Dittner et al.

BMC Psychiatry 2014, 14:248

http://www.biomedcentral.com/1471-244X/14/248

STUDY PROTOCOL Open Access

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
Antonia J Dittner1*, Katharine A Rimes2, Ailsa J Russell3 and Trudie Chalder4

Abstract
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
Keywords: Adult attention deficit hyperactivity disorder, Adult ADHD, Cognitive behavioural therapy, Randomized
controlled trial, Psychosocial treatment, Psychological treatment, Psychotherapy

* Correspondence: antonia.dittner@slam.nhs.uk
1
King’s College London, King’s Health Partners, Behavioural and
Developmental Psychiatry Clinical Academic Group, Maudsley Adult ADHD
Service, South London and Maudsley NHS Foundation Trust, London, UK
Full list of author information is available at the end of the article

© 2014 Dittner et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
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Background treatment. All showed improvements on self-rated ADHD

Introduction symptoms while some also demonstrated improvements
Although Attention Deficit Hyperactivity Disorder (ADHD) in independently-rated ADHD symptoms, in objective
was originally identified in children, it is increasingly re- measures of cognitive functioning and in self-rated associ-
cognised that symptoms may persist into adulthood. The ated problems such as low mood and anxiety. Two studies
disorder is frequently associated with impairment, distress also demonstrated that improvements were maintained at
and psychiatric co-morbidity [1,2]. Estimates of prevalence follow-up [18,20].
range from 2.5% to 4% cross-nationally [3]. So far, to the authors’ knowledge, there have been only
Medication is the first line treatment for ADHD in three RCTs of individual CBT [24-26]. Safren et al. [24]
adults. However, approximately 50% of individuals with and [25] carried out two RCTs investigating the effect-
adult ADHD are not able to tolerate, do not respond to, iveness of individual, manualised treatment based on a
or fail to reach optimal outcomes on medication alone cognitive behavioural model of ADHD symptoms. Al-
[4]. The NICE guidelines for adult ADHD, released in though ADHD specific and using a range of cognitive-
September 2008, recommend that medication be com- behavioural strategies for intervention, the approach was
plemented by group and individual CBT and emphasise educational and therapist directed rather than individual,
the need for further research into psychological approa- formulation driven CBT. For example, information about
ches to treat the condition [5]. the role of unhelpful thoughts and coping in general was
There is promising preliminary evidence suggesting provided but these were not explicitly linked to the ‘idio-
that psychological treatment approaches are of benefit syncratic’ thoughts and behaviours pertinent to each case.
for individuals with Adult ADHD [6,7]. A range of short- Nonetheless, Safren et al., [24] found that participants ran-
term, structured therapies, designed to target the specific domized to CBT and medication as usual (n = 16) had sig-
issues experienced by adults with ADHD have been inves- nificantly lower clinician rated ADHD symptoms when
tigated regarding their impact on self- or independently- compared with those randomized to medication alone
rated ADHD symptoms, as well as other outcomes includ- Large effect sizes (1.2, and 1.7) for between groups change
ing self-esteem, anger management and mood. scores were found on clinician and self-rated ADHD
Some of these results are from open-label uncontrolled symptoms respectively. Those in the CBT group also had
studies [8-13] which evaluated individual CBT, metacog- significantly lower scores on independently- and self-rated
nitive therapy, modified dialectical behavioural therapy measures of mood. In a subsequent study, Safren et al.
(DBT) and mindfulness-based meditation training. All [25] compared CBT and medication as usual to a control
found that following the interventions, participants re- psychological treatment i.e. relaxation with educational
ported improvements in self- and other-rated ADHD support and medication. Results provided support for
symptoms. There were also improvements in outcomes greater improvements in the CBT condition rather than
such as anxiety, depression and functioning. relaxation with educational support condition.
Other studies have compared potentially efficacious Similarly the study by Virta et al. investigated a man-
treatments with a control group using a non-randomized ualised approach which was not formulation driven, al-
