Attention Deficit Hyperactivity Disorder Clinical Trial
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)
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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