Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098058
• Other study ID #: 09/H0721/49
• Status: Completed
• Phase: N/A
• First received: March 19, 2010
• Last updated: April 18, 2016
• Start date: April 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2016
• Source: South London and Maudsley NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• A diagnosis of adult ADHD according to NICE guidelines i.e. if there was evidence from both the participant and the informant (where available) that 1) the participant met DSM-IV criteria for Adult ADHD both in childhood and adulthood 2) that they experienced at least moderate psychological, social and/or educational or occupational impairment in multiple settings and 3) symptoms occurred in two or more settings including social, familial, educational and/or occupational settings. Participants will have received a diagnosis either from the Adult ADHD Service, Maudsley Hospital, London, UK or another specialist/secondary care service (in this case a copy of the diagnostic report will be required). Participants will either already be attending follow-up clinics, including psychoeducation workshops, or will have been recently referred to the service for medication follow-up or psychological treatment.

• Currently score 6 or more on the inattentive or hyperactive/impulsive subscale of the Adult Barkley Current Behaviour Scale

• Clinical severity of at least a moderate level (Clinical Global Impression score of 4 or above)

• Able to attend the clinic regularly and reliably

Exclusion Criteria:

• Clinically significant anxiety disorder

• Current episode major depression, current suicidality or self-harm (score of moderate or high suicidality on the M.I.N.I.)

• Acquired brain injury

• Primary diagnosis of psychosis or bipolar disorder

• Pervasive developmental disorder(score of <= 32 on Autism Spectrum Quotient - although if the assessor judges that items that confound with ADHD have caused the score to be elevated, people with scores >=32 can still enter the trial)

• Diagnosis of personality disorder

• Active substance misuse/dependence in last three months

• Verbal IQ <80

• Not able to comply with the requirements of a randomised controlled trial

• If the assessor does not perceive ADHD to be the primary problem

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Other:
• CBT plus treatment as usual
16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments
• Treatment as usual
Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months

Locations

Country	Name	City	State
United Kingdom	Adult ADHD Service, South London and Maudsley NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
South London and Maudsley NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Barkley R.A. (2006) Attention-Deficit Hyperactivity Disorder - A Handbook for Diagnosis and Treatment. Third Edition, The Guildford Press, New York.

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, 2000.

Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. — View Citation

Guy W (ed). ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, 1976.

Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. — View Citation

Rosenberg, M. (1965). Society and The Adolescent Self-Image. Princeton, N.J.: Princeton University Press.

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adult Barkley Current Behaviour Scale (Barkley 2006)	18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale	week 42	No
Primary	Work and Social Adjustment Scale (Mundt et al 2002)	A reliable and valid self-report measure of impaired functioning attributable to an identified problem.; It consists of 5 items, each rated on an 8-point scale	week 42	No
Secondary	Clinical Global Impression Scales (Guy 1976)	The Clinical Global Impression Scale is a 7-point scale that requires the clinician to rate the current severity of the patient's illness , relative to the past experience with patients with the same diagnosis. It is widely used in clinical treatment trials and is reliable and valid.; There are severity, improvement and satisfaction versions of the scale. Clinician, independent evaluator will complete severity measure. Participant, clinician, independent evaluator and informant will complete improvement measure; participant will complete satisfaction measure.	week 42	No
Secondary	Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)	The CORE-OM is a standardised public domain approach to audit, evaluation and outcome measurement for UK psychological therapy and counselling services. It consists of 34 items measured on a five-point Likert scale and assesses emotional distress and risk over the past week.	week 42	No
Secondary	Hospital anxiety and depression scale (Zigmond and Snaith 1983)	A reliable and valid 14-item self-report scale assessing anxiety and depression symptoms, scored on a 4-point likert scale.	week 42	No
Secondary	ADHD Beliefs Questionnaire	The ADHD Beliefs Questionnaire is a measure designed for the study. It consists of 28 items measured on a 5-point Likert Scale. Questions relate to specific beliefs that clinically have been noted to be associated with adult ADHD, e.g. "my lack of concentration will stop me achieving the things that I want".	week 42	No
Secondary	ADHD Behaviours Questionnaire	The ADHD Behaviours Questionnaire is a measure designed for the study. It consists of 29 items measured on a 5-point Likert Scale. Questions relate to specific behaviours that clinically have been noted to be associated with adult ADHD, e.g. "I avoid or put off doing things that I do not find interesting".	week 42	No
Secondary	Rosenberg Self-Esteem Scale (Rosenberg 1965)	The Rosenberg Self-Esteem Scale is a 10-item self-report measure of global self-esteem. It consists of 10 statements related to overall feelings of self-worth or self-acceptance. The items are answered on a four-point scale ranging from strongly agree to strongly disagree.	week 42	No
Secondary	Informant-rated Adult Barkley Current Behaviour Scale (Barkley 2006)	This is the same as the Adult Barkley Current Behaviour scale but adapted to be completed by an informant.	week 42	No
Secondary	Global assessment of functioning scale, DSM IV-TR	The Global Assessment of Functioning (GAF) is a numeric scale (0 through 100) used by mental health clinicians and physicians to subjectively rate the social, occupational, and psychological functioning of adults.	week 42	No
Secondary	Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales	22 items, each measured on a 5-point Likert scale. The scale has good reliability and validity.	Week 42	No
Secondary	Beliefs about Emotions Questionnaire (Rimes et al 2009)	The scale has 12 items assessed on a 7-point Likert scale. It has good reliability and validity.	week 42	No