Attention Deficit Disorder With HyperactivityPhase 1NCT00050050
Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder
A Phase 1 study testing Cognitive behavioral therapy and Drug therapy in people with Attention Deficit Disorder With Hyperactivity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment. Study hypothesis: CBT is an effective treatment for adult ADHD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Cognitive behavioral therapy and Drug therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2003
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ADHD of at least moderate severity
- On current drug therapy for ADHD
Who cannot join
- Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
- Current substance abuse or dependence
- IQ less than 90
- Suicide risk
- History of cognitive behavioral therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: CBT for Residual ADHD Symptoms in Adults
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment.
Study hypothesis: CBT is an effective treatment for adult ADHD.
Read the detailed description
ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies.
Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion.
- Being tested
- Cognitive behavioral therapy, Drug therapy
- Keywords
- Adult, ADHD, ADD
- 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.
Cognitive behavioral therapyBehavioural
Drug therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2002 (estimated)
- Study startSep 2001
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Steven A. Safren, Massachusetts General Hospital
- Investigators
- Steven A. Safren, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050050
- Sponsor's protocol ID
- R03MH060940
- Other IDs
- R03MH060940, DSIR AT-AS
- Status last verified
- May 2014
- First submitted
- 20 Nov 2002
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Residual ADHD Symptoms in Adults
- ClinicalTrials.gov ID
- NCT00050050
- Acronym / sponsor ID
- R03MH060940
- Keywords
- Adult, ADHD, ADD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 21 Nov 2002 (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.
This study will determine the effectiveness of cognitive behavioral therapy (CBT) in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in adults who have not responded to drug treatment.
Study hypothesis: CBT is an effective treatment for adult ADHD.
Detailed description
ADHD, previously believed to be a disorder of childhood, affects as many as 5 percent of adults. Adults with ADHD are at high risk for academic and occupational underachievement, relationship difficulties, and reduced quality of life. This study will determine whether CBT is more effective than drug therapy in treating ADHD symptoms in adults who have been resistant to previous drug therapies.
Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or drug therapy which may include new or previously taken drugs. Questionnaires will be used to assess participants' ADHD symptoms at study start and at study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult ADHD of at least moderate severity
- On current drug therapy for ADHD
Key exclusion criteria (5 listed)
- Depression, panic disorder, bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
- Current substance abuse or dependence
- IQ less than 90
- Suicide risk
- History of cognitive behavioral 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 |
|---|---|---|
| Cognitive behavioral therapy | Behavioural | – |
| Drug therapy | Drug | – |
Primary outcome
ADHD symptoms
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 26 May 2014.
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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.
Steven A. Safren, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive behavioral therapy and Drug therapy in people with Attention Deficit Disorder With Hyperactivity, run by Massachusetts General Hospital at 1 site in United States.
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 2 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 26 May 2014. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ADHD symptoms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2014.