Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)

NCT01098058 | Completed DMC

• 1 other identifier: 09/H0721/49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Adult attention deficit hyperactivity disorder; cognitive-behavioural therapy; randomised controlled trial

Outcome Measures

Primary Outcomes (2)

• Adult Barkley Current Behaviour Scale (Barkley 2006)

  18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale

  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

  week 42

Secondary Outcomes (10)

• Clinical Global Impression Scales (Guy 1976)

  week 42

• Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)

  week 42

• Hospital anxiety and depression scale (Zigmond and Snaith 1983)

  week 42

• ADHD Beliefs Questionnaire

  week 42

• ADHD Behaviours Questionnaire

  week 42

Study Arms (2)

CBT plus treatment as usual

EXPERIMENTAL

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

Other: Treatment as usual

Interventions

CBT plus treatment as usual OTHER

16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments

CBT plus treatment as usual

Treatment as usual OTHER

Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• South London and Maudsley NHS Foundation Trust: lead

Study Sites (1)

Adult ADHD Service, South London and Maudsley NHS Foundation Trust

London, London, Se5 8AZ, United Kingdom

Location

Related Publications (7)

• Barkley R.A. (2006) Attention-Deficit Hyperactivity Disorder - A Handbook for Diagnosis and Treatment. Third Edition, The Guildford Press, New York.

  BACKGROUND

• Rosenberg, M. (1965). Society and The Adolescent Self-Image. Princeton, N.J.: Princeton University Press.

  BACKGROUND

• Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, 2000.

  BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• Evans 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.

  PMID: 11772852 BACKGROUND

• Guy 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

• 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.

  PMID: 11983645 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Antonia J Dittner, D Clin Psy

  South London and Maudsley NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Psychologist

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

GB (1)