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

April 18, 2016 updated by: Antonia Dittner, South London and Maudsley NHS Foundation Trust

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, Se5 8AZ
        • Adult ADHD Service, South London and Maudsley NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult Barkley Current Behaviour Scale (Barkley 2006)
Time Frame: week 42
18-item self-report measure assessing ADHD symptoms, rated on a 4-point Likert scale
week 42
Work and Social Adjustment Scale (Mundt et al 2002)
Time Frame: week 42

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression Scales (Guy 1976)
Time Frame: week 42

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
Clinical Outcomes in Routine Evaluation (CORE-OM) (Evans et al 2002)
Time Frame: week 42
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
Hospital anxiety and depression scale (Zigmond and Snaith 1983)
Time Frame: week 42
A reliable and valid 14-item self-report scale assessing anxiety and depression symptoms, scored on a 4-point likert scale.
week 42
ADHD Beliefs Questionnaire
Time Frame: week 42
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
ADHD Behaviours Questionnaire
Time Frame: week 42
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
Rosenberg Self-Esteem Scale (Rosenberg 1965)
Time Frame: week 42
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
Informant-rated Adult Barkley Current Behaviour Scale (Barkley 2006)
Time Frame: week 42
This is the same as the Adult Barkley Current Behaviour scale but adapted to be completed by an informant.
week 42
Global assessment of functioning scale, DSM IV-TR
Time Frame: week 42
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
Frost Multidimensional Perfectionism Scale (Frost et al 1990), Doubts about actions, Concern over mistakes, Parental Criticism and Parental expectations subscales
Time Frame: Week 42
22 items, each measured on a 5-point Likert scale. The scale has good reliability and validity.
Week 42
Beliefs about Emotions Questionnaire (Rimes et al 2009)
Time Frame: week 42
The scale has 12 items assessed on a 7-point Likert scale. It has good reliability and validity.
week 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South London and Maudsley NHS Foundation Trust

Investigators

  • Principal Investigator: Antonia J Dittner, D Clin Psy, South London and Maudsley NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

April 1, 2010

First Posted (Estimate)

April 2, 2010

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/H0721/49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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