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

South London and Maudsley NHS Foundation Trust60 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

CBT plus treatment as usualOTHER

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

Treatment as usualOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Adult ADHD Service, South London and Maudsley NHS Foundation Trust

London, London, United Kingdom

Outcomes

Primary Outcomes

Adult Barkley Current Behaviour Scale (Barkley 2006)

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

Time frame: 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

Time frame: week 42

Secondary Outcomes

Clinical Global Impression Scales (Guy 1976)

The Clinical Global Impression Scale is a 7-point scale that requires the clinician to rate the current severity of the patient's illness , relative to the past experience with patients with the same diagnosis. It is widely used in clinical treatment trials and is reliable and valid. There are severity, improvement and satisfaction versions of the scale. Clinician, independent evaluator will complete severity measure. Participant, clinician, independent evaluator and informant will complete improvement measure; participant will complete satisfaction measure.

Time frame: week 42

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

The CORE-OM is a standardised public domain approach to audit, evaluation and outcome measurement for UK psychological therapy and counselling services. It consists of 34 items measured on a five-point Likert scale and assesses emotional distress and risk over the past week.

Time frame: week 42

Hospital anxiety and depression scale (Zigmond and Snaith 1983)

A reliable and valid 14-item self-report scale assessing anxiety and depression symptoms, scored on a 4-point likert scale.

Time frame: week 42

ADHD Beliefs Questionnaire

Data from ClinicalTrials.gov

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