Protocol for a proof of concept randomized controlled trial of cognitive-behavioural therapy for adult ADHD as a supplement to treatment as usual, compared with treatment as usual alone.

Background: ADHD is prevalent in adults and frequently associated with impairment and distress. While medication is often the first line of treatment a high proportion of people with the condition are not fully treated by medication alone, cannot tolerate medication or do not wish to take it. Preliminary studies suggest that psychosocial approaches are a promising adjunctive or alternative treatment option. To date, individual cognitive-behaviour therapy (CBT) has been found to be efficacious in three randomized controlled trials (RCTs). There is a need for more RCTs to be carried out in order to replicate these results in different sites, to further investigate the acceptability and feasibility of CBT in this population and to further develop CBT approaches based on a psychological model. This randomized controlled trial investigates the efficacy of individual, formulation-based CBT when added to treatment-as-usual as compared with treatment as usual alone.

Methods/design: Sixty patients with a diagnosis of adult ADHD attending a specialist clinic are randomly allocated to 1 of 2 treatments, 'Treatment as Usual' (TAU) or TAU plus 16 sessions individual CBT (TAU + CBT). In the TAU + CBT, the first 15 sessions take place over 30 weeks with a 16th 'follow-up' session at 42 weeks. Outcomes are assessed at 30 weeks and 42 weeks following randomization. The two primary outcomes are self-rated ADHD symptoms and functioning (occupational and social). Secondary outcomes include distress, mood, ADHD-related cognitions, ADHD-related behaviours and informant-rated ADHD symptoms. The primary analysis will include all participants for whom data is available and will use longitudinal regression models to compare treatments. Secondary outcomes will be analysed similarly.

Discussion: The results of the study will provide information about a) whether CBT adds benefit over and above TAU for ADHD and, b) if CBT is found to be efficacious, potential mechanisms of change and predictors of efficacy.

Trial Registration: Current Controlled Trials ISRCTN03732556, assigned 04/11/2010.