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Completed

NCT Number: NCT02062411

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

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).

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Key information

Conditions

Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT only

Behavioral

Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.

Other names: Mastering Your Adult ADHD manual (Safren, et al., 2005)

CBT with booster sessions

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 13, 2014
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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