design. The studies include group treatments of psycho- though the topics of a few sessions were chosen by the
education [14,15]and modified DBT [16]. All found participants. CBT was compared with cognitive training
improvements in outcomes in the treatment group (in- and no treatment/waitlist conditions. More participants
cluding disorganisation, inattention, emotional lability, in the CBT condition improved compared with the other
knowledge about the condition, self efficacy and self- two conditions. Both active conditions showed a signifi-
esteem) compared with the control group. Limitations of cant decrease in ADHD symptoms but CBT was super-
all the studies include small sample sizes and the non- ior in efficacy for decreasing ADHD symptoms.
randomized designs. In their 2010 review, Knouse and Safren noted that
the treatments with the largest effect sizes commonly
Randomized controlled trials comprise short-term, highly structured programmes with
There have been seven RCTs of group treatments and an emphasis on teaching specific skills and strategies
these include cognitive remediation programmes [17,18] and practice outside the session [6].
metacognitive therapy [19] reasoning and rehabilitation
[20], DBT [21] and mindfulness based therapies [22,23]. Rationale for the current study
All groups were structured and manualised. Specific The psychological treatments developed and evaluated
skills were taught in each and rehearsal of these skills thus far by RCTs have tended to be skills-based i.e.
was encouraged. All studies found statistically signifi- sessions focused on teaching specific skills to combat
cant improvements on the main outcomes in the treat- the symptoms of ADHD such as training in organising
ment group compared with the control group following and planning. However, the emotional and behavioural
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problems experienced by adults with ADHD often extend and this minimises the possibility of provoking shame or a
far beyond the impact of the core symptoms themselves. defensive reaction. This individualised approach improves
ADHD in adulthood is the persistence of a childhood the client’s understanding of their difficulties and reduces
condition which has often had a wide-ranging effect on the potential for relapse. This approach would also make
an individual’s emotional, social and cognitive develop- it likely that some of the co-morbidities would be ad-
ment. For example children with ADHD commonly ex- dressed during treatment such as anxiety and low mood.
perience difficulties at school related to their symptoms While the RCTs of individual CBT so far have used
and may receive negative feedback from parents, teachers treatment models, to the authors’ knowledge none has
and peers. This may lead to the development of negative used a formulation-based approach in order to identify
self-beliefs which persist into adulthood. Consistent with and modify idiosyncratic underlying beliefs (conditional
this, it is not uncommon to encounter in adults with assumptions, core beliefs) and compensatory strategies.
ADHD emotional problems such as depression, anxiety Formulation-based approaches to ADHD have been de-
and low self-esteem and concurrent maladaptive coping scribed and found to be helpful in previous uncontrolled
responses [27]. studies [9,10,12] but this has not been investigated using
Individual cognitive behavioural therapy is recommen- a randomized controlled design.
ded in NICE and other guidelines for ‘common mental The current study therefore aims to develop and eval-
health problems’ such as anxiety and depression. At the uate a collaborative, formulation-based approach to trea-
heart of individual CBT is the development of an indi- ting adult ADHD. A group of individuals receiving CBT
vidual formulation (the formulation-based approach) in combined with treatment as usual for adults with ADHD
collaboration with the client. Although disorder-specific will be compared with a group receiving treatment as
CBT protocols exist for certain emotional disorders of usual only, employing a randomized design. Detailed
mild-moderate severity, individual formulation is still cognitive-behavioural assessments as well as informa-
important and particularly so for more complex cases or tion about cognitions and behaviours from a measure
conditions of greater severity. developed in a concurrent study will inform the con-
The formulation is essentially a shared hypothesis as tent of the intervention. Therapists will also have ac-
