Condition category
Mental and Behavioural Disorders
Date applied
01/04/2010
Date assigned
04/11/2010
Last edited
11/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Antonia Dittner

ORCID ID

Contact details

Adult ADHD Service
Maudsley Hospital
London
SE5 8AZ
United Kingdom

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 measures

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

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

Sponsor information

Organisation

South London and Maudsley NHS Foundation Trust (UK)

Sponsor details

Bethlem Royal Hospital
Monks Orchard Road
Beckenham
Kent
BR3 3BX
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25207986

Publication citations

  1. 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.

Additional files

Editorial Notes