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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CBT plus treatment as usual
Treatment as usual
Sponsored by
South London and Maudsley NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Adult attention deficit hyperactivity disorder, cognitive-behavioural therapy, randomised controlled trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Adult ADHD Service, South London and Maudsley NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT plus treatment as usual

Treatment as usual

Arm Description

Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months

Outcomes

Primary Outcome Measures

Adult Barkley Current Behaviour Scale (Barkley 2006)
18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
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

Secondary Outcome Measures

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.
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.
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.
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".
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".
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.
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.
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.
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.
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.

Full Information

First Posted
March 19, 2010
Last Updated
April 18, 2016
Sponsor
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01098058
Brief Title
Cognitive-Behavioural Therapy (CBT) for Adult Attention Deficit Hyperactivity Disorder (ADHD)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South London and Maudsley NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Adult attention deficit hyperactivity disorder, cognitive-behavioural therapy, randomised controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT plus treatment as usual
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months
Intervention Type
Other
Intervention Name(s)
CBT plus treatment as usual
Intervention Description
16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months
Primary Outcome Measure Information:
Title
Adult Barkley Current Behaviour Scale (Barkley 2006)
Description
18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
Time Frame
week 42
Title
Work and Social Adjustment Scale (Mundt et al 2002)
Description
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
Time Frame
week 42
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scales (Guy 1976)
Description
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.
Time Frame
week 42
Title
Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)
Description
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.
Time Frame
week 42
Title
Hospital anxiety and depression scale (Zigmond and Snaith 1983)
Description
A reliable and valid 14-item self-report scale assessing anxiety and depression symptoms, scored on a 4-point likert scale.
Time Frame
week 42
Title
ADHD Beliefs Questionnaire
Description
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".
Time Frame
week 42
Title
ADHD Behaviours Questionnaire
Description
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".
Time Frame
week 42
Title
Rosenberg Self-Esteem Scale (Rosenberg 1965)
Description
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.
Time Frame
week 42
Title
Informant-rated Adult Barkley Current Behaviour Scale (Barkley 2006)
Description
This is the same as the Adult Barkley Current Behaviour scale but adapted to be completed by an informant.
Time Frame
week 42
Title
Global assessment of functioning scale, DSM IV-TR
Description
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.
Time Frame
week 42
Title
Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
Description
22 items, each measured on a 5-point Likert scale. The scale has good reliability and validity.
Time Frame
Week 42
Title
Beliefs about Emotions Questionnaire (Rimes et al 2009)
Description
The scale has 12 items assessed on a 7-point Likert scale. It has good reliability and validity.
Time Frame
week 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia J Dittner, D Clin Psy
Organizational Affiliation
South London and Maudsley NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adult ADHD Service, South London and Maudsley NHS Foundation Trust
City
London
ZIP/Postal Code
Se5 8AZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Barkley R.A. (2006) Attention-Deficit Hyperactivity Disorder - A Handbook for Diagnosis and Treatment. Third Edition, The Guildford Press, New York.
Results Reference
background
Citation
Rosenberg, M. (1965). Society and The Adolescent Self-Image. Princeton, N.J.: Princeton University Press.
Results Reference
background
Citation
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, 2000.
Results Reference
background
PubMed Identifier
6880820
Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Results Reference
background
PubMed Identifier
11772852
Citation
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. doi: 10.1192/bjp.180.1.51.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
11983645
Citation
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. doi: 10.1192/bjp.180.5.461.
Results Reference
background

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

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