Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD): a Randomised Controlled Trial

ISRCTN	ISRCTN03732556
DOI	https://doi.org/10.1186/ISRCTN03732556
Protocol serial number	R&D2009/051
Sponsor	South London and Maudsley NHS Foundation Trust (UK)
Funder	South London and Maudsley NHS Foundation Trust (UK)

Submission date: 01/04/2010
Registration date: 04/11/2010
Last edited: 16/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Antonia Dittner
Scientific

Adult ADHD Service
Maudsley Hospital
London
SE5 8AZ
United Kingdom

Study information

Primary study design	Interventional
Study design	Single centre interventional open label randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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)
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/04/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	21/04/2010
Date of final enrolment	30/04/2014

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Adult ADHD Service

London
SE5 8AZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2018		Yes	No
Protocol article	protocol	03/09/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/10/2018: Publication reference added.