Adult ADHD Service, South London and Maudsley NHS Foundation Trust
London, Se5 8AZ, United Kingdom
NCT Number: NCT01098058
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).
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
London, Se5 8AZ, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments
Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months
Time frame: week 42
18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
Time frame: week 42
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
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
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
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
The ADHD Beliefs Questionnaire is a measure designed for the study. It consists of 28 items measured on a 5-point Likert Scale. Questions relate to specific beliefs that clinically have been noted to be associated with adult ADHD, e.g. "my lack of concentration will stop me achieving the things that I want".
Time frame: week 42
The ADHD Behaviours Questionnaire is a measure designed for the study. It consists of 29 items measured on a 5-point Likert Scale. Questions relate to specific behaviours that clinically have been noted to be associated with adult ADHD, e.g. "I avoid or put off doing things that I do not find interesting".
Time frame: week 42
The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global self-esteem. It consists of 10 statements related to overall feelings of self-worth or self-acceptance. The items are answered on a four-point scale ranging from strongly agree to strongly disagree.
Time frame: week 42
This is the same as the Adult Barkley Current Behaviour scale but adapted to be completed by an informant.
Time frame: week 42
The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults.
Time frame: Week 42
22 items, each measured on a 5-point Likert scale. The scale has good reliability and validity.
Time frame: week 42
The scale has 12 items assessed on a 7-point Likert scale. It has good reliability and validity.
South London and Maudsley NHS Foundation Trust
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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