to the relationships between the individual’s predispo- cess to a range of skills-based approaches, as have
sition (e.g. cognitive strengths and weaknesses, persona- been used in previous studies, as and when indicated
lity attributes), their experiences, and how these have by the formulation, and a treatment manual is being
contributed to the development of certain beliefs, behav- produced which will be updated iteratively.
iours, emotions and physical reactions. In addition to
this developmental aspect, the formulation specifies the Cognitive behavioural process of treatment
possible influence of these beliefs and behaviours on Mechanisms of change
maintaining ADHD symptoms, impairments in daily While common elements of the most effective treatments
functioning and distress. Treatment is then tailored to have been noted, previous studies have not formally inves-
the individual and focuses on the idiosyncratic problem- tigated mechanisms of change. For example, do symptoms
atic behaviours and thoughts identified in the detailed and distress improve because people have learned more
assessment, while drawing on a range of evidence-based effective skills in managing their symptoms? Do negative
strategies. automatic thoughts about the condition (for example ‘my
In relation to ADHD, a formulation-based approach ADHD will stop me from doing the things I want to
may be structured and teach specific skills and strate- do’), underlying beliefs about the self (for example ‘I
gies, but it would also entail a detailed assessment to am a failure’) and associated compensatory strategies
identify the main problems experienced by the individual need to be changed for CBT to be effective? It is hoped
patient which then allows them to be targeted directly. the current study will shed light on the mechanisms of
The formulation allows the client and therapist to col- successful CBT for adult ADHD.
laboratively address the core symptoms of ADHD using
education, adaptations to the client’s environment and
repetition of adaptive skills in order to compensate for Predictors of outcome
executive dysfunction. In addition it allows for the iden- We will assess demographics, co-morbidity and other
tification and modification of beliefs (e.g. ‘I cannot con- clinical factors at baseline to examine whether they are
centrate so there is no point trying’) and behaviours (e.g. associated with a poorer outcome.
procrastination) that may be serving to maintain problems
and associated distress. The therapist can help the client Aims
make links between their beliefs and pertinent early life To investigate efficacy, patient acceptability and feasibil-
experiences in a compassionate and understanding way ity of a formulation-based cognitive-behavioural therapy
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for adults with attention deficit hyperactivity disorder NB for brevity, the rest of protocol will refer to the
(ADHD). two treatments as CBT and TAU rather than CBT plus
A secondary aim is to investigate the predictors of out- TAU and TAU alone.
come and mechanisms of change. Each participant will be assessed and participants who
give informed consent will be randomly allocated to one
of two treatments. Treatment will start as soon as pos-
Hypothesis of efficacy
sible after randomization. The final outcome measure
CBT plus treatment as usual will be more effective than
will be at 42 weeks after randomization.
treatment as usual alone in i) reducing ADHD symp-
toms ii) improving functioning.
Flow chart of trial design
See Figure 1.
Methods/design
Trial design
A two-arm randomized controlled trial of patients who Recruitment
meet DSM IV criteria for adult ADHD. Participants will We will study 60 participants over approximately three
be randomly assigned to one of two treatment arms. The years. All will have received a diagnosis of adult ADHD,
first condition is treatment as usual (TAU). TAU will often either in the Adult ADHD Service or elsewhere (in this
but not always be pharmacotherapy, overseen either by case a copy of the diagnostic report will be required
the ADHD service in which the research is being carried showing external validation of childhood onset). Partici-
out, the participant’s local adult ADHD Service, a com- pants will either already be attending follow-up clinics in
munity mental health team or a general practitioner. The the Service, including psychoeducation workshops, or
second condition is TAU and in addition sixteen sessions will have been recently referred to the service for medi-
of CBT. cation follow-up or psychological treatment.

