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

Primary Purpose

Attention Deficit Disorder

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CBT only

CBT with booster sessions

About this trial

This is an interventional treatment trial for Attention Deficit Disorder focused on measuring attention deficit disorder (ADHD), cognitive behavioral therapy (CBT), adult

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking University Sixth Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

CBT with booster sessions

CBT only

waiting

Arm Description

Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol.

Participants will only receive 12 cognitive-behavioral therapy sessions weekly.

Participations will not be treated with CBT and keep waiting for 12 weeks for comparison.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Change in Self-Rating Anxiety Scale (SAS)

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

Change in Self-rating depression scale (SDS)

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

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.

Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)

The CANTAB is a computerized neuropsychological test measuring the cognitive and executive function.

Change in Barratt impulsiveness scale (BIS)

The Barratt impulsiveness scale including 30 items is used to measure impulsiveness.

Change in self-esteem scale (SES)

The self-esteem scale measures the level of self-esteem.

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.

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.

Full Information

NCT ID

NCT02062411

First Posted

February 12, 2014

Last Updated

April 28, 2016

Sponsor

Peking University Sixth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02062411

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Sixth Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Disorder

Keywords

attention deficit disorder (ADHD), cognitive behavioral therapy (CBT), adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT with booster sessions

Arm Type

Experimental

Arm Description

Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol.

Arm Title

CBT only

Arm Type

Active Comparator

Arm Description

Participants will only receive 12 cognitive-behavioral therapy sessions weekly.

Arm Title

waiting

Arm Type

No Intervention

Arm Description

Participations will not be treated with CBT and keep waiting for 12 weeks for comparison.

Intervention Type

Behavioral

Intervention Name(s)

CBT only

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

CBT with booster sessions

Intervention Description

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 Outcome Measure Information:

Title

Change in ADHD Rating Scale

Description

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.

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)

Secondary Outcome Measure Information:

Title

Change in Conners Adult ADHD Rating Scale Self-report Screening Version (CAARS-S:SV)

Description

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

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)

Title

Change in Self-Rating Anxiety Scale (SAS)

Description

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

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)

Title

Change in Self-rating depression scale (SDS)

Description

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

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)

Title

Change in Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A)

Description

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

Time Frame