A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
April 28, 2016 updated by: Qiujin Qian, Peking University Sixth Hospital
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100191
- Peking University Sixth Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CBT with booster sessions
Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol.
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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.
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Active Comparator: CBT only
Participants will only receive 12 cognitive-behavioral therapy sessions weekly.
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Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.
Other Names:
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No Intervention: waiting
Participations will not be treated with CBT and keep waiting for 12 weeks for comparison.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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)
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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.
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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)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Conners Adult ADHD Rating Scale Self-report Screening Version (CAARS-S:SV)
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)
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The CAARS-S:SV is a self-reported scale measures the ADHD symptom severity including 30 items rating from 0 to 3.
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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)
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Change in Self-Rating Anxiety Scale (SAS)
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)
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The Self-Rating Anxiety Scale (SAS) with 20 items measures the level of anxiety.
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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)
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Change in Self-rating depression scale (SDS)
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)
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The Self-rating depression scale (SDS) is used to measure the level of depression.
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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)
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Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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The BRIEF-A measures the impairment level of executive function in ADHD adults.
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Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)
Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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The CANTAB is a computerized neuropsychological test measuring the cognitive and executive function.
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Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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Change in Barratt impulsiveness scale (BIS)
Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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The Barratt impulsiveness scale including 30 items is used to measure impulsiveness.
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Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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Change in self-esteem scale (SES)
Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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The self-esteem scale measures the level of self-esteem.
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Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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Change in World Health Organization Quality of Life-Brief Version (WHOQOL-BREF)
Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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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.
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Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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Change in Brain Oxygenation Level Dependent (BOLD) Signal
Time Frame: Baseline, 12 weeks (post)
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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.
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Baseline, 12 weeks (post)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Qiujin Qian, PhD, Peking University Sixth Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
February 12, 2014
First Submitted That Met QC Criteria
February 12, 2014
First Posted (Estimate)
February 13, 2014
Study Record Updates
Last Update Posted (Estimate)
April 29, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-9-23-3
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