Assess for eligibility

Exclusion

Randomization

TAU 15 sessions CBT plus TAU

Post-treatment assessment at 30-weeks

16th CBTsession at
42 weeks

Post-treatment assessment at 42 weeks

Figure 1 Flow diagram of trial design.

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The psychoeducation workshops include group dis- to comply with the requirements of an RCT
cussion, didactic teaching and provision of written mate- (e.g. are not able to attend regularly and reliably for
rials and cover topics such as what it means to have assessment and treatment sessions), who are
ADHD, relationships, emotions (anger/frustration, low currently undergoing another talking therapy for
mood, anxiety) and ADHD, time management, problem- adult ADHD or any other psychiatric disorder, who
solving, relationships and the future with ADHD. Broadly are unable to speak English at an adequate level to
they follow the format described in a previous study [6] participate in the trial will be excluded.
with some adaptations. Results from previous studies sug-
gest that psychoeducation alone, even when developed Eligibility will be established according to the inclusion
specifically for ADHD, does not have a significant impact and exclusion criteria. For pragmatic reasons, to maximize
on ADHD symptoms, maybe because it does not incorp- recruitment, it was decided not to have inclusion/exclu-
orate learning and practice of specific skills. It is thought sion criteria related to the use or otherwise of medication
approximately 10-20% of participants will have attended or the stabilisation or otherwise of the dose. Use of medi-
the psychoeducation programme prior to taking part in cation will be routinely recorded and it is anticipated that
the trial, however any effects of this are likely to be distrib- any variation in use of medication will be accounted for
uted equally across the two treatment arms owing to the controlled for in the randomized design.
randomized design.
Procedures
Inclusion criteria Individuals likely to meet eligibility criteria for the study
will be given an information sheet about the treatment
1. Both clinician and participant agree that trial by their doctor and invited to take part. Potential
randomization is acceptable. participants will attend an assessment appointment with
2. The participant has given written informed consent. a research psychologist to ascertain eligibility for the
3. The participant is aged 18 to 65. study. If the patient understands the purpose of the trial
4. The participant is diagnosed with adult ADHD by a and is willing to give informed consent to be random-
mental health professional. ized, treated and followed up, they will sign the consent
5. The participant’s score on the inattentive or form to participate in the trial.
hyperactive/impulsive subscale of the Adult Barkley
Current Behaviour Scale (self-rated) is 6 or more. Eligibility assessment
6. The participant is rated to have clinical severity of at A battery of self-report measures and two structured
least a moderate level (Clinical Global Impression diagnostic interviews will be administered. The Mini-
score of 4 or above). International Neuropsychiatric Interview (M.I.N.I.) as-
sesses for co-morbid psychiatric diagnoses and takes
Exclusion criteria approximately 15 minutes [28]. Conners’ Adult ADHD
Diagnostic Interview for DSM-IV (CAADID) aids in
1. The research psychologist will use a standardized diagnosing ADHD in adults [29]. Only the questions
psychiatric interview (the Mini-International pertaining to symptoms in adulthood would need to be
Neuropsychiatric Interview; MINI) under administered (since presence of symptoms in childhood
supervision by the PI or nominated deputy to exclude would already be established).
those who have a clinically significant anxiety disorder
and current episode of major depression, significant Randomisation and enrolment procedure
risk of self harm and active substance misuse/ Participants will be randomly allocated to one of the two
dependence in last three months. Participants will also treatments. Randomization will be performed by an in-
be excluded if they have an acquired brain injury, a dependent group in another service in the same NHS
primary diagnosis of psychosis or bipolar disorder, a Trust using a concealed sequence. The sequence will be
pervasive developmental disorder, a diagnosis of a generated using randomization tables and fixed-length
personality disorder or any other primary clinical blocks (length concealed), stratified for gender. The se-
diagnosis whereby participation in the trial would be quence will be generated by one named individual and
inappropriate to their clinical needs. put into numbered sealed envelopes. The envelopes will
2. Participants with a Verbal IQ of less than 80 will be be kept by another named individual (the independent
excluded from taking part owing to the verbal and researcher) in a locked drawer to which only she has ac-
cognitive elements of the intervention. cess. When a participant is suitable for randomization
3. Patients who are considered by the research the ADHD assistant will email the independent resear-
psychologist in discussion with the PI to be unable cher giving the participant number and gender. The
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independent researcher will reply by email with the allo- Assessments

cation and will record this along with the participant Wherever possible, assessments will be carried out at
number and gender in an electronic secured access file. the adult ADHD Service. If the participant is unable to
The individual assignments will be available to the attend an appointment, an alternative appointment may
Adult ADHD team on a need to know basis. The local be offered either at the participant’s convenience if not
statistician/s will be independent and will not have ac- yet randomized, or within the two weeks of the post-
cess to the treatment allocations. assessment due date. If it is not possible for the parti-
cipant to attend then questionnaires will be posted to
them and the remainder of the assessment will be car-
Randomized treatments
ried out over the phone.
Treatment as usual
Participants who drop out of treatment early will be
All participants in the trial will receive TAU. This will
assessed for outcomes as soon as possible rather than
include visits to their clinic doctor in the Service, if they
waiting for the normal follow-up.
have one, or visits to their local Specialist ADHD Ser-
It will not be practicable for the assistant psychologist
vice, CMHT or GP for management of their ADHD.
to remain blind to the treatment group allocation and so
They may be given some general advice but no specific
we will not attempt this.
advice with regard to strategies they may use to manage
their ADHD symptoms. There will be no additional
Measures
therapist involvement. The number of outpatient ses-
See Table 1 for a summary of measures given by timepoint.
sions will be recorded along with any treatments given
We have chosen to measure both changes in symptoms
to participants by the clinic doctor.
and functional impairment as our primary outcomes.

