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. 2018 Mar 23;2018(3):CD010840. doi: 10.1002/14651858.CD010840.pub2

ISRCTN03732556.

Trial name or title 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
Methods Two‐arm randomised controlled trial
Participants Sample size: 60 participants
Inclusion criteria

  1. Both clinician and participant agree that randomisation is acceptable

  2. The participant has given written informed consent

  3. The participant is aged 18 to 65

  4. The participant is diagnosed with adult ADHD by a mental health professional

  5. The participant's score on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale (self‐rated) is 6 or more

  6. The participant is rated to have clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)


Exclusion criteria

  1. Clinically significant anxiety disorder and current episode of major depression, significant risk of self‐harm and active substance misuse/dependence in last three months. Participants will also be excluded if they have an acquired brain injury, a primary diagnosis of psychosis or bipolar disorder, a pervasive developmental disorder, a diagnosis of a personality disorder or any other primary clinical diagnosis whereby participation in the trial would be inappropriate to their clinical needs.

  2. Verbal IQ of less than 80.

  3. Patients who are considered by the research psychologist in discussion with the principal investigator to be unable to participate.
Interventions TAU plus 16 sessions of individual CBT vs TAU alone
Outcomes Primary outcomes, rated by participant (self‐report)

  1. ADHD current symptoms

  2. Work and social adjustment


Secondary outcomes, rated by participant (self‐report)

  1. Psychological distress

  2. Anxiety and depression

  3. ADHD cognitions

  4. ADHD behaviours

  5. Self‐esteem

  6. Autism spectrum symptoms

  7. Global impression

  8. Perfectionism

  9. Beliefs about emotions


Nominated informant ratings

  1. ADHD current symptoms

  2. Global impression


Independent evaluator ratings

  1. Global impression

  2. Global functioning


Therapist ratings

  1. CBT compliance and adherence

  2. Global Impression


Other

  1. Medications and doses

  2. The details of TAU for all participants, i.e. number of sessions with the service managing their ADHD (the Maudsley Adult ADHD Service or their local service) will be recorded.
Starting date ISRCTN register number: ISRCTN03732556, assigned 4 November 2010
Start date: 21 April 2010
End date: 30 April 2014
Recruitment status: no longer recruiting
Contact information Principal investigator: Dr Antonia J Dittner
Email: antonia.dittner@slam.nhs.uk
Address: King's College London, King's Health Partners, Behavioural and Developmental Psychiatry Clinical Academic Group, Maudsley Adult ADHD Service, South London and Maudsley NHS Foundation Trust, London, UK
Notes Funding source: South London and Maudsley NHS Foundation Trust (UK)
Declarations of interest: not reported