Attention Deficit Disorder With HyperactivityNCT00118911
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
A study testing Cognitive behavioral therapy (CBT) and Relaxation techniques and education about ADHD 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 efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder. 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 (CBT) and Relaxation techniques and education about ADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of adult ADHD of at least mild clinical severity (CGI score of 3 or greater)
- Stable on medications for adult ADHD for at least 2 months
- Between 18 and 65 years old
- Be able to give informed consent and comply with study procedures
Who cannot join
- Moderate to severe major depression, clinically significant panic disorder (CGI for depression or panic greater than 4), bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
- Active suicidality (HAM-D suicidality item rated 3 or 4)
- Current substance abuse or dependence
- IQ less than 90
- Suicide risk
- Prior participation in cognitive behavioral therapy for ADHD
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Efficacy of CBT for Residual ADHD in Adults
This study will determine the efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.
Read the detailed description
Attention deficit hyperactivity disorder (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 cognitive behavioral therapy (CBT) is more effective than ADHD education and relaxation techniques in treating adults with ADHD.
Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or training in which they will learn relaxation techniques and receive detailed information about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry and at study completion.
The study is being conducted at Massachusetts General Hospital in Boston and requires 5 assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston on a weekly basis in order to participate in the study.
Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and relaxation techniques.
- Being tested
- Cognitive behavioral therapy (CBT), Relaxation techniques and education about ADHD
- Keywords
- Adult, ADHD, ADD, CBT, Relaxation Techniques, Education
- 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 therapy (CBT)Behavioural
Also called Mastering Your Adult ADHD manual (Safren, et al., 2005)
Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking.
Relaxation techniques and education about ADHDOther
Also called Unpublished treatment manual (Sprich, et al., 2003)
Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Participants will receive cognitive-behavioral therapy following our protocol. Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| Relaxation with Educational Support | Active comparator | Applied relaxation plus educational support (RES). Receives: Other: Relaxation techniques and education about ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-treatment ADHD Symptoms
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: post-treatment (after receiving 12 sessions of treatment)
Secondary outcomes (1)
Maintenance of Gains in CBT Condition
maintenance of gains in CBT condition for those who responded or partially responded as measured by the 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: 12 month follow-up (12 months after baseline assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 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, National Institute of Mental Health (NIMH)
- Investigators
- Steve A. Safren, PhD, Principal investigator, University of MiamiSusan Sprich, PhD, Study director, Partners Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00118911
- Sponsor's protocol ID
- R01MH069812
- Other IDs
- R01MH069812, 2003-P-000523
- Status last verified
- Dec 2017
- First submitted
- 6 Jul 2005
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
PubMed 20736471
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of CBT for Residual ADHD in Adults
- ClinicalTrials.gov ID
- NCT00118911
- Acronym / sponsor ID
- R01MH069812
- Keywords
- Adult, ADHD, ADD, CBT, Relaxation Techniques, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Jul 2005 (estimated)
- Results
- Posted 16 Mar 2011
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 efficacy of cognitive behavioral therapy in treating adults with attention deficit hyperactivity disorder.
Detailed description
Attention deficit hyperactivity disorder (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 cognitive behavioral therapy (CBT) is more effective than ADHD education and relaxation techniques in treating adults with ADHD.
Participants will be randomly assigned to receive 12 to 15 weekly sessions of either CBT or training in which they will learn relaxation techniques and receive detailed information about ADHD. Questionnaires will be used to assess participants' ADHD symptoms at study entry and at study completion.
The study is being conducted at Massachusetts General Hospital in Boston and requires 5 assessment visits and 12 weekly therapy visits. Participants must be able to travel to Boston on a weekly basis in order to participate in the study.
Study hypothesis: CBT is a more efficacious treatment for adult ADHD than education and relaxation techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | Behavioral: Cognitive behavioral therapy (CBT)Participants will receive cognitive-behavioral therapy following our protocol. |
| Relaxation with Educational Support | Active comparator | Other: Relaxation techniques and education about ADHDApplied relaxation plus educational support (RES). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of adult ADHD of at least mild clinical severity (CGI score of 3 or greater)
- Stable on medications for adult ADHD for at least 2 months
- Between 18 and 65 years old
- Be able to give informed consent and comply with study procedures
Key exclusion criteria (6 listed)
- Moderate to severe major depression, clinically significant panic disorder (CGI for depression or panic greater than 4), bipolar disorder, organic mental disorders, psychotic disorders, or pervasive developmental disorders
- Active suicidality (HAM-D suicidality item rated 3 or 4)
- Current substance abuse or dependence
- IQ less than 90
- Suicide risk
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 (CBT)Also: Mastering Your Adult ADHD manual (Safren, et al., 2005)Participants are provided with education about ADHD and instruction in organizational skills, reducing distractibility, and adaptive thinking. | Behavioural | Cognitive-Behavioral Therapy |
| Relaxation techniques and education about ADHDAlso: Unpublished treatment manual (Sprich, et al., 2003)Participants are provided with education about ADHD, instruction in relaxation techniques, and support in applying relaxation techniques to ADHD symptoms. | Other | Relaxation with Educational Support |
Primary outcome
Post-treatment ADHD Symptoms
Time frame: post-treatment (after receiving 12 sessions of treatment)
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.
1 secondary outcome
Maintenance of Gains in CBT Condition
Time frame: 12 month follow-up (12 months after baseline assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20736471Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
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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.
Steve A. Safren, PhD principal investigator
University of Miami
Susan Sprich, PhD study director
Partners Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) and Relaxation techniques and education about ADHD 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 4 inclusion and 6 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 2 Jan 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-treatment ADHD Symptoms (time frame: post-treatment (after receiving 12 sessions of treatment)). 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 NCT00118911, 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 2 Jan 2018.