CBT Primary outcomes

In addition to treatment as usual, participants will also Rated by participant (self-report)
attend up to 15 weekly 50-minute CBT sessions over a
period of 30 weeks as well as their treatment as usual 1. Adult Barkley Current Symptoms Scale [30]
sessions at the clinic. They will have a sixteenth, follow- The Barkley Current Symptoms Scale includes
up CBT session at 42 weeks. questions that assess the frequency of the 18
During the early stages of treatment a shared formula- DSM–IV symptoms for ADHD. Items assess the
tion will be derived by patient and therapist. In the for- frequency of 9 inattentive and 9 hyperactive/
mulation links will be made between the individual’s impulsive symptoms on a scale ranging from
predisposition, their early life experiences and current 0 = “never or rarely” to 3 = “often” with a score of 2
behavioural coping and cognitions. Treatment will then or above indicating the presence of a symptom. The
focus on the problematic cognitions and behaviours presence of six or more symptoms for each subtype
identified in the assessment and agreed in the formulation, is considered clinically significant, in line with the
while drawing on a range of evidence-based strategies recommended threshold of six out of nine
such as thought records and behavioural experiments. symptoms in DSM- IV. This measure has strong
Therapists will also have access to a range of skills-based reliability and validity and has been widely used in
approaches as have been used in previous studies, as and ADHD research.
when they are indicated by the formulation (e.g. time 2. Work and Social Adjustment Scale [31]
management). A CBT manual has been developed but will This is a reliable and valid measure [32] that has
be updated iteratively. been used widely to assess impairment in
The aim will be to complete up to 15 sessions within functioning in relation to an identified problem. It
30 weeks. These will be scheduled approximately weekly consists of 5 questions each rated on an 8-point
several weeks ahead. If the patient is not able to attend scale (0 = “not at all impaired” and 8 = “very severely
an appointment because of ill health, the appointment impaired”). A higher score indicates higher
will be rescheduled to within one week’s time. If it is not impairment.
possible to rearrange the session within this timeframe,
a session may be held over the phone. Ideally no more Secondary outcomes
than three sessions in a row should take place over the Rated by participant (self-report)
phone. However if the choice is between not having a
session and offering a telephone session, a telephone ses- 3. Clinical Outcomes in Routine Evaluation Outcome
sion will always be offered, even if three consecutive measure (CORE-OM) [33]. This is a 34-item generic
phone sessions have already taken place. measure of psychological distress and is one of the
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Table 1 Measures by time-point

Completed by Visit 1 30 weeks 42 weeks Treatment Trial
(end of therapy) (trial end) discontinuation discontinuation
Eligibility assessment Clinic doctor/AP X
Informed Consent to trial AP X
Sociodemographic information AP X
CAADID AP X
MINI AP X
Adult Barkley Current Behaviour Scale P X X X X X
Work and Social Adjustment Scale P X X X X X
Clinical Outcomes in Routine Evaluation P X X X X
Outcome measure (CORE-OM)
Hospital Anxiety and Depression P X X X X
Scale (HADS)
ADHD Cognitions Questionnaire P X X X X
ADHD Behaviours Questionnaire P X X X X
Rosenberg Self-Esteem Scale P X X X X
Autism Spectrum Quotient Only if not already X
completed
Frost Multidimensional Perfectionism Scale P X X X X
Beliefs about Emotions Questionnaire P X X X X
Adult Barkley Current Behaviour Scale – I X X X X
Other report form
Global Impression scales -improvement IA, P, I, T X X X
Global Impression scales -severity AP/IA X (AP) X (IA) X (IA) X (IA)
Global Impression scales -satisfaction P X X X
Global Assessment of Functioning AP/IA X (AP) X (IA) X (IA) X (IA)
Rating of homework compliance T Session
by session
Ratings of treatment compliance, acceptance T X X X X
of model and therapeutic alliance
Medications, dosage, adherence AP X X X X
Number of sessions TAU AP
AP, Assistant psychologist; T, Therapist; P, Participant; I, Informant; IA, Independent assessor.

