Attention Deficit Hyperactivity DisorderNCT01098058
Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)
A study testing CBT plus treatment as usual and Treatment as usual in people with Attention Deficit Hyperactivity Disorder, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of the study is to compare the effectiveness of cognitive-behavioural therapy (CBT) plus treatment as usual with treatment as usual only in treating adults with attention deficit hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- CBT plus treatment as usual and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Sep 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of adult ADHD according to NICE guidelines i.e. if there was evidence from both the participant and the informant (where available) that 1) the participant met DSM-IV criteria for Adult ADHD both in childhood and adulthood 2) that they experienced at least moderate psychological, social and/or educational or occupational impairment in multiple settings and 3) symptoms occurred in two or more settings including social, familial, educational and/or occupational settings. Participants will have received a diagnosis either from the Adult ADHD Service, Maudsley Hospital, London, UK or another specialist/secondary care service (in this case a copy of the diagnostic report will be required). Participants will either already be attending follow-up clinics, including psychoeducation workshops, or will have been recently referred to the service for medication follow-up or psychological treatment.
- Currently score 6 or more on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale
- Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
- Able to attend the clinic regularly and reliably
Who cannot join
- Clinically significant anxiety disorder
- Current episode major depression, current suicidality or self-harm (score of moderate or high suicidality on the M.I.N.I.)
- Acquired brain injury
- Primary diagnosis of psychosis or bipolar disorder
- Pervasive developmental disorder(score of <= 32 on Autism Spectrum Quotient - although if the assessor judges that items that confound with ADHD have caused the score to be elevated, people with scores >=32 can still enter the trial)
- Diagnosis of personality disorder
Show all 10Show fewer
- Active substance misuse/dependence in last three months
- Verbal IQ <80
- Not able to comply with the requirements of a randomised controlled trial
- If the assessor does not perceive ADHD to be the primary problem
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Adult ADHD Service, South London and Maudsley NHS Foundation Trust
London, London, Se5 8AZ
About this study
Official title: A Proof of Concept Randomised Controlled Trial to Examine the Potential Efficacy, Patient Acceptability and Feasibility of Cognitive-behavioural Therapy for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of the study is to compare the effectiveness of cognitive-behavioural therapy (CBT) plus treatment as usual with treatment as usual only in treating adults with attention deficit hyperactivity disorder (ADHD).
Read the detailed description
Approximately 50% of individuals with adult ADHD are not able to tolerate, do not respond to, or fail to reach optimal outcomes on medication alone (Spencer, Biederman and Wilens 2000). The NICE guidelines for adult ADHD, released in September 2008, emphasise the need for further such research into psychological approaches to treatment of the condition.
There is promising preliminary evidence that suggests that psychological approaches to treatment are effective in individuals with Adult ADHD (see Weiss et al 2008 for a review). So far, however, only one randomised controlled trial of CBT has been carried out (Safren, Otto et al 2005). Thirty-one participants were randomised to receive either CBT and medication as usual or medication alone. Those randomised to CBT (n=16) had significantly lower ADHD symptoms (as rated by an independent investigator), global severity and self-rated symptoms than those on medication only (ps range <0.01 to <0.002). Those in the CBT group also had significantly lower scores on independently- and self-rated measures of mood (ps range <0.01 to 0.04).
There is a need for more randomised controlled trials to be carried out in order to replicate Safren et al's result in a different site, to further investigate the feasibility of CBT in this population and to further develop CBT approaches to this condition.
Studies carried out so far have tended to be skills-based (i.e. sessions focused on teaching specific skills such as time management), rather than formulation-driven (a formulation is essentially a shared hypothesis as to the relationships between the individual's experience, beliefs, behaviour and emotions).
The current study aims to evaluate a formulation-driven approach to CBT for adults with ADHD. A group of individuals (n = 30) receiving CBT combined with treatment as usual for adults with ADHD will be compared with a group receiving treatment as usual only (n= 30), employing a randomized design.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- CBT plus treatment as usual, Treatment as usual
- Keywords
- Adult attention deficit hyperactivity disorder, cognitive-behavioural therapy, randomised controlled trial
- 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 plus treatment as usualOther
16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments
Treatment as usualOther
Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months
| Study group | Role | What they receive |
|---|---|---|
| CBT plus treatment as usual | Experimental | Not described Receives: Other: CBT plus treatment as usual |
| Treatment as usual | Active comparator | Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Barkley Current Behaviour Scale (Barkley 2006)
18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
Measured: week 42
Work and Social Adjustment Scale (Mundt et al 2002)
A reliable and valid self-report measure of impaired functioning attributable to an identified problem.
