Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R&D2009/051
Study information
Scientific 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)
Acronym
Study hypothesis
CBT plus treatment as usual will be more effective than treatment as usual alone in
1. reducing ADHD symptoms
2. improving functioning
Please note that as of 20/06/2013, the anticipated end date for this trial was updated from 20/04/2013 to 30/04/2014
20/06/2013: Please note that recruitment for this trial is closed.
Ethics approval
NRES Committee London - City Road and Hampstead approved on the 29th of July 2009 subject to clarifications, substantial amendments were approved on 27th January 2010, 4th August 2010 and 16th August 2011 (ref: 09/H0721/49)
Study design
Single centre interventional open label randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Adult Attention Deficit Hyperactivity Disorder (ADHD)
Intervention
60 participants will be randomly allocated to either:
1. CBT plus treatment as usual
16 one-hour therapy sessions taking place over 30 weeks in addition to usual medical follow-up appointments - typically one 30-minute appointment every three to six months
2. Treatment as usual alone
Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months - taking place over 30 weeks
The total duration of follow up will be 42 weeks (i.e. 12 weeks after the ends of the treatment period).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Adult Barkley Current Behaviour Scale (Barkley 2006)
An 18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
2. Work and Social Adjustment Scale (Mundt et al 2002)
A reliable and valid self-report measure of impaired functioning attributable to an identified problem, consisting of 5 items, each rated on an 8-point scale
All outcomes will be assessed at baseline, 30 and 42 weeks. There is an assessment at the 30-week point also in case of attrition and for further analyses, but 30-week measures will not be used as the main outcomes.
Secondary outcome measures
Current secondary outcome measures as of 03/01/2012
1. Clinical Outcomes in Routine Evaluation Outcome measure (CORE-OM), (Evans et al 2002)
2. Hospital Anxiety and Depression Scale (HADS)
3. ADHD Beliefs Questionnaire
4. ADHD Behaviours Questionnaire
5. Rosenberg Self-Esteem Scale (Rosenberg 1965)
6. Autism Spectrum Quotient (Baron-Cohen et al 2001) *
7. Global Impression scales (improvement** and satisfaction**) (adapted from Guy 1976 and used previously in Deale et al 1997)
8. Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
9. Beliefs about Emotions Questionnaire (Rimes et al 2009)
Rated by nominated informant:
10. Adult Barkley Current Behaviour Scale
11. Global Impression scales (severity and improvement**) (adapted from Guy 1976 and used previously in Deale et al 1997)
Rated by independent evaluator:
12. Global Impression scales (severity and improvement**) (adapted from Guy 1976 and used previously in Deale et al 1997)
13. Global Assessment of Functioning (Axis V, DSM-IV-TR)
this is routinely administered during clinic assessments. This will only be included in the questionnaire pack if, for some reason, it has not already been completed
* baseline only
** 30 and 42 weeks only
Previous secondary outcome measures
1. Clinical Outcomes in Routine Evaluation Outcome measure (CORE-OM), (Evans et al 2002)
2. Hospital Anxiety and Depression Scale (HADS)
3. ADHD Beliefs Questionnaire
4. ADHD Behaviours Questionnaire
5. Rosenberg Self-Esteem Scale (Rosenberg 1965)
6. Autism Spectrum Quotient (Baron-Cohen et al 2001) *
7. Global Impression scales (improvement** and satisfaction**) (adapted from Guy 1976 and used previously in Deale et al 1997)
8. Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
9. Beliefs about Emotions Questionnaire (Rimes et al 2009)
rated by nominated informant:
10. Adult Barkley Current Behaviour Scale
rated by independent evaluator:
11. Global Impression scales (severity and improvement**) (adapted from Guy 1976 and used previously in Deale et al 1997)
12. Global Assessment of Functioning (Axis V, DSM-IV-TR)
All outcomes will be assessed at baseline, 30 and 42 weeks
Overall trial start date
21/04/2010
Overall trial end date
30/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 17/12/2012:
1. Men and women aged 18-65 with 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:
1.1. the participant met DSM-IV criteria for Adult ADHD both in childhood and adulthood
1.2. the participant experienced at least moderate psychological, social and/or educational or occupational impairment in multiple settings
1.3. symptoms occurred in two or more settings including social, familial, educational and/or occupational settings.
2. 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)
3. 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
4. Currently score 6 or more on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale (self-rated)
5. Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
Previous inclusion criteria until 17/12/2012:
1. Men and women aged 18 to 65 who have received a diagnosis of adult ADHD in the Adult ADHD Service at the Maudsley Hospital, London, UK
2. Currently score 6 or more on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale (self-rated)
3. Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)
4. If on medication to be on a stabilised dose as defined by no more than 10% change in medication dose over a two-month period
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Clinically significant anxiety disorder
2. Current episode major depression, current suicidality or self-harm (score of moderate or high suicidality on the M.I.N.I.)
3. Acquired brain injury
4. Primary diagnosis of psychosis or bipolar disorder
5. Pervasive developmental disorder
6. Active substance misuse/dependence in last three months
7. Verbal IQ <80
8. Diagnosis of a personality disorder
9. Participant not willing to comply with the requirements of an RCT
10. If the assessor does not perceive ADHD to be the current primary problem
Recruitment start date
21/04/2010
Recruitment end date
30/04/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Adult ADHD Service
London
SE5 8AZ
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
South London and Maudsley NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25207986
Publication citations
-
Protocol
Dittner AJ, Rimes KA, Russell AJ, Chalder T, Protocol for a proof of concept randomized controlled trial of cognitive-behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone., BMC Psychiatry, 2014, 14, 1, 248, doi: 10.1186/s12888-014-0248-1.