updated: April 28, 2016
• Start date: October 2013
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Peking University Sixth Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• CBT only
Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.
• CBT with booster sessions
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.

Locations

Country	Name	City	State
China	Peking University Sixth Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No