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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02062411
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : April 29, 2016
Sponsor:
Information provided by (Responsible Party):
Qiujin Qian, 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).

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder Behavioral: CBT only Behavioral: CBT with booster sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
Study Start Date : October 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT with booster sessions
Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol.
Behavioral: 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.

Active Comparator: CBT only
Participants will only receive 12 cognitive-behavioral therapy sessions weekly.
Behavioral: CBT only
Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.
Other Name: Mastering Your Adult ADHD manual (Safren, et al., 2005)

No Intervention: waiting
Participations will not be treated with CBT and keep waiting for 12 weeks for comparison.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) ]
    The CAARS-S:SV is a self-reported scale measures the ADHD symptom severity including 30 items rating from 0 to 3.

  2. 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) ]
    The Self-Rating Anxiety Scale (SAS) with 20 items measures the level of anxiety.

  3. 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) ]
    The Self-rating depression scale (SDS) is used to measure the level of depression.

  4. 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) ]
    The BRIEF-A measures the impairment level of executive function in ADHD adults.

  5. Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB) [ Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) ]
    The CANTAB is a computerized neuropsychological test measuring the cognitive and executive function.

  6. Change in Barratt impulsiveness scale (BIS) [ Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) ]
    The Barratt impulsiveness scale including 30 items is used to measure impulsiveness.

  7. Change in self-esteem scale (SES) [ Time Frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12) ]
    The self-esteem scale measures the level of self-esteem.

  8. 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) ]
    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.

  9. Change in Brain Oxygenation Level Dependent (BOLD) Signal [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062411


Locations
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China, Beijing
Peking University Sixth Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Peking University Sixth Hospital
Investigators
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Study Director: Qiujin Qian, PhD Peking University Sixth Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qiujin Qian, PhD, Peking University Sixth Hospital
ClinicalTrials.gov Identifier: NCT02062411    
Other Study ID Numbers: 2013-9-23-3
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016
Keywords provided by Qiujin Qian, Peking University Sixth Hospital:
attention deficit disorder (ADHD)
cognitive behavioral therapy (CBT)
adult
Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders