Attention Deficit DisorderNCT02062411
A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
A study testing CBT only and CBT with booster sessions in people with Attention Deficit Disorder, run by Peking University Sixth Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- CBT only and CBT with booster sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
About this study
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).
Read the 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.
- Conditions
- Attention Deficit Disorder
- Being tested
- CBT only, CBT with booster sessions
- Keywords
- attention deficit disorder (ADHD), cognitive behavioral therapy (CBT), adult
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT onlyBehavioural
Also called Mastering Your Adult ADHD manual (Safren, et al., 2005)
Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.
CBT with booster sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT with booster sessions | Experimental | Participants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol. Receives: Behavioral: CBT with booster sessions |
| CBT only | Active comparator | Participants will only receive 12 cognitive-behavioral therapy sessions weekly. Receives: Behavioral: CBT only |
| waiting | No intervention | Participations will not be treated with CBT and keep waiting for 12 weeks for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (9)
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.
Measured: 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 Anxiety Scale (SAS)
The Self-Rating Anxiety Scale (SAS) with 20 items measures the level of anxiety.
Measured: 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)
The Self-rating depression scale (SDS) is used to measure the level of depression.
Measured: 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)
The BRIEF-A measures the impairment level of executive function in ADHD adults.
Measured: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)
The CANTAB is a computerized neuropsychological test measuring the cognitive and executive function.
Measured: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
Change in Barratt impulsiveness scale (BIS)
The Barratt impulsiveness scale including 30 items is used to measure impulsiveness.
Measured: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
Change in self-esteem scale (SES)
The self-esteem scale measures the level of self-esteem.
Measured: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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.
Measured: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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.
Measured: Baseline, 12 weeks (post)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiujin Qian, Peking University Sixth Hospital
- Investigators
- Qiujin Qian, PhD, Study director, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062411
- Sponsor's protocol ID
- 2013-9-23-3
- Status last verified
- Apr 2016
- First submitted
- 12 Feb 2014
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Huang F, Qian Q, Wang Y. Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Apr 14;16:161. doi: 10.1186/s13063-015-0686-1.
PubMed 25873090
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Cognitive Behavioral Therapy for Adults With Attention Deficit Disorder
- ClinicalTrials.gov ID
- NCT02062411
- Acronym / sponsor ID
- 2013-9-23-3
- Conditions
- Attention Deficit Disorder
- Keywords
- attention deficit disorder (ADHD), cognitive behavioral therapy (CBT), adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT with booster sessions | Experimental | Behavioral: CBT with booster sessionsParticipants will receive 12 cognitive-behavioral therapy sessions weekly and 3 booster sessions monthly following our protocol. |
| CBT only | Active comparator | Behavioral: CBT onlyParticipants will only receive 12 cognitive-behavioral therapy sessions weekly. |
| waiting | No intervention | –Participations will not be treated with CBT and keep waiting for 12 weeks for comparison. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT onlyAlso: Mastering Your Adult ADHD manual (Safren, et al., 2005)Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking. | Behavioural | CBT only |
| CBT with booster sessionsParticipants 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. | Behavioural | CBT with booster sessions |
Primary outcome
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.
9 secondary outcomes
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)
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)
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)
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)
Change in Cambridge Neuropsychological Test Automatic Battery (CANTAB)
Time frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
Change in Barratt impulsiveness scale (BIS)
Time frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
Change in self-esteem scale (SES)
Time frame: Baseline, 12 weeks (post), 24 weeks (FU6), and 48 weeks (FU12)
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)
Change in Brain Oxygenation Level Dependent (BOLD) Signal
Time frame: Baseline, 12 weeks (post)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Derived from this study: PubMed 25873090Huang F, Qian Q, Wang Y. Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial. Trials. 2015 Apr 14;16:161. doi: 10.1186/s13063-015-0686-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiujin Qian, PhD study director
Peking University Sixth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT only and CBT with booster sessions in people with Attention Deficit Disorder, run by Peking University Sixth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.