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Clinical Trials/NCT02062411
NCT02062411
Completed
N/A

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

Peking University Sixth Hospital1 site in 1 country108 target enrollmentOctober 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Disorder
Sponsor
Peking University Sixth Hospital
Enrollment
108
Locations
1
Primary Endpoint
Change in ADHD Rating Scale
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University Sixth Hospital
Responsible Party
Principal Investigator
Principal Investigator

Qiujin Qian

PhD

Peking University Sixth Hospital

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

Outcomes

Primary Outcomes

Change in ADHD Rating Scale

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)

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 Outcomes

  • 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))
  • 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))
  • Change in self-esteem scale (SES)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
  • Change in World Health Organization Quality of Life-Brief Version (WHOQOL-BREF)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
  • Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
  • Change in Barratt impulsiveness scale (BIS)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))
  • Change in Brain Oxygenation Level Dependent (BOLD) Signal(Baseline, 12 weeks (post))
  • 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))
  • Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)(Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12))

Study Sites (1)

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