TY - JOUR
T1 - 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.
AU - Dittner, Antonia J.
AU - Rimes, Katherine A.
AU - Russell, Ailsa J.
AU - Chalder, Trudie
PY - 2014/9/3
Y1 - 2014/9/3
N2 - 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.
AB - 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.
UR - http://dx.doi.org/10.1186/s12888-014-0248-1
U2 - 10.1186/s12888-014-0248-1
DO - 10.1186/s12888-014-0248-1
M3 - Article
SN - 1471-244X
VL - 14
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
M1 - 248
ER -