most widely used outcomes for psychological 6. ADHD Behaviours Questionnaire Participants will
therapies in primary and secondary care in the UK rate the extent to which they engage in certain
[34]. It has been shown to correlate well with other behaviours in relation to their ADHD. The reliability
measures of psychological distress in an aggregated and validity of this scale is also being evaluated in a
clinical sample and cut-off scores for determining parallel study.
clinical significance are available. 7. The Rosenberg Self-Esteem Scale [37].
4. Hospital Anxiety and Depression Scale (HADS) [35] This is a 10-item uni-dimensional measure of global
This is a 14-item scale with two subscales measuring self esteem, self-worth or acceptance that has been
anxiety and depression respectively. It has been shown to be reliable and valid including in psychiatric
found to reliably and validly assess the symptom outpatients [38].
severity and caseness of anxiety disorders and 8. The Autism Spectrum Quotient [39] *†
depression in psychiatric and primary care patients This is a 50-item questionnaire designed to assess
and in the general population [36]. autism spectrum symptoms in the general population.
5. ADHD Cognitions Questionnaire Participants will Results so far show good reliability. Studies in adults
rate various beliefs in relation to their ADHD. The show that the scale can distinguish between ASD and
reliability and validity of this scale is being evaluated controls as well as between ASD and psychiatric
in a parallel study. conditions such as OCD and social anxiety [39-42].
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The scale’s ability to distinguish ASD from ADHD is, 15. Global Assessment of Functioning [50]. A generic
however, limited [43]. The scale is therefore only used rather than diagnosis-specific scoring system of
as a screening tool in conjunction with the clinical psychological, social and occupational functioning
assessment and the initial research assessment and covers the range of positive mental health to
interview in assessing the presence of a possible severe psychopathology. For this study it will be
autistic spectrum disorder. To the authors’ used to provide a single score of functioning.
knowledge no alternative self-report scale of autistic While questions have been raised as to its utility for
spectrum disorder symptoms is available. individual patients, it appears to have acceptable
9. Global Impression scales (improvement** and reliability at the group level [51].
satisfaction**) (adapted from Guy 1976 and used 16. The independent evaluator will also be asked to say
previously in Deale et al. 1997; [44,45]) provide which group they thought the participant was in
self-rated global measures of improvement and and why (possible responses are “guess”, “the
treatment satisfaction on a seven point scale. participant told me” and “other, please state”).
Improvement is rated on a scale from 1 = “very
much better” to 7 = “very much worse”; satisfaction Therapist ratings
is rated on a scale from 1 = “very satisfied” to
7 = “very dissatisfied”. 17. Ratings of CBT compliance and adherence**.
10. Frost Multidimensional Perfectionism Scale, Number of CBT sessions attended, whether they
Unhealthy Perfectionism subscale [46], The original were face-to-face or telephone, their duration and
scale had 35 items, however a subsequent factor percentage completion of homework will be
analysis revealed two ‘higher order’ factors, recorded. At the end of CBT treatment, the
interpreted as Healthy (Organisation and Personal therapist will also score how well the participant
standards;13 items) and Unhealthy perfectionism adhered to the CBT approach, the extent to which
(Doubts about actions, Concerns over mistakes, the participant accepted the model of therapy and
Parental criticism, Parental expectations; 22 items) the therapeutic alliance on a five-point scale ranging
[47,48]. Responses are rated on 5-point Likert scale from “not at all” to “completely”. They will also rate
where 1 = “strongly disagree” and 5 = “strongly homework compliance on a scale of 0% to 100%
agree” and a higher score indicates greater completion on a session-by-session basis. These
perfectionism. measures were adapted from a previous RCT [52].
11. Beliefs about Emotions Questionnaire [49] A new measure was developed for the current study
This is a 12-item scale that assesses beliefs about whereby the therapist will also rate their impression
experiencing or expressing negative thoughts and of the strength of the therapeutic alliance on seven
emotions. It was validated using participants with point scale from 1 = “poor” to 7 = “excellent”.
chronic fatigue syndrome and healthy controls 18. Global Impression scales (severity and
and shows good internal reliability, validity and improvement) ** Global measures of severity and
sensitivity to change. Responses are rated on a improvement rated by the therapist (See 9). For
seven point Likert scale where 6 = “totally agree” and practical reasons these will be administered in the
0 = “Totally disagree”. CBT condition only.