It consists of 5 items, each rated on an 8-point scale
Measured: week 42
Secondary outcomes (10)
Clinical Global Impression Scales (Guy 1976)
The Clinical Global Impression Scale is a 7-point scale that requires the clinician to rate the current severity of the patient's illness , relative to the past experience with patients with the same diagnosis. It is widely used in clinical treatment trials and is reliable and valid.
There are severity, improvement and satisfaction versions of the scale. Clinician, independent evaluator will complete severity measure. Participant, clinician, independent evaluator and informant will complete improvement measure; participant will complete satisfaction measure.
Measured: week 42
Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)
The CORE-OM is a standardised public domain approach to audit, evaluation and outcome measurement for UK psychological therapy and counselling services. It consists of 34 items measured on a five-point Likert scale and assesses emotional distress and risk over the past week.
Measured: week 42
Hospital anxiety and depression scale (Zigmond and Snaith 1983)
A reliable and valid 14-item self-report scale assessing anxiety and depression symptoms, scored on a 4-point likert scale.
Measured: week 42
ADHD Beliefs Questionnaire
The ADHD Beliefs Questionnaire is a measure designed for the study. It consists of 28 items measured on a 5-point Likert Scale. Questions relate to specific beliefs that clinically have been noted to be associated with adult ADHD, e.g. "my lack of concentration will stop me achieving the things that I want".
Measured: week 42
ADHD Behaviours Questionnaire
The ADHD Behaviours Questionnaire is a measure designed for the study. It consists of 29 items measured on a 5-point Likert Scale. Questions relate to specific behaviours that clinically have been noted to be associated with adult ADHD, e.g. "I avoid or put off doing things that I do not find interesting".
Measured: week 42
Rosenberg Self-Esteem Scale (Rosenberg 1965)
The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global self-esteem. It consists of 10 statements related to overall feelings of self-worth or self-acceptance. The items are answered on a four-point scale ranging from strongly agree to strongly disagree.
Measured: week 42
Informant-rated Adult Barkley Current Behaviour Scale (Barkley 2006)
This is the same as the Adult Barkley Current Behaviour scale but adapted to be completed by an informant.
Measured: week 42
Global assessment of functioning scale, DSM IV-TR
The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults.
Measured: week 42
Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
22 items, each measured on a 5-point Likert scale. The scale has good reliability and validity.
Measured: Week 42
Beliefs about Emotions Questionnaire (Rimes et al 2009)
The scale has 12 items assessed on a 7-point Likert scale. It has good reliability and validity.
Measured: week 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Dittner, South London and Maudsley NHS Foundation Trust
- Investigators
- Antonia J Dittner, D Clin Psy, Principal investigator, South London and Maudsley NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098058
- Sponsor's protocol ID
- 09/H0721/49
- Status last verified
- Apr 2016
- First submitted
- 19 Mar 2010
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barkley R.A. (2006) Attention-Deficit Hyperactivity Disorder - A Handbook for Diagnosis and Treatment. Third Edition, The Guildford Press, New York.
Rosenberg, M. (1965). Society and The Adolescent Self-Image. Princeton, N.J.: Princeton University Press.
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, 2000.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51.
PubMed 11772852Guy W (ed). ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976.
Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
PubMed 11983645
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Randomised Controlled Trial to Examine the Potential Efficacy, Patient Acceptability and Feasibility of Cognitive-behavioural Therapy for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01098058
- Acronym / sponsor ID
- 09/H0721/49
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Adult attention deficit hyperactivity disorder, cognitive-behavioural therapy, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Apr 2010 (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 the study is to compare the effectiveness of cognitive-behavioural therapy (CBT) plus treatment as usual with treatment as usual only in treating adults with attention deficit hyperactivity disorder (ADHD).
Detailed description
Approximately 50% of individuals with adult ADHD are not able to tolerate, do not respond to, or fail to reach optimal outcomes on medication alone (Spencer, Biederman and Wilens 2000). The NICE guidelines for adult ADHD, released in September 2008, emphasise the need for further such research into psychological approaches to treatment of the condition.
There is promising preliminary evidence that suggests that psychological approaches to treatment are effective in individuals with Adult ADHD (see Weiss et al 2008 for a review). So far, however, only one randomised controlled trial of CBT has been carried out (Safren, Otto et al 2005). Thirty-one participants were randomised to receive either CBT and medication as usual or medication alone. Those randomised to CBT (n=16) had significantly lower ADHD symptoms (as rated by an independent investigator), global severity and self-rated symptoms than those on medication only (ps range <0.01 to <0.002). Those in the CBT group also had significantly lower scores on independently- and self-rated measures of mood (ps range <0.01 to 0.04).
There is a need for more randomised controlled trials to be carried out in order to replicate Safren et al's result in a different site, to further investigate the feasibility of CBT in this population and to further develop CBT approaches to this condition.
Studies carried out so far have tended to be skills-based (i.e. sessions focused on teaching specific skills such as time management), rather than formulation-driven (a formulation is essentially a shared hypothesis as to the relationships between the individual's experience, beliefs, behaviour and emotions).
The current study aims to evaluate a formulation-driven approach to CBT for adults with ADHD. A group of individuals (n = 30) receiving CBT combined with treatment as usual for adults with ADHD will be compared with a group receiving treatment as usual only (n= 30), employing a randomized design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT plus treatment as usual | Experimental | Other: CBT plus treatment as usual |
| Treatment as usual | Active comparator | Other: Treatment as usualTreatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of adult ADHD according to NICE guidelines i.e. if there was evidence from both the participant and the informant (where available) that 1) the participant met DSM-IV criteria for Adult ADHD both in childhood and adulthood 2) that they experienced at least moderate psychological, social and/or educational or occupational impairment in multiple settings and 3) symptoms occurred in two or more settings including social, familial, educational and/or occupational settings. Participants will have received a diagnosis either from the Adult ADHD Service, Maudsley Hospital, London, UK or another specialist/secondary care service (in this case a copy of the diagnostic report will be required). Participants will either already be attending follow-up clinics, including psychoeducation workshops, or will have been recently referred to the service for medication follow-up or psychological treatment.
- Currently score 6 or more on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale
- Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
- Able to attend the clinic regularly and reliably
Key exclusion criteria (10 listed)
- Clinically significant anxiety disorder
- Current episode major depression, current suicidality or self-harm (score of moderate or high suicidality on the M.I.N.I.)
- Acquired brain injury
- Primary diagnosis of psychosis or bipolar disorder
- Pervasive developmental disorder(score of <= 32 on Autism Spectrum Quotient - although if the assessor judges that items that confound with ADHD have caused the score to be elevated, people with scores >=32 can still enter the trial)
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 plus treatment as usual16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments | Other | CBT plus treatment as usual |
| Treatment as usualTreatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months | Other | Treatment as usual |
Primary outcome
Adult Barkley Current Behaviour Scale (Barkley 2006)
Time frame: week 42
18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
Work and Social Adjustment Scale (Mundt et al 2002)
Time frame: week 42
A reliable and valid self-report measure of impaired functioning attributable to an identified problem. It consists of 5 items, each rated on an 8-point scale
10 secondary outcomes
Clinical Global Impression Scales (Guy 1976)
Time frame: week 42
Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)
Time frame: week 42
Hospital anxiety and depression scale (Zigmond and Snaith 1983)
Time frame: week 42
ADHD Beliefs Questionnaire
Time frame: week 42
ADHD Behaviours Questionnaire
Time frame: week 42
Rosenberg Self-Esteem Scale (Rosenberg 1965)
Time frame: week 42
Informant-rated Adult Barkley Current Behaviour Scale (Barkley 2006)
Time frame: week 42
Global assessment of functioning scale, DSM IV-TR
Time frame: week 42
Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
Time frame: Week 42
Beliefs about Emotions Questionnaire (Rimes et al 2009)
Time frame: week 42
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 19 Apr 2016.
- BackgroundBarkley R.A. (2006) Attention-Deficit Hyperactivity Disorder - A Handbook for Diagnosis and Treatment. Third Edition, The Guildford Press, New York.
- BackgroundRosenberg, M. (1965). Society and The Adolescent Self-Image. Princeton, N.J.: Princeton University Press.
- BackgroundDiagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, 2000.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 11772852Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51.
- BackgroundGuy W (ed). ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976.
- Background: PubMed 11983645Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
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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.
Antonia J Dittner, D Clin Psy principal investigator
South London and Maudsley NHS Foundation Trust
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 plus treatment as usual and Treatment as usual in people with Attention Deficit Hyperactivity Disorder, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
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 10 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 19 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 United Kingdom. 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?
Adult Barkley Current Behaviour Scale (Barkley 2006) (time frame: week 42). The study lists 2 primary outcomes in all. 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 NCT01098058, which also lists 7 linked publications.
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 19 Apr 2016.