Clinical trial NCT01098058: Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)
Official 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Adult attention deficit hyperactivity disorder
cognitive-behavioural therapy
randomised controlled trial
Lead sponsor: South London and Maudsley NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Approximately 50% of individuals with adult ADHD are not able to tolerate, do not respond to, or fail to reach optimal outcomes on medication alone (Spencer, Biederman and Wilens 2000). The NICE guidelines for adult ADHD, released in September 2008, emphasise the need for further such research into psychological approaches to treatment of the condition.

There is promising preliminary evidence that suggests that psychological approaches to treatment are effective in individuals with Adult ADHD (see Weiss et al 2008 for a review). So far, however, only one randomised controlled trial of CBT has been carried out (Safren, Otto et al 2005). Thirty-one participants were randomised to receive either CBT and medication as usual or medication alone. Those randomised to CBT (n=16) had significantly lower ADHD symptoms (as rated by an independent investigator), global severity and self-rated symptoms than those on medication only (ps range \<0.01 to \<0.002). Those in the CBT group also had significantly lower scores on independently- and self-rated measures of mood (ps range \<0.01 to 0.04).

There is a need for more randomised controlled trials to be carried out in order to replicate Safren et al's result in a different site, to further investigate the feasibility of CBT in this population and to further develop CBT approaches to this condition.

Studies carried out so far have tended to be skills-based (i.e. sessions focused on teaching specific skills such as time management), rather than formulation-driven (a formulation is essentially a shared hypothesis as to the relationships between the individual's experience, beliefs, behaviour and emotions).

The current study aims to evaluate a formulation-driven approach to CBT for adults with ADHD. A group of individuals (n = 30) receiving CBT combined with treatment as usual for adults with ADHD will be compared with a group receiving treatment as usual only (n= 30), employing a randomized design.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adult Barkley Current Behaviour Scale (Barkley 2006)
timeFrame: week 42
measure: Work and Social Adjustment Scale (Mundt et al 2002)
timeFrame: week 42
Secondary outcomes:
measure: Clinical Global Impression Scales (Guy 1976)
timeFrame: week 42
measure: Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)
timeFrame: week 42
measure: Hospital anxiety and depression scale (Zigmond and Snaith 1983)
timeFrame: week 42
measure: ADHD Beliefs Questionnaire
timeFrame: week 42
measure: ADHD Behaviours Questionnaire
timeFrame: week 42
measure: Rosenberg Self-Esteem Scale (Rosenberg 1965)
timeFrame: week 42
measure: Informant-rated Adult Barkley Current Behaviour Scale (Barkley 2006)
timeFrame: week 42
measure: Global assessment of functioning scale, DSM IV-TR
timeFrame: week 42
measure: Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
timeFrame: Week 42
measure: Beliefs about Emotions Questionnaire (Rimes et al 2009)
timeFrame: week 42
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Adult ADHD Service, South London and Maudsley NHS Foundation Trust
Study officials:
affiliation: South London and Maudsley NHS Foundation Trust
name: Antonia J Dittner, D Clin Psy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barkley R.A. (2006) Attention-Deficit Hyperactivity Disorder - A Handbook for Diagnosis and Treatment. Third Edition, The Guildford Press, New York.
citation: Rosenberg, M. (1965). Society and The Adolescent Self-Image. Princeton, N.J.: Princeton University Press.
citation: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, 2000.
citation: 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.
citation: 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.
citation: 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.
citation: 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.