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Trial registered on ANZCTR


Registration number
ACTRN12611000533998
Ethics application status
Approved
Date submitted
20/05/2011
Date registered
24/05/2011
Date last updated
19/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Cognitive Behavioral Therapy for Medicated Adults with Residual Attention Deficit Hyperactivity Disorder (ADHD) Symptoms: A Randomized Controlled Study
Scientific title
A randomized controlled trial on Cognitive Behaviour Therapy in Medication-Treated Adults with ADHD and Persistent Symptoms: The impact on ADHD symptoms, anxiety, depression, quality of life, coping style, emotional control, social functioning, antisocial behaviour and specific personality traits
Secondary ID [1] 259938 0
NIL
Universal Trial Number (UTN)
U1111-1120-5513
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 265544 0
Quality of life 265546 0
Emotional control 265548 0
Depression 265545 0
Personality traits 265560 0
Antisocial behaviour 265547 0
ADHD 265543 0
Social functioning 265549 0
Coping style 265559 0
Condition category
Condition code
Mental Health 265698 265698 0 0
Depression
Mental Health 265696 265696 0 0
Other mental health disorders
Mental Health 265697 265697 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the CBT condition receive 15 sessions of the Reasoning and Rehabilitation Programme for youth and adults with ADHD (R&R2ADHD) twice weekly, each lasting 90 minutes. R&R2ADHD is a structured, manualised programme that aims to decrease impairment of core ADHD symptoms and improve social, problem solving, and organizational skills. It consists of five treatment modules (1) neurocognitive, e.g. learning strategies to improve attentional control, memory, impulse control and planning, (2) problem solving, e.g. developing skilled thinking, problem identification, consequential thinking, managing conflict and making choices, (3) emotional control, e.g. managing feelings of anger and anxiety, (4) pro-social skills, e.g. recognition of the thoughts and feeling of others, empathy, negotiation skills and conflict resolution, and (5) critical reasoning, e.g. evaluating options and effective behavioural skills.The program is run in small groups by two psychologist who have extensive experience in CBT and have been trained in the R&R2ADHD program. Additionally the participants will meet with specific coaches once a week during the 2 month intervention period for 30 minutes to review sessions and to support participants to transfer skills learned in the group into their daily lives. Assessment will be at baseline, at the end of treatment in about two months and at three month follow-up.
Intervention code [1] 266633 0
Behaviour
Intervention code [2] 264353 0
Treatment: Other
Comparator / control treatment
Treament as usual control group (TAU). The TAU condition will continue their medication treatment but other treatment will not be controlled for. The TAU condition will not be asked to refrain from engaging in other interventions during the study period. They will be assessed at baseline, at the end of treatment phase in about two months and at three month follow-up. They will receive treatment after the follow-up (five months after baseline assessment).
Control group
Active

Outcomes
Primary outcome [1] 266472 0
CGI Clinical Global Impression Scale for ADHD (NIMH, 1985). Provided by Safren and colleagues (2005).
Timepoint [1] 266472 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Primary outcome [2] 266473 0
The Barkley ADHD Current Symptoms Scale (Barkley, 1998)
Timepoint [2] 266473 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Primary outcome [3] 266471 0
The Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS-PL) ADHD section (Kaufman et al., 1996)
Timepoint [3] 266471 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [1] 273840 0
The Rosenberg Self-Esteem Scale (Rosenberg, 1965)
Timepoint [1] 273840 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [2] 273845 0
The Gough Socialization Scale of the California Psychological Inventory (Gough & Bradley, 1996).
Timepoint [2] 273845 0
Both groups tested at baseline
Secondary outcome [3] 273843 0
The Maudsley Violence Questionnaire, MVQ (Walker, 2005).
Timepoint [3] 273843 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [4] 273836 0
Beck Anxiety Inventory (Beck & Steer, 1993)
Timepoint [4] 273836 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [5] 273838 0
The R&R2 ADHD Training Evaluation Self-report Scale (Young & Ross, 2007)
Timepoint [5] 273838 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [6] 273837 0
Beck Depression Inventory (Beck, Ward & Mendelson, 1961)
Timepoint [6] 273837 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [7] 273842 0
Eysenck Personality Questionnaire (EPQ; Eysenck & Eysenck, 1975).
Timepoint [7] 273842 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [8] 273846 0
The MINI International Neuropsychiatric Interview (Sheehan et al., 1998)
Timepoint [8] 273846 0
Both groups tested at baseline
Secondary outcome [9] 273839 0
Quality of Life Scale (QOLS; Flanagan, 1978).
Timepoint [9] 273839 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [10] 273844 0
The Adult Impulsiveness, Venturesomeness and Empathy Questionnaire (IVE; Eysenck & Eysenck, 1991).
Timepoint [10] 273844 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up
Secondary outcome [11] 273841 0
The COPE Scale Carver, Scheier, & Weintraub, 1989)
Timepoint [11] 273841 0
Both conditions tested at the same time, at baseline, at the end of treatment (two months) and at three month follow-up

Eligibility
Key inclusion criteria
A clinical diagnosis of ADHD and to be stable on prescribed ADHD medication for at least a month, i.e. stimulants (Ritalin, Ritalin Uno and Concerta), Atomoxetine or Bupropion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe mental illness, active drug abuse, verbal IQ estimated from clinical records to be below 85, no valid ADHD diagnosis or not prescribed/taking ADHD medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants receive specific numbers. An independent psychiatrist randomly allocates these numbers to either the CBT/MED experimental condition or the TAU/MED control condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization with computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3340 0
Iceland
State/province [1] 3340 0
Reykjavik

Funding & Sponsors
Funding source category [1] 264821 0
Government body
Name [1] 264821 0
Rannis The Icelandic Research Fund
Country [1] 264821 0
Iceland
Primary sponsor type
Hospital
Name
Landspitali - The National University Hospital of Iceland
Address
Hringbraut
101 Reykjavik
Country
Iceland
Secondary sponsor category [1] 263928 0
University
Name [1] 263928 0
Institute of Psychiatry at King's College London
Address [1] 263928 0
De Crespigny Park
London
SE5 8AF
Country [1] 263928 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266787 0
The Icelandic Bioethics Committee
Ethics committee address [1] 266787 0
Ethics committee country [1] 266787 0
Iceland
Date submitted for ethics approval [1] 266787 0
Approval date [1] 266787 0
01/09/2008
Ethics approval number [1] 266787 0
08-095-S1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32443 0
Address 32443 0
Country 32443 0
Phone 32443 0
Fax 32443 0
Email 32443 0
Contact person for public queries
Name 15690 0
Brynjar Emilsson
Address 15690 0
Landspitali
Kleppur
104 Reykjavik
Country 15690 0
Iceland
Phone 15690 0
+354 5434200
Fax 15690 0
Email 15690 0
brynjare@landspitali.is
Contact person for scientific queries
Name 6618 0
Jon F Sigurdsson
Address 6618 0
Landspitali
Hringbraut
101 Reykjavik
Country 6618 0
Iceland
Phone 6618 0
+354 5431000
Fax 6618 0
Email 6618 0
jonfsig@landspitali.is

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AICognitive behaviour therapy in medication-treated adults with ADHD and persistent Symptoms: A randomized controlled trial2011https://doi.org/10.1186/1471-244x-11-116
EmbaseA randomized controlled trial reporting functional outcomes of cognitive-behavioural therapy in medication-treated adults with ADHD and comorbid psychopathology.2017https://dx.doi.org/10.1007/s00406-016-0735-0
N.B. These documents automatically identified may not have been verified by the study sponsor.