Nominated informant ratings Other

12. Adult Barkley Current Symptoms Scale – Other 19. Medications and doses. At the each assessment
Report Form. This is an informant version of the point the assistant psychologist will take a record
Adult Barkley Current Symptoms Scale. of current medications and doses, any changes,
13. Global Impression Scales (improvement)**. Global compliance with medication. They will also ask
measure of improvement (see 9) rated by the about any adverse events/reactions that may not
nominated informant. yet have come to the attention of the trial
personnel.
Independent evaluator ratings 20. The details of TAU for all participants i.e. number
of sessions with the service managing their ADHD
14. Global Impression scales (severity and (the Maudsley Adult ADHD Service or their local
improvement)**. Global measures of severity and service) will be recorded.
improvement (See 9) rated by the independent * baseline only.
evaluator. ** 30 weeks and 42 weeks only.
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† This is routinely administered during clinic of 14.200 (SD = 7.2 assuming a correlation between pre
assessments. This will only be included in the and post measure of r = 0.5) and the Group 2 mean of
questionnaire pack if, for any reason, it has not 5.200 (SD = 9.05, assuming a correlation between pre
already been completed. and post of r = 0.5). This is also assuming that the com-
mon standard deviation is 9.050 (conservative estimate)
Ethics approval using a two group t-test with a 0.050 two-sided signifi-
The trial will be conducted in compliance with ethical cance level.
approval (City Road and Hampstead Research Ethics The intention to treat number is 23, however we will
Committee; reference 09/H0721/49) and R&D approval try to recruit 30 to each group to allow for dropouts.
(reference R&D2009/051).
The study opened to recruitment February 2010. Analysis plan

Sponsor 1. Between group effect sizes will be computed for the

The main Sponsor is South London and Maudsley NHS outcome measures.
Foundation Trust. 2. The two conditions i) CBT and ii) TAU will be
compared using random effects modelling. Intention
Independent overseers to treat analysis will be used. It is predicted that the
There will be a combined Trial Steering Committee (TSC) CBT group, covarying for baseline levels, will have
and Data monitoring and ethics committee (DMEC). They better results than the TAU group on the primary
will be responsible for monitoring progress of the trial and outcome (i.e. lower score on self-rated ADHD
serious adverse events or reactions. A trial management symptoms and scores indicating higher levels of
group will meet more regularly to discuss the day-to-day social and occupational functioning) and secondary
running and management of the trial. The combined TSC outcome measures. A more detailed analytic
and DMEC will aim to meet at least three times over the structure will be written before data analysis begins.
course of the trial.
Discussion
Therapists’ compliance with treatment manual
This is a randomized controlled trial to further investi-
Therapists’ compliance with treatment manuals will be
gate the feasibility and acceptability of CBT in addition
monitored in two ways. All therapists will receive a
to TAU as compared with TAU alone. This is the first
minimum of monthly face to face group supervision ses-
study to investigate individualized formulation-based
sions. All sessions will be audio-recorded and some re-
CBT for adults with ADHD using a randomized con-
cordings will be used to provide feedback to therapists
trolled design. It is hoped it will provide important infor-
on competence and treatment fidelity. Although the pa-
mation about the efficacy of this approach in this client
tient manual will be developed iteratively, the broad ap-
group. It will also provide information as to the feasibil-
proach and content of therapy will be agreed by the
ity of conducting a larger better-powered study in the
principal investigator and the clinicians involved in the
future, potential effect sizes and acceptability of the ap-
study (AD, TC, AR, KR) at the outset of the trial. Devia-
proach to patients. Finally it will provide some prelimin-
tions from this will be noted and feedback given to the
ary information about mechanisms of change as well as
therapist. Following completion of the treatment ses-
predictors of successful CBT outcome.
sions and of the patient and therapist manuals, 10% re-
A limitation of this study is that it is not designed to
corded sessions will be rated by two independent raters
match for therapist time and attention and so it will not
in order to assess adherence to the manual-defined
be possible to say whether any changes seen in the CBT
therapy.
group are specific to the CBT. Future studies should
evaluate this formulation-based approach alongside an
Analyses
active control condition.
Sample size
It is hoped this study will provide further information
The following power analysis is based on a previous
for people with ADHD, healthcare providers and commis-
study by Safren et al. [24] which compared CBT plus
sioners as to which treatments are most useful for ADHD
continued medication with continued medication only in
in adulthood. It will also provide some preliminary infor-
ADHD and used the same primary outcome symptom
mation about the mechanisms of change and predictors of
measure as will be used in the current study.
outcome in terms of symptoms and functioning.
A sample size of 23 in each group will have 90% power
to detect a difference in means of 9.000. This is the dif- Competing interests
ference between the change score of the Group 1 mean The authors declare they have no financial or nonfinancial competing interests.
Dittner et al. BMC Psychiatry 2014, 14:248 Page 10 of 11
http://www.biomedcentral.com/1471-244X/14/248

Authors’ contributions disorder: results of an open multicentre study. J Nerv Ment Dis 2007,
All authors were involved in conceptualising the project and in developing 195:1013–1019.
the cognitive behavioural therapy intervention. AD serves as the project’s 9. Ramsay JR, Rostain AL, Taylor F: Cognitive-Behavioural Therapy for Adult
principal investigator, and led the team in manuscript preparation. TC, KR ADHD. New York: An Integrative Psychosocial and Medical Approach; 2008.
and AR made substantial contributions to the manuscript and were involved 10. Rostain AL, Ramsay JR: A combined treatment approach for adults with
in critically revising the manuscript for intellectual content. All authors read ADHD–results of an open study of 43 patients. J Atten Disord 2006,
and approved the final manuscript. 10:150–159.
11. Solanto MV, Marks DJ, Mitchell KJ, Wasserstein J, Kofman MD: Development
of a new psychosocial treatment for adult ADHD. J Atten Disord 2008,
Acknowledgements 11:728–736.
Trudie Chalder, Antonia Dittner and Katharine Rimes acknowledge the 12. Wilens T, McDermott SP, Biederman J, Abrantes A, Hahesy A, Spencer T:
financial support from the National Institute for Health Research (NIHR) Cognitive therapy in the treatment of adults with ADHD: a
Mental Health Biomedical Research Centre at South London and Maudsley systematic chart review of 26 cases. J Cogn Psychother An Int Q 1999,
NHS Foundation Trust and King's College London. The views expressed are 13:215–226.
those of the authors and not necessarily those of the NHS, the NIHR or the 13. Zylowska L, Ackerman DL, Yang MH, Futrell JL, Horton NL, Hale TS, Pataki C,
Department of Health. Smalley SL: Mindfulness meditation training in adults and adolescents
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Charitable Funds (award ref 550). 14. Bramham J, Young S, Bickerdike A, Spain D, McCartan D, Xenitidis K:
The authors acknowledge the combined TSC and DMEC who are Evaluation of group cognitive behavioral therapy for adults with ADHD.
responsible for monitoring progress of the trial and serious adverse events or J Atten Disord 2009, 12:434–441.
reactions. They are: 15. Wiggins D, Singh K, Getz HG, Hutchins DE: Effects of brief group
Professor Richard G Brown (Chair) intervention for adults with attention deficit hyperactivity disorder.
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Author details
1 intervention with minimal therapist contact for adults with attention
King’s College London, King’s Health Partners, Behavioural and
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Developmental Psychiatry Clinical Academic Group, Maudsley Adult ADHD
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Service, South London and Maudsley NHS Foundation Trust, London, UK.
2 remediation programme for adults with Attention Deficit Hyperactivity
King’s College London, King’s Health Partners, Department of Psychology,
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Institute of Psychiatry, Psychology and Neuroscience, London, UK. 3King’s
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College London, Department of Psychology, Institute of Psychiatry,
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Psychology and Neuroscience, London, UK and Department of Psychology,
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University of Bath, Bath, UK. 4King’s College London, King’s Health